BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B

K023119 · Arthrex, Inc. · HTN · Dec 18, 2002 · Orthopedic

Device Facts

• Record ID: K023119
• Device Name: BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
• Applicant: Arthrex, Inc.
• Product Code: HTN · Orthopedic
• Decision Date: Dec 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bi-Cortical Bio-Post and Washer is intended as an anchor device for suture or to secure soft tissue directly to bone.

Device Story

Bi-Cortical Bio-Post and Washer is a biodegradable orthopedic fixation device; used to anchor sutures or secure soft tissue directly to bone. Composed of poly(L-lactide) acid (PLLA); device length 35 mm; head width 6.5 mm; washer increases diameter to 16.5 mm. Used by surgeons in clinical settings for soft tissue-to-bone attachment. Device provides mechanical fixation during healing; material is biocompatible and biodegradable.

Clinical Evidence

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

Technological Characteristics

Material: Poly(L-lactide) acid (PLLA). Form factor: 35 mm length, 6.5 mm head width, 16.5 mm diameter with washer. Principle: Mechanical fixation via biodegradable anchor. Sterilization: Not specified.

Indications for Use

Indicated for use as an anchor device for suture or to secure soft tissue directly to bone in patients requiring orthopedic fixation.

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

• Arthrex, Inc. Bio-Post and Washer System
• Synthes(USA), Synthes Bioresorbable Suture Anchor
• Bionx Implants, LTD., Smartwedge ACL
• Bionx Implants, LTD., Smart Screw ACL
• Bionx Implants, LTD., Biocuff

Submission Summary (Full Text)

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DEC 1 8 2002

Ko23/119

# 510(k) Summary

| 510(k) Number: | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ann Waterhouse, Regulatory Affairs Specialist |
| Date Prepared: | September 11, 2002 |
| Trade/Proprietary Name: | Bi-Cortical Bio-Post and Washer |
| Product Code: | MAT HTN/HWC |
| Classification Name: | Fastener, Fixation, Biodegradable, Soft Tissue |
| Predicate Devices: | Arthrex, Inc. Bio-Post and Washer System,<br>Synthes(USA), Synthes Bioresorbable Suture Anchor,<br>Bionx Implants, LTD., Smartwedge ACL, Bionx<br>Implants, LTD>, Smart Screw ACL, Bionx Implants,<br>LTD., Biocuff. |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

### Intended Use:

The Bi-Cortical Bio-Post and Washer is intended as an anchor device for suture or to secure soft tissue directly to bone.

## Description:

Arthrex, Inc. Bio-Post and Washer is intended for suture fixation or securing soft tissue to bone. The Bio-Post and Washer is composed of poly(I-lactide) acid, PLLA which is biodegradable and biocompatible. It is 35 mm in length and 6.5 mm wide at the head of the Bio-Post. The addition of the washer increases the diameter to 16.5 mm.

## Substantial Equivalence:

The Arthrex, Inc. Bio-Post and Washer is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Arthrex Bio-Post and Washer and predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K023119

Trade/Device Name: Bi-Cortical Bio-Post and Washer™ Regulation Number: 21 CFR 888.3030 and 21 CFR 888.3040 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories; and Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTN and HWC Dated: September 18, 2002 Received: September 19, 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 mav 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. This letter will allow you to begin marketing your device as described in your Section 510(k)

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Page 2 - Ms. Ann Waterhouse

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 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,

Muriam C. Provost

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

Enclosure

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## Page 1 of 1

510(k) Number (if known):

Device Name: Arthrex Bio-Post and Washer

Indications for Use:

The Arthrex Bio-Post and Washer is intended as an anchor device for suture or to secure soft tissue directly to bone.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Option Format 3-10-98)

Muriam C. Provost

on of General, Restorative and Neurological Devices

Number K 023/19

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