4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B

K020043 · Arthrex, Inc. · HWC · Apr 2, 2002 · Orthopedic

Device Facts

• Record ID: K020043
• Device Name: 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B
• Applicant: Arthrex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Apr 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Bio-Tenodesis Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, and hand/wrist. Specifically; - Shoulder. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction - Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair - Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow. Radial Collateral Ligament Reconstruction - Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Device Story

Arthrex Bio-Tenodesis Screw is a threaded, fully cannulated, bioabsorbable poly(L-lactide) (PLLA) anchor; used for fixation of ligament and tendon graft tissue. Device implanted by surgeons in clinical settings (OR) during shoulder, elbow, foot/ankle, and hand/wrist procedures. Bone preparation via drill required prior to insertion using reusable driver. Provides mechanical fixation of soft tissue to bone; facilitates healing/reconstruction. Benefits include bioabsorbable material, eliminating need for secondary removal surgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Material: Poly(L-lactide) (PLLA). Design: Threaded, fully cannulated anchor with rounded head. Dimensions: 4.0 mm and 5.5 mm models. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for fixation of ligament and tendon graft tissue in orthopedic surgeries of the shoulder, elbow, foot/ankle, and hand/wrist in patients requiring such reconstruction or repair.

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.

Submission Summary (Full Text)

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APR 0 2 2002

Ko 20043

# 510(k) Summary

| 510(k) Number: | |
|-----------------|------------------------------------------------|
| Company: | Arthrex, Inc. |
| Address: | 2885 S. Horseshoe Dr., Naples, FL 34104 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact: | Ann Waterhouse |
| Trade Name: | Arthrex Bio-Tenodesis Screw |
| Common Name: | Suture Anchor |
| Classification: | Fastener, Fixation, Biodegradable, Soft Tissue |

MAI

#### Description:

Product Code:

The Arthrex Bio-Tenodesis Screw is manufactured using poly(L-lactide). It is a threaded anchor which is fully cannulated and has a rounded head. The Bio-Tenodesis Screw is available with a reusable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a drill of the appropriate size.

#### Indications for Use:

The Arthrex Bio-Tenodesis Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, and hand/wrist. Specifically;

- Shoulder. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow. Radial Collateral Ligament Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

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### Substantial Equivalence:

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference domonotrouled to be be a vice Tenodesis Screw and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the material is well characterized and has been used in predicate device with similar indications. The device, as designed, is as safe and effective as predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 0 2 2002

Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex Inc. 2885 South Horseshoe Drive Naples, Florida 34104

Re: K020043

Trade/Device Name: Arthrex Bio-Tenodesis Screws, 4.0 mm and 5.5 mm Models Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 4, 2002 Received: January 7, 2002

Dear Ms. Waterhouse:

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 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. Ann Waterhouse

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,
Mark N Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

KOLOOFS 510(k) Number (if known):

Device Name:

Asthrex B.b - Tenodes . S

## Indications for Use:

The Arthrex Bio-Tenodesis Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, and hand/wrist. Specifically;

- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millerson

(Option Format 3-10-98)

vision Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K020043

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