PEEK KNOTLESS ANCHORS

K070389 · Biomet Sports Medicine, Inc. · HWC · Aug 9, 2007 · Orthopedic

Device Facts

• Record ID: K070389
• Device Name: PEEK KNOTLESS ANCHORS
• Applicant: Biomet Sports Medicine, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Aug 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valgus Reconstruction; and Mid and Forefoot Reconstruction Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement The PEEK Knotless Anchors are single-use devices.

Device Story

PEEK Knotless Anchors are soft tissue fixation devices used by surgeons in orthopedic procedures. Comprised of PEEK-Optima polymer, these anchors facilitate reattachment of soft tissue to bone in various joints (shoulder, wrist/hand, ankle/foot, elbow, knee). The device is implanted during surgery to secure ligaments or tendons, aiding in structural repair and stabilization. As a single-use, knotless system, it simplifies surgical technique by eliminating the need for manual knot tying, potentially reducing operative time and improving consistency in tissue tensioning. The device is intended for professional use in clinical/surgical settings.

Clinical Evidence

No clinical data provided. Substantial equivalence established via non-clinical laboratory testing.

Technological Characteristics

Material: PEEK-Optima polymer. Design: Knotless soft tissue anchor. Available in four diameters. Single-use. Class II device (21 CFR 888.3040).

Indications for Use

Indicated for soft tissue reattachment in shoulder, wrist/hand, ankle/foot, elbow, and knee procedures. Includes repairs for ligaments, tendons, and capsules (e.g., Bankart, SLAP, rotator cuff, Achilles, collateral ligaments). Single-use only.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• ALLthread™ PEEK Suture Anchors (K060693)
• Resorbable Interference Screw (K041274)
• Soft Tissue Screw and Washer (K012572)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "BIOMET" in a stylized, blocky font. Above the word, there is a sequence of numbers and letters: K070389. The letters and numbers are handwritten and appear to be part of a code or identifier. The word "BIOMET" is the most prominent feature of the image.

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### 510(k) Summary

AUG - 9 2007

| Preparation Date: | February 8, 2007 |
|----------------------|----------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Sports Medicine, Inc. (formerly known as Arthrotek, Inc.) |
| Contact Person: | Susan Alexander |
| Proprietary Name: | PEEK Knotless Anchors |
| Common Name: | Soft tissue anchor |
| Classification Name: | Smooth or threaded metallic bone fixation fastener (21 CFR §888.3040), HWC |

## Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

| • ALLthread™ PEEK Suture Anchors | K060693 | Arthrotek, Inc. |
|----------------------------------|---------|-----------------|
| • Resorbable Interference Screw | K041274 | Arthrotek, Inc. |
| • Soft Tissue Screw and Washer | K012572 | Arthrotek, Inc. |

Device Description: The PEEK Knotless Anchors are soft tissue anchors available in four diameters and comprised of PEEK-Optima® polymer.

#### Indications for Use:

Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair

Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction

Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valgus Reconstruction; and Mid and Forefoot Reconstruction

Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair

Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement

The PEEK Knotless Anchors are single-use devices.

Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the PEEK Knotless Anchors are similar or identical to the predicate devices.

5-1 MAHING ADDRESS SHIPPING ADDRESS 1:0. Box 587 56 F. Bell Drive Warsaw, IN 46581 0587 Warsaw, IN 46582 ()FFICIE PAN E-MAII. 574.267.66.39 574.367.8147 [e-mail]

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070389

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510(k) Summary 510(k) Notification: PEEK Knotless Anchors Biomet Sports Medicine, Inc.

______________________________________________________________________________________________________________________________________________________________________________

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc. unless otherwise noted. PEEK-OPTIMA® is a registered trademark of Invibio, Inc.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines, which is the department's symbol. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Sports Medicine, Inc. % Ms. Susan Alexander Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587

AUG = 9 2007

Re: K070389

> Trade/Device Name: PEEK Knotless Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 4, 2007 Received: June 5, 2007

Dear Ms. Alexander:

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. Iisting 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 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.

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#### Page 2 -- Ms. Susan Alexander

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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or at Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Babare Buchem

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):

Device Name: PEEK Knotless Anchors

Indications For Use:

Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair

Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction

Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valqus Reconstruction; and Mid and Forefoot Reconstruction

Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair

Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement

The PEEK Knotless Anchors are single-use devices.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Senbere Budu

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number_ 4 - 1 R070389