Novastep v. Fusion - Complaint

Kenneth M. Motolenich-Salas (Bar No.
027499)
1
MotoSalas Law, PLLC
2 16210 North 63rd Street
Scottsdale, Arizona 85254
3
Telephone (202) 257-3720
4 E-mail: ken@motosalaslaw.com
5
Steven M. Coyle (Pro Hac Vice To Be Forthcoming)
6 Nicholas A. Geiger (Pro Hac Vice To Be Forthcoming)
CANTOR COLBURN LLP
7 20 Church Street, 22nd Floor
8 Hartford, Connecticut 06103
Telephone (860) 286-2929
9 Fax (860) 286-0115
10 E-mail: scoyle@cantorcolburn.com
MotoSalas Law, PLLC
ngeiger@cantorcolburn.com
16210 North 63rd Street
11
(202) 257-3720
Attorneys for Plaintiffs Novastep SAS and Novastep Inc.

12
IN THE UNITED STATES DISTRICT COURT
13
14 FOR THE DISTRICT OF ARIZONA
15 Novastep SAS, a French corporation, and Case No. ___________________

Novastep Inc., a New York corporation,
16
PLAINTIFFS NOVASTEP SAS
17 Plaintiffs, AND NOVASTEP INC.’S
18 ORIGINAL COMPLAINT
v. AGIANST DEFENDANT
19 FUSION ORTHOPEDICS, LLC
Fusion Orthopedics, LLC, an Arizona limited
20 liability company, (Jury Trial Demanded)
21
Defendant.
22
23 Plaintiffs, Novastep SAS and Novastep Inc. (hereinafter collectively “Novastep”),
24 do hereby, through their attorneys, allege as follows:
25 THE PARTIES
26 1. Plaintiff, Novastep SAS, is a French corporation, having a principal place of
27 business at Espace Performance III – Bâtiment P, 35769 Saint-Grégoire, France.
28
1 2. Plaintiff, Novastep Inc., is a New York corporation, having a principal place
2 of business at 30 Ramland Road, Suite 200, Orangeburg, New York 10962.
3 3. Upon information and belief, Defendant, Fusion Orthopedics, LLC,
4 (hereinafter “Fusion”), is an Arizona limited liability company, having a principal place of
5 business at 4135 S. Power Road #110, Mesa, Arizona 85212.
6 JURISDICTION AND VENUE
7 4. This is a claim for patent infringement and arises under the patent laws of
8 the United States, Title 35 of the United States Code. This Court has original jurisdiction
9 over the subject matter of this claim under 28 U.S.C. §§ 1331 and 1338(a).
10 5. This Court has personal jurisdiction over Fusion in that it transacts business
11 in this judicial district and/or has committed acts within this judicial district giving rise to
12 this action.
13 6. Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391(b),
14 (c), and 1400, because Fusion is subject to personal jurisdiction in this District, and
15 Fusion has committed acts of patent infringement in this District.
16 THE PATENT-IN-SUIT
17 7. On January 26, 2016, U.S. Design Patent D748,258 (“the ’258 patent”),
18 entitled “Clips for Surgical Purposes,” was duly and legally issued by the U.S. Patent and
19 Trademark Office (“USPTO”). A true and correct copy of the ’258 patent is attached
20 hereto as Exhibit A.
21 8. The ’258 patent is valid, enforceable and currently in full force and effect.
22 9. Novastep SAS is the owner and assignee of all substantial rights, title and
23 interest in the ’258 patent, including the right to bring this action and enforce the ’258
24 patent against infringers, and to collect damages for all relevant times.
25 10. Novastep Inc. is the exclusive licensee in the United States of the asserted
26 ’258 patent.
27 FACTUAL BACKGROUND
28 11. Novastep is a global medical device company specializing in the design,
2
1 development, and commercialization of products to treat conditions that affect the bones,
2 joints and soft tissues of the foot and ankle.
3 12. Novastep manufactures and sells a line of compression staples indicated for
4 osteotomies, arthrodeses and fractures of the forefoot, midfoot and rearfoot under the
5 trademark ARCAD® in the United States and worldwide.
6 13. Novastep’s ARCAD® compression staples are inserted using Novastep’s
7 proprietary implantation instrument.
8 14. The design of the ARCAD® compression staples implantation instrument is
9 protected by the ’258 patent.
10 15. Upon information and belief, Fusion designs, develops, manufactures and
11 sells compression staples under the name “DynaBridge” in the United States that are
12 indicated for fracture and osteotomy fixation and joint arthrodesis in the hand and foot.
13 16. Upon information and belief, Fusion designs, develops, manufactures and
14 sells medical device implantation instruments identified as “Tray Based Inserter[s]” that
15 are used by surgeons to insert Fusion’s DynaBridge compression staples.
16 17. Upon information and belief, Fusion manufactures or has manufactured for
17 it, uses, encourages others to use, sells, offers for sale, and/or imports its Tray Based
18 Inserters in 9mm, 11mm, 13mm, 15mm, 18mm, 20mm and 25mm sizes in the United
19 States under the product names: “DynaBridge TN-DB-0909; Tray Based Inserter 9mm,”
20 “DynaBridge TN-DB-1111; Tray Based Inserter 11mm,” “DynaBridge TN-DB-1313;
21 Tray Based Inserter 13mm,” “DynaBridge TN-DB-1515; Tray Based Inserter 15mm,”
22 “DynaBridge TN-DB-1818; Tray Based Inserter 18mm,” “DynaBridge TN-DB-2020;
23 Tray Based Inserter 20mm,” and “DynaBridge TN-DB-2525; Tray Based Inserter 25mm,”
24 (collectively the “DynaBridge Inserters”).
25 18. True and correct copies of Fusion’s Medical Device Identification Reports
26 for its DynaBridge Inserters from the U.S. Food and Drug Administration (“FDA”)
27 Database are attached hereto as Exhibit B.
28
3
1 19. As the side-by-side comparisons shown below reveal, Fusion has
2 misappropriated Novastep’s patented design in the accused products:
3 U.S. Design Patent D748,258 Fusion Accused Product
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11 FIG. 1
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15 FIG. 2
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18 FIG. 3
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25 FIG. 4
26 / / /
27 / / /
28 / / /
4
1 COUNT I
2 (Infringement of U.S. Design Patent No. D748,258)
3 20. Novastep repeats and realleges paragraphs 1-19, above, as though fully set
4 forth herein.
5 21. The claimed design of the ’258 patent is shown in Figures 1 through 6 of the
6 patent and described by the accompanying figure descriptions. See Exhibit A.
7 22. Fusion has infringed, and continues to infringe the ’258 patent by, inter alia,
8 making (or having made), using, offering to sell, selling, and/or importing in the United
9 States, including in the State of Arizona and within this District, products infringing the
10 ornamental design covered by the ’258 patent in violation of 35 U.S.C. § 271, including
11 but not limited to Fusion’s DynaBridge Inserters products.
12 23. Fusion infringes the ’258 patent because, inter alia, in the eye of an ordinary
13 observer familiar with the relevant prior art, giving such attention as a purchaser usually
14 gives, the claimed design of the ’258 patent and the design of at least Fusion’s
15 DynaBridge Inserters are substantially the same, such that the ordinary observer would be
16 deceived into believing that Fusion’s DynaBridge Inserters is the design claimed in the
17 ’258 patent.
18 24. Upon information and belief, Fusion also induced, and continues to induce,
19 others, including at least distributors, hospitals, and/or surgeons, to infringe the ’258
20 patent by encouraging and promoting the use and/or sale by others of DynaBridge
21 Inserters that infringe the ’258 patent in violation of 35 U.S.C. § 271(b).
22 25. Upon information and belief, Fusion has sold and continues to sell, offer to
23 sell, distribute and market products that infringe the ’258 patent, including the
24 DynaBridge Inserters, to end consumers and/or resellers with the intent that these parties
25 will use, market, offer to sell and/or sell the products in the United States in a manner that
26 infringes the ’258 patent.
27 26. Upon information and belief, Fusion knew or should have known that the
28 use, marketing, offering to sell and selling of the infringing products by Fusion or its
5
1 resellers and/or customers would directly infringe the ’258 patent.
2 27. Fusion’s acts of infringement of the ’258 patent were undertaken, and are
3 undertaken, without authority, permission or license from Novastep.
4 28. Novastep provided actual notice to Fusion of its infringement on repeated
5 occasions, including at least as early as August 1, 2019, and further including without
6 limitation the filing of this complaint.
7 29. Upon information and belief, Fusion’s acts of infringement have been or
8 will be undertaken with knowledge of the ’258 patent. Such acts constitute willful
9 infringement and make this case exceptional pursuant to 35 U.S.C. §§ 284 and 285, and
10 entitle Novastep to enhanced damages and reasonable attorneys’ fees.
11 30. Fusion’s infringement has damaged and continues to damage and injure
12 Novastep. The injury to Novastep is irreparable and will continue unless and until Fusion
13 is enjoined by this Court from further infringement.
14 PRAYER FOR RELIEF
15 WHEREFORE, Novastep respectfully asks this Court to enter judgment against
16 Fusion, and against respective subsidiaries, successors, parents, affiliates, officers,
17 directors, agents, servants and employees, and all persons in active concert or
18 participation with Fusion, granting the following relief:
19 A. Entry of a judgment that Fusion has directly and/or indirectly infringed the
20 ’258 patent and that such infringement has been willful;
21 B. Entry of a permanent injunction against Fusion, pursuant to 35 U.S.C. § 283
22 and/or the equitable powers of this Court, to prevent further direct and/or
23 indirect infringement of the ’258 patent;
24 C. An award of damages adequate to compensate Novastep for the
25 infringement that has occurred, but in no event less than a reasonable
26 royalty for the use made of the inventions of the ’258 patent as provided in
27 35 U.S.C. § 284;
28 D. Award Novastep treble damages as provided in 35 U.S.C. § 284;
6
1 E. An Order requiring Fusion to account for and pay to Novastep any and all
2 profits made by Fusion from sales of its infringing products pursuant to 35
3 U.S.C. § 289;
4 F. An Order requiring Fusion to pay Novastep its costs and attorneys’ fees in
5 this action pursuant to 35 U.S.C. § 285 and/or other applicable laws; and
6 G. Such other relief to which Novastep is entitled under law, and any other and
7 further relief that this Court or a jury may deem just and proper.
8 DEMAND FOR JURY TRIAL
9 Novastep demands a trial by jury on all issues so triable.
10 RESPECTFULLY SUBMITTED this 23rd day of September, 2020.
11
MotoSalas Law, PLLC
12
13
By:/s/Kenneth M. Motolenich-Salas
14 Kenneth M. Motolenich-Salas (027499)
15 16210 North 63rd Street
16 ken@motosalaslaw.com
17 Telephone (202) 257-3720
18 CANTOR COLBURN LLP

19 Steven M. Coyle (Pro Hac Vice To Be Forthcoming)
Nicholas A. Geiger (Pro Hac Vice To Be Forthcoming)
20 20 Church Street, 22nd Floor
21 Hartford, Connecticut 06103
scoyle@cantorcolburn.com
22 ngeiger@cantorcolburn.com
Telephone (860) 286-2929
23
Attorneys for Plaintiffs Novastep SAS and Novastep Inc.
24
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7
1 CERTIFICATE OF SERVICE
2 I hereby certify that on this 23rd day of September, 2020, I electronically transmitted
3 the foregoing document and all exhibits thereto to the Clerk’s Office using the CM/ECF
4 System for filing and transmittal of a Notice of Electronic Filing to all CM/ECF registrants
5 of record in this matter.
6 By: /s/ Kenneth M. Motolenich-Salas
7
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EXHIBIT A
Illlll llllllll Ill lllll llllll llll lllll lllll 111111111111111111111111111111111
USOOD748258S
c12) United States Design Patent (10) Patent No.: US D748,258 S

Gledel (45) Date of Patent: ** Jan.26,2016
(54) CLIPS FOR SURGICAL PURPOSES 4,950,281 A * 8/1990 Kirsch et al. .................. 606/207
D331,800 s * 12/1992 Han ............................. D24/143
(71) Applicant: NOVASTEP, St Gregoire (FR)
D341,886 s * 1111993 Stolte ........................... D24/143
D456,077 S * 412002 Etter et al. ................... D24/143
D485,359 S * 1/2004 McMichael et al. ......... D24/143
(72) Inventor: Gregory Gledel, Paris (FR) D526,444 S * 8/2006 Di Bitonto et al. ............ D28/55
D598,101 S * 8/2009 Keckstein et al. ........... D24/143
(73) Assignee: NOVASTEP (FR) D607,101 S * 12/2009 Andre .......................... D24/143
D707,816 S * 6/2014 LaMontagne et al ........ D24/143
(**) Term: 14 Years D707,817 S * 6/2014 Schallert ...................... D24/143
2008/0200923 Al * 8/2008 Beckman et al. ............. 606/108
2009/0030448 Al * 1/2009 Andre ........................... 606/205
(21) Appl. No.: 29/502,026 2013/0274755 Al* 10/2013 Van Dalen et al. ........... 606/107
(22) Filed: Sep. 11, 2014 * cited by examiner

(51) LOC (10) Cl. .. ... ... ... .. ... ... ... ... ... .. ... ... ... ... ... .. . 24-02 Primary Examiner - Wan Laymon
(52) U.S. Cl. Assistant Examiner - Mark Booker
USPC ......................................................... D24/143
(74) Attorney, Agent, or Firm - Cantor Colburn LLP
(58) Field of Classification Search
USPC ........ D24/143, 133, 147-148, 152-154, 146, (57) CLAIM
D24/176; D8/4, 14, 51-56, 58, 105, 107; I claim, the ornamental design for a clips for surgical pur-
D22/150; 7/125-136; 81/3.09, 3.44, poses, as shown and described.
81/300,342,348,355-362,364-366,
81/385-404, 407-418, 424.5, 426, 426.5, DESCRIPTION
81/427.5
CPC .... A61B 17/3403; A61B 10/06; A61B 17/30; FIG. 1 is a perspective view of clips for surgical purposes,
A61B 17/7062; A61B 18/1442; A61B showing my new design;
18/1445; A61B 17/3201; B25B 9102 FIG. 2 is a side elevation view thereof, the opposite side being
See application file for complete search history. a mirror image thereof;
FIG. 3 is a top plan view thereof;
(56) References Cited FIG. 4 is a perspective thereof in an alternate position;
FIG. 5 is a side elevation view thereof, the opposite side being
U.S. PATENT DOCUMENTS
a mirror image thereof; and,
2,667,678 A * 2/1954 Hargrave et al ................. 24/508 FIG. 6 is a front elevation view thereof.
D267,509 S * 1/1983 Wannag ....................... D24/143
D291,247 S * 8/1987 Weilbacher .................. D24/143 1 Claim, 3 Drawing Sheets
U.S. Patent Jan.26,2016 Sheet 1of3 US D748,258 S
FIG. 1
FIG.2
U.S. Patent Jan. 26, 2016 Sheet 2 of 3 US D748,258 S
FIG.3
FIG.4
U.S. Patent Jan.26,2016 Sheet 3 of 3 US D748,258 S
FIG.5
FIG. 6
EXHIBIT B
6/22/2020 Tray Based Inserter 9mm Medical Device Identification
DynaBridge TN-DB-0909
GUDID 00819034023714
Tray Based Inserter 9mm
FUSION ORTHOPEDICS, LLC

FDA.report (https://fda.report/) › / GUDID (/GUDID/) ›
/ FUSION ORTHOPEDICS, LLC (/Company/Fusion-Orthopedics-L-L-C) ›
/ 00819034023714 (/GUDID/00819034023714)
Orthopaedic bone staple driver
Primary Device ID 00819034023714
NIH Device Record Key 4d3dfa66-affb-48d5-b2a1-93299037114a
Commercial Distribution Status In Commercial Distribution
Brand Name DynaBridge
Version Model Number TN-DB-0909
Catalog Number TN-DB-0909
Company DUNS 080307067 (https://cage.report/DUNS/080307067)
Company Name FUSION ORTHOPEDICS, LLC (/Company/Fusion-Orthopedics-L-

L-C)
Device Count 1
DM Exempt false
Pre-market Exempt false
MRI Safety Status Labeling does not contain MRI Safety Information
Human Cell/Tissue Product false
Device Kit false
Device Combination Product false
Single Use true
Lot Batch true
Serial Number false
Manufacturing Date true
Expiration Date true
Donation Id Number false
Contains Natural Rubber Latex false
Labeled No Natural Rubber false

Latex
RX Perscription true
OTC Over-The-Counter false
https://fda.report/GUDID/00819034023714 1/4
Device Identifiers
Device Issuing Agency Device ID
GS1 00819034023714 [Primary]
FDA Pre-market Approvals/Notifications & deNovo
Premarket Notification: K181815 (/PMN/K181815)
FDA Product Code

JDR (/Product-Code/JDR) Staple, Fixation, Bone
Sterilization
Steralize Prior To Use true
Device Is Sterile false
[00819034023714]
Moist Heat or Steam Sterilization
Device Entry Metadata

Public Version Status New
Device Record Status Published
Public Version Number 1
Public Version Date 2019-05-07
Device Publish Date 2019-04-29
On-Brand Devices [DynaBridge]

00819034029273 Sizer Wheel Kit
(/GUDID/00819034029273)
00819034028016 Superelastic Nitinol Implant Style B 25mm x 20mm x

(/GUDID/00819034028016) 20mm

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(/GUDID/00819034027996) 15mm

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(/GUDID/00819034027965) 15mm

(/GUDID/00819034027958) 15mm

(/GUDID/00819034027941) 12mm
00819034027934 Superelastic Nitinol Implant Style A 15mm x 12mm x

(/GUDID/00819034027934) 12mm

(/GUDID/00819034027910) 10mm

(/GUDID/00819034027897) 10mm
00819034027880 Superelastic Nitinol Implant Style A 9 x 8 x 8mm

(/GUDID/00819034027880) (Single)
00819034027873 Drill Guide Style B 25mm

(/GUDID/00819034027873)

(/GUDID/00819034027866)

(/GUDID/00819034027859)

(/GUDID/00819034027842)
00819034027835 Drill Guide Style A 15mm

(/GUDID/00819034027835)

(/GUDID/00819034027828)

(/GUDID/00819034027811)
00819034027804 Sizer Wheel Style B

(/GUDID/00819034027804)

(/GUDID/00819034027798)
00819034027781 Sizer Wheel Style A

(/GUDID/00819034027781)

(/GUDID/00819034027774)

(/GUDID/00819034027255)
00819034025398 Tamp Large

(/GUDID/00819034025398)
00819034025381 Tamp Small

(/GUDID/00819034025381)
00819034025213 Superelastic Nitinol Implant System Style B 15 x 12 x

(/GUDID/00819034025213) 12mm
00819034025206 Superelastic Nitinol Implant Style B 15 x 12 x 12mm

(/GUDID/00819034025206)
00819034023776 Tray Based Inserter 25mm

(/GUDID/00819034023776)

(/GUDID/00819034023769)

(/GUDID/00819034023752)

(/GUDID/00819034023745)

(/GUDID/00819034023738)

(/GUDID/00819034023721)

(/GUDID/00819034023714)
00819034023653 Calibrated Drill 15mm Length 2.1mm

(/GUDID/00819034023653)
00819034023639 Targeting Rod Large

(/GUDID/00819034023639)
00819034023622 Targeting Rod Small

(/GUDID/00819034023622)
00819034023615 Calibrated Drill 2.8mm

(/GUDID/00819034023615)

(/GUDID/00819034023608)

(/GUDID/00819034023592)

(/GUDID/00819034023585) 20m

(/GUDID/00819034023578) 20mm

(/GUDID/00819034023561) 15mm

(/GUDID/00819034023554) 15mm

(/GUDID/00819034023547) 18mm

(/GUDID/00819034023530) 15mm

(/GUDID/00819034023523) 15mm
00819034023516 Superelastic Nitinol Implant System Style A 15 x 12 x

(/GUDID/00819034023516) 12mm
© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.
GUDID 00819034023721

/ 00819034023721 (/GUDID/00819034023721)
NIH Device Record Key 84044c73-9814-4eba-bea5-4abc1c5011b6

L-C)
Device Count 1
DM Exempt false
Device Kit false
Single Use true
Lot Batch true
Serial Number false

Latex
Device Identifiers
GS1 00819034023721 [Primary]
FDA Product Code

Sterilization
[00819034023721]


(/GUDID/00819034029273)

(/GUDID/00819034028016) 20mm

(/GUDID/00819034028009) 20mm

(/GUDID/00819034027996) 15mm

(/GUDID/00819034027989) 15mm

(/GUDID/00819034027972) 18mm

(/GUDID/00819034027965) 15mm

(/GUDID/00819034027958) 15mm

(/GUDID/00819034027941) 12mm

(/GUDID/00819034027934) 12mm

(/GUDID/00819034027910) 10mm

(/GUDID/00819034027897) 10mm

(/GUDID/00819034027880) (Single)

(/GUDID/00819034027873)

(/GUDID/00819034027866)

(/GUDID/00819034027859)

(/GUDID/00819034027842)

(/GUDID/00819034027835)

(/GUDID/00819034027828)

(/GUDID/00819034027811)

(/GUDID/00819034027804)

(/GUDID/00819034027798)

(/GUDID/00819034027781)

(/GUDID/00819034027774)

(/GUDID/00819034027255)
00819034025398 Tamp Large

(/GUDID/00819034025398)
00819034025381 Tamp Small

(/GUDID/00819034025381)

(/GUDID/00819034025213) 12mm

(/GUDID/00819034025206)

(/GUDID/00819034023776)

(/GUDID/00819034023769)

(/GUDID/00819034023752)

(/GUDID/00819034023745)

(/GUDID/00819034023738)

(/GUDID/00819034023721)

(/GUDID/00819034023714)

(/GUDID/00819034023653)

(/GUDID/00819034023639)

(/GUDID/00819034023622)

(/GUDID/00819034023615)

(/GUDID/00819034023608)

(/GUDID/00819034023592)

(/GUDID/00819034023585) 20m

(/GUDID/00819034023578) 20mm

(/GUDID/00819034023561) 15mm

(/GUDID/00819034023554) 15mm

(/GUDID/00819034023547) 18mm

(/GUDID/00819034023530) 15mm

(/GUDID/00819034023523) 15mm

(/GUDID/00819034023516) 12mm
© 2020 FDA.report
GUDID 00819034023738

/ 00819034023738 (/GUDID/00819034023738)
NIH Device Record Key 985629e0-71af-45f2-9ffb-0a33a83a830f

L-C)
Device Count 1
DM Exempt false
Device Kit false
Single Use true
Lot Batch true
Serial Number false

Latex
Device Identifiers
GS1 00819034023738 [Primary]
FDA Product Code

Sterilization
[00819034023738]


(/GUDID/00819034029273)

(/GUDID/00819034028016) 20mm

(/GUDID/00819034028009) 20mm

(/GUDID/00819034027996) 15mm

(/GUDID/00819034027989) 15mm

(/GUDID/00819034027972) 18mm

(/GUDID/00819034027965) 15mm

(/GUDID/00819034027958) 15mm

(/GUDID/00819034027941) 12mm

(/GUDID/00819034027934) 12mm

(/GUDID/00819034027910) 10mm

(/GUDID/00819034027897) 10mm

(/GUDID/00819034027880) (Single)

(/GUDID/00819034027873)

(/GUDID/00819034027866)

(/GUDID/00819034027859)

(/GUDID/00819034027842)

(/GUDID/00819034027835)

(/GUDID/00819034027828)

(/GUDID/00819034027811)

(/GUDID/00819034027804)

(/GUDID/00819034027798)

(/GUDID/00819034027781)

(/GUDID/00819034027774)

(/GUDID/00819034027255)
00819034025398 Tamp Large

(/GUDID/00819034025398)
00819034025381 Tamp Small

(/GUDID/00819034025381)

(/GUDID/00819034025213) 12mm

(/GUDID/00819034025206)

(/GUDID/00819034023776)

(/GUDID/00819034023769)

(/GUDID/00819034023752)

(/GUDID/00819034023745)

(/GUDID/00819034023738)

(/GUDID/00819034023721)

(/GUDID/00819034023714)

(/GUDID/00819034023653)

(/GUDID/00819034023639)

(/GUDID/00819034023622)

(/GUDID/00819034023615)

(/GUDID/00819034023608)

(/GUDID/00819034023592)

(/GUDID/00819034023585) 20m

(/GUDID/00819034023578) 20mm

(/GUDID/00819034023561) 15mm

(/GUDID/00819034023554) 15mm

(/GUDID/00819034023547) 18mm

(/GUDID/00819034023530) 15mm

(/GUDID/00819034023523) 15mm

(/GUDID/00819034023516) 12mm
© 2020 FDA.report
GUDID 00819034023745

/ 00819034023745 (/GUDID/00819034023745)
NIH Device Record Key d9b10cea-22f9-4f3c-afed-bc62cbbc713e

L-C)
Device Count 1
DM Exempt false
Device Kit false
Single Use true
Lot Batch true
Serial Number false

Latex
Device Identifiers
GS1 00819034023745 [Primary]
FDA Product Code

Sterilization
[00819034023745]


(/GUDID/00819034029273)

(/GUDID/00819034028016) 20mm

(/GUDID/00819034028009) 20mm

(/GUDID/00819034027996) 15mm

(/GUDID/00819034027989) 15mm

(/GUDID/00819034027972) 18mm

(/GUDID/00819034027965) 15mm

(/GUDID/00819034027958) 15mm

(/GUDID/00819034027941) 12mm

(/GUDID/00819034027934) 12mm

(/GUDID/00819034027910) 10mm

(/GUDID/00819034027897) 10mm

(/GUDID/00819034027880) (Single)

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00819034025398 Tamp Large

(/GUDID/00819034025398)
00819034025381 Tamp Small

(/GUDID/00819034025381)

(/GUDID/00819034025213) 12mm

(/GUDID/00819034025206)

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(/GUDID/00819034023592)

(/GUDID/00819034023585) 20m

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(/GUDID/00819034023547) 18mm

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(/GUDID/00819034023523) 15mm

(/GUDID/00819034023516) 12mm
© 2020 FDA.report
GUDID 00819034023752

/ 00819034023752 (/GUDID/00819034023752)
NIH Device Record Key a594b3f4-102c-4676-aa9f-bc3218c22100

L-C)
Device Count 1
DM Exempt false
Device Kit false
Single Use true
Lot Batch true
Serial Number false

Latex
Device Identifiers
GS1 00819034023752 [Primary]
FDA Product Code

Sterilization
[00819034023752]


(/GUDID/00819034029273)

(/GUDID/00819034028016) 20mm

(/GUDID/00819034028009) 20mm

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00819034025398 Tamp Large

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00819034025381 Tamp Small

(/GUDID/00819034025381)

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(/GUDID/00819034023769)

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(/GUDID/00819034023592)

(/GUDID/00819034023585) 20m

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(/GUDID/00819034023547) 18mm

(/GUDID/00819034023530) 15mm

(/GUDID/00819034023523) 15mm

(/GUDID/00819034023516) 12mm
© 2020 FDA.report
GUDID 00819034023769

/ 00819034023769 (/GUDID/00819034023769)
NIH Device Record Key a7b45b1d-35d7-4f8b-b9af-b6eb6f9a5412

L-C)
Device Count 1
DM Exempt false
Device Kit false
Single Use true
Lot Batch true
Serial Number false

Latex
Device Identifiers
GS1 00819034023769 [Primary]
FDA Product Code

Sterilization
[00819034023769]


(/GUDID/00819034029273)

(/GUDID/00819034028016) 20mm

(/GUDID/00819034028009) 20mm

(/GUDID/00819034027996) 15mm

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00819034025398 Tamp Large

(/GUDID/00819034025398)
00819034025381 Tamp Small

(/GUDID/00819034025381)

(/GUDID/00819034025213) 12mm

(/GUDID/00819034025206)

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(/GUDID/00819034023523) 15mm

(/GUDID/00819034023516) 12mm
© 2020 FDA.report
GUDID 00819034023776

/ 00819034023776 (/GUDID/00819034023776)
NIH Device Record Key 72a4ee05-029a-46ef-a14f-c8e17ddb8009

L-C)
Device Count 1
DM Exempt false
Device Kit false
Single Use true
Lot Batch true
Serial Number false

Latex
Device Identifiers
GS1 00819034023776 [Primary]
FDA Product Code

Sterilization
[00819034023776]


(/GUDID/00819034029273)

(/GUDID/00819034028016) 20mm

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00819034025398 Tamp Large

(/GUDID/00819034025398)
00819034025381 Tamp Small

(/GUDID/00819034025381)

(/GUDID/00819034025213) 12mm

(/GUDID/00819034025206)

(/GUDID/00819034023776)

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(/GUDID/00819034023547) 18mm

(/GUDID/00819034023530) 15mm

(/GUDID/00819034023523) 15mm

(/GUDID/00819034023516) 12mm
© 2020 FDA.report

Novastep v. Fusion - Complaint

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Novastep v. Fusion - Complaint

Hochgeladen von

Copyright:

Verfügbare Formate

Kenneth M. Motolenich-Salas (Bar No.

Attorneys for Plaintiffs Novastep SAS and Novastep Inc.

15 Novastep SAS, a French corporation, and Case No. ___________________

24 do hereby, through their attorneys, allege as follows:

26 1. Plaintiff, Novastep SAS, is a French corporation, having a principal place of

27 business at Espace Performance III – Bâtiment P, 35769 Saint-Grégoire, France.

18 CANTOR COLBURN LLP

c12) United States Design Patent (10) Patent No.: US D748,258 S

(22) Filed: Sep. 11, 2014 * cited by examiner

Tray Based Inserter 9mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone staple driver

Primary Device ID 00819034023714

NIH Device Record Key 4d3dfa66-affb-48d5-b2a1-93299037114a

Commercial Distribution Status In Commercial Distribution

Brand Name DynaBridge

Version Model Number TN-DB-0909

Catalog Number TN-DB-0909

Company DUNS 080307067 (https://cage.report/DUNS/080307067)

Company Name FUSION ORTHOPEDICS, LLC (/Company/Fusion-Orthopedics-L-

Pre-market Exempt false

Human Cell/Tissue Product false

Device Kit false

Device Combination Product false

Single Use true

Lot Batch true

Serial Number false

Manufacturing Date true

Expiration Date true

Donation Id Number false

Contains Natural Rubber Latex false

Labeled No Natural Rubber false

OTC Over-The-Counter false

GS1 00819034023714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181815 (/PMN/K181815)

FDA Product Code

Device Is Sterile false

Device Entry Metadata

Device Record Status Published

Public Version Number 1

Public Version Date 2019-05-07

Device Publish Date 2019-04-29

On-Brand Devices [DynaBridge]

00819034028016 Superelastic Nitinol Implant Style B 25mm x 20mm x

00819034028009 Superelastic Nitinol Implant Style B 20mm x 20mm x

00819034027996 Superelastic Nitinol Implant Style B 20mm x 15mm x

00819034027989 Superelastic Nitinol Implant Style B 18mm x 18mm x

00819034027972 Superelastic Nitinol Implant Style B 18mm x 18mm x

00819034027965 Superelastic Nitinol Implant Style B 18mm x 15mm x

00819034027958 Superelastic Nitinol Implant Style B 15mm x 15mm x

00819034027941 Superelastic Nitinol Implant Style B 15mm x 12mm x

00819034027934 Superelastic Nitinol Implant Style A 15mm x 12mm x

00819034027910 Superelastic Nitinol Implant Style A 13mm x 10mm x

00819034027897 Superelastic Nitinol Implant Style A 11mm x 10mm x

00819034027880 Superelastic Nitinol Implant Style A 9 x 8 x 8mm

00819034027873 Drill Guide Style B 25mm

00819034027866 Drill Guide Style B 20mm

00819034027859 Drill Guide Style B 18mm

00819034027842 Drill Guide Style B 15mm

00819034027835 Drill Guide Style A 15mm

00819034027828 Drill Guide Style A 13mm

00819034027811 Drill Guide Style A 11mm

00819034027804 Sizer Wheel Style B