GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T

K132241 · Depuy Mitek, A Johnson & Johnson Company · MAI · Nov 5, 2013 · Orthopedic

Device Facts

• Record ID: K132241
• Device Name: GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: MAI · Orthopedic
• Decision Date: Nov 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction Hip: Capsular Repair, Acetabular Labral Repair

Device Story

Cannulated, ribbed suture anchor for soft tissue-to-bone fixation; preloaded with Orthocord suture featuring pre-tied sliding ProKnot. Materials: non-absorbable PEEK or absorbable Biocryl Rapide (beta-TCP/PLGA composite). Used in orthopedic surgery for shoulder and hip repairs. Surgeon inserts anchor into bone; suture secures soft tissue. Pre-tied knot simplifies fixation process. Sterile, single-patient use.

Clinical Evidence

Bench testing only. In vitro fixation force testing conducted throughout two times the healing period to confirm performance equivalence to predicate devices. Material biocompatibility confirmed.

Technological Characteristics

Cannulated, ribbed anchor design. Materials: PEEK or Biocryl Rapide (beta-TCP/PLGA). Suture: Orthocord (polydioxanone/polyethylene composite). Pre-tied sliding knot technology. Sterile, single-use.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation in the shoulder (Bankart repair, SLAP lesion repair, capsular shift, capsulolabral reconstruction) or hip (capsular repair, acetabular labral repair).

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• BIORAPTOR® Knotless Suture Anchor (K121018, K093428)
• GRYPHON™ P BR Anchor (K090124, K100012)
• GRYPHON™ PEEK Anchor (K103712)

Submission Summary (Full Text)

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K132241 (1/2)

MITER SPORTS MEDIC

NOV - 5 2013

# 510(k) SUMMARY GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY

| Date Summary<br>Prepared | July 17, 2013 | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Submitter's<br>Name and<br>Address | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 | |
| Contact Person | Yayoi Fujimaki<br>Regulatory Affairs Senior Associate<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA | Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] |
| Name of<br>Medical Device | Trade Name:<br>GRYPHON™ Anchor w/PROKNOT™ Technology<br>fastener, fixation, biodegradable, soft tissue<br>Common Name: | |
| Device<br>Classification | MAI - Single/multiple component metallic bone fixation appliances and<br>미<br>accessories, classified as Class II, regulated per 21 CFR 888.3030.<br>HWC - Smooth or threaded metallic bone fixation fastener, Classified as<br>●<br>Class II, regulated per CFR 888.3040.<br>Orthopedic panel<br>요 | |
| Predicate<br>Device | BIORAPTOR® Knotless Suture Anchor (K121018, K093428)<br>트<br>GRYPHON™ P BR Anchor (K090124, K100012)<br>다<br>GRYPHON™ PEEK Anchor (K103712)<br>E | |
| Indications for<br>Use | Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral<br>Reconstruction<br>Hip: Capsular Repair, Acetabular Labral Repair | |
| Device<br>Description | The proposed device is a suture-anchor to be used for soft tissue fixation to<br>bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-<br>absorbable PEEK (Polyetheretherketone) or absorbable Biocry18 Rapide "<br>(composite of ß-TCP and PLGA copolymer). Orthocord suture (absorbable<br>polydioxanone (PDS®) and non-absorbable polyethylene braided composite<br>suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding<br>knot (ProKnot knot). The device is provided as sterile; the device is for single<br>patient use only. | |

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## ( ) DePuy Synthes MITEK SPORTS MEDICINE

comments or folonion gobseries

1

| Comparison of<br>Technological<br>Characteristics | Substantial equivalence to the predicate devices has been justified by similarity<br>of indications, design, material, operation principle and device performance data.<br>Performance testing ensured that there is no new issue of safety and efficacy. |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and<br>Performance | Non-clinical Testing<br>Performance requirement of the proposed device is to secure soft tissue to bone<br>to heal. Fixation force testing was conducted under in vitro condition throughout<br>two times of healing period, and substantial equivalence of fixation performance<br>to the predicate device has been confirmed. Material biocompatibility has been<br>also confirmed. The proposed device raises no new issue of safety and efficacy. |
| Substantial<br>Equivalence | Based on technological characteristics comparison and performance evaluation,<br>the proposed device is concluded to be substantially equivalent to the predicate<br>devices. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines extending from its body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 5, 2013

DePuy Mitek, a Johnson and Johnson company Ms. Yavoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, Massachusetts 02767

- Re: K132241
Trade/Device Name: GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: September 25, 2013 Received: September 26, 2013

Dear Ms. Fujimaki:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to-legally-marketed-predicate-devices-marketed-in-interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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### Page 2 - Ms. Yayoi Fujimaki

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Erin詞為Keith

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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**DePuySynthes**
MITEK SPORTS MEDICINE

# Indications for Use

510(k) Number (if known): K132241

Device Name: GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY

Indications for Use:

GRYPHON ANCHOR w/PROKNOT TECHNOLOGY is indicated for followings.

Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction Hip: Capsular Repair, Acetabular Labral Repair

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use __

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

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