GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814

K090124 · Depuy Mitek, A Johnson & Johnson Company · MAI · Mar 11, 2009 · Orthopedic

Device Facts

• Record ID: K090124
• Device Name: GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: MAI · Orthopedic
• Decision Date: Mar 11, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gryphon P BR Anchor, with ridged design, is intended for: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Device Story

Absorbable suture anchor; manufactured from Biocryl Rapide; 3.0 mm size. Preloaded on disposable inserter assembly. Used by surgeons in clinical settings for fixation of #2 suture to bone. Facilitates soft tissue reattachment to bone; aids healing in orthopedic repairs. Mechanical fixation device; no electronic or software components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Absorbable bone anchor; material: Biocryl Rapide; size: 3.0 mm; includes disposable inserter assembly; mechanical fixation principle; non-electronic; non-software.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation in shoulder, foot/ankle, knee, and elbow procedures, including rotator cuff, Bankart, SLAP, biceps, ligament, and tendon repairs.

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

• Gryphon BR Anchor (K073412)

Submission Summary (Full Text)

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MAR 1 1 2009

## 510(k) Summary

:

·

Gryphon P BR Anchor

| Submitter's Name and<br>Address: | DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Zheng Liu<br>Regulatory Affairs Specialist<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br>Telephone: [phone]<br>Facsimile: 508-977-6955<br>e-mail: [e-mail] |
| Name of Medical Device | Classification Name:<br>Single/Multiple component metallic bone<br>fixation appliances and accessories<br>Common/Usual Name:<br>Bone Anchor<br>Proprietary Name:<br>Gryphon P BR Anchor |
| Substantial Equivalence | The Gryphon P BR Anchor is substantially equivalent to the Gryphon<br>BR Anchor (K073412, January 17, 2008). |
| Device Classification | Single/Multiple component metallic bone fixation appliances and<br>accessories, classified as Class II, product code MAI and subsequent<br>codes GAM, GAS and GAT, regulated under 21 CFR 888.3030. |
| Device Description | The Gryphon P BR Anchor is an absorbable suture anchor<br>manufactured of "Biocryl Rapide" material. The anchor comes<br>preloaded on a disposable inserter assembly and is intended for fixation<br>of #2 suture to bone. The suture option is provided without needles.<br>The Gryphon P BR Anchor is provided as size 3.0 mm. |
| Indications for Use | The Gryphon P BR Anchor, with ridged design, is intended for:<br>Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair,<br>Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid |

Premarket Notification: Special
Gryphon P BR Anchor

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Confidential

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Repair, Capsular Shift or Capsulolabral Reconstruction;

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

## Safety and Performance

In support of the 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification.

Based on the Indications for Use, technological characteristics and safety and performance testing, the Gryphon P BR Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

Premarket Notification: Special Gryphon P BR Anchor

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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 a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle. The logo is black and white.

MAR 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Mitek, Inc. % Ms. Zheng Liu Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767

Re: K090124

Trade/Device Name: Gryphon P BR Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulation Class: Class II Product Code: MAI Dated: February 18, 2009 Received: February 20, 2009

Dear Ms. Liu:

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 interstate commerce 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Zheng Liu

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

hn Ahmed. for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K090124

Device Name: Gryphon P BR Anchor

Indications For Use:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

S.A.m.D.

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_

Premarket Notification: Special Gryphon P BR Anchor

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Confidential