SYNTHES BIORESORBABLE SUTURE ANCHOR

K994161 · Synthes (Usa) · MAI · Jul 28, 2000 · Orthopedic

Device Facts

• Record ID: K994161
• Device Name: SYNTHES BIORESORBABLE SUTURE ANCHOR
• Applicant: Synthes (Usa)
• Product Code: MAI · Orthopedic
• Decision Date: Jul 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Bioresorbable Suture Anchor is intended to repair ligamentous and tendinous defects in the shoulder, knee, foot, ankle, hand and wrist.

Device Story

Synthes Bioresorbable Suture Anchor is a cylindrical, injection-molded poly(L/DL-lactide) fastener used for soft tissue fixation. Device dimensions range from 5.0 mm to 20.0 mm in length with a 3.5 mm outside diameter and metric thread profile. It is designed for use with commercially available non-resorbable USP size #0, #1, or #2 sutures. The anchor features a drive mechanism to facilitate an interference fit onto a suture anchor driver. Used by surgeons in clinical settings to secure ligaments and tendons to bone, the device provides mechanical fixation during the healing process before undergoing bioresorption. It benefits patients by providing a temporary, biodegradable fixation solution for orthopedic repairs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: poly(L/DL-lactide). Form factor: cylindrical, 3.5 mm diameter, 5.0-20.0 mm length. Features: metric thread profile, drive mechanism for interference fit. Energy source: none (mechanical). Sterilization: not specified.

Indications for Use

Indicated for repair of ligamentous and tendinous defects in shoulder, knee, foot, ankle, hand, and wrist. Prescription use only.

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

• Linvatec's Bio-Anchor Absorbable Suture Anchor
• Mitek's Threaded Anchor (Fastin)
• Mitek's GII Anchor

Submission Summary (Full Text)

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# QUL 288 2000

### Attachment IX

SUBMITTER

## Summary of Safety and Effectiveness Information [510(k) Summary]

K994161

Synthes (USA) 1690 Russell Road Paoli. PA 19301 [phone]

Contact: Sheri L. Musgnung

DEVICE NAME:

COMMON OR USUAL NAME

DEVICE CLASSIFICATION:

PREDICATE DEVICE:

DESCRIPTION:

[phone]

Contact: Shari L. Musgnug

Synthes Bioresorbable Suture Anchor

Fastener, Fixation, Biodegradable, Soft Tissue

Class II, CFR Unclassified

Linvatec's Bio-Anchor Absorbable Suture Anchor Mitek's Threaded Anchor (Fastin) Mitek's GII Anchor

Synthes Bioresorbable Suture Anchors are injection molded from the poly(L/DL-lactide). Synthes Bioresorbable Suture Anchor is cylindrical in shape, ranges from 5.0 mm - 20.0 mm in length, has an outside diameter of 3.5 mm, and has a thread with metric profile. It is recommended to use a commercially available non-resorbable size #0, #1, or #2 USP suture in combination with this device. The Bioresorbable Suture Anchor has a drive mechanism which facilitates an interference fit of the device onto the suture anchor driver.

#### INTENDED USE:

Synthes Bioresorbable Suture Anchor is intended to repair ligamentous and tendinous defects in the shoulder, knee, foot, ankle, hand and wrist.

Synthes (USA) Bioresorbable Suture Anchor CONFIDENTIAL

COOOOTE

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2000

Ms. Sheri Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301

Re: K994161

Trade Name: Synthes (USA) Bioresorbable Suture Anchor Regulatory Class: II Product Code: MAI Dated: June 14, 2000 Received: June 15, 2000

Dear Ms. Musgnung:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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### Page 2 - Ms. Sheri Musgnung

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

vonne R. Lochner

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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#### Indications for Use Statement 2.0

Page

510(k) Number (if known):

Synthes Bioresorbable Suture Anchor Device Name:

Indications For Use:

Synthes Bioresorbable Suture Anchor is intended to repair ligamentous and tendinous defects in the shoulder, knee, foot, ankle, hand and wrist.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109) OR

Over-The-Counter Use

Danne P. Vochner.

(Division Sign-Off) Division of General Restorativ. Devices 510(k) Number \$99416

Synthes (USA) Bioresorbable Suture Anchor CONFIDENTIAL

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