SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS

K983592 · Sulzer Orthopedics, Inc. · HWC · Jan 28, 1999 · Orthopedic

Device Facts

• Record ID: K983592
• Device Name: SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS
• Applicant: Sulzer Orthopedics, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jan 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sulzer Orthopedics Sysorb Interference Screws are intended for use in tibial and femoral fixation (primary anchorage) of the autologous tendon-transplants as it is used in the reconstruction of the cruciate ligaments of the human knee.

Device Story

Bioresorbable interference screw; used for primary anchorage of autologous tendon-transplants in cruciate ligament reconstruction of human knee. Manufactured from Poly (D,L-Lactide) (Resomer R208); amorphous polymer derivative of lactic acid. Features nearly symmetrical thread profile; continuous turbine-shaped driving feature allows torque application along full screw length; enables implantation without pre-drilling or tapping. Provides initial interference fit fixation; resorbs over time as graft incorporates into surrounding bone. Used by orthopedic surgeons in clinical/surgical settings. Benefits patient by providing secure graft fixation while eliminating need for permanent hardware removal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Poly (D,L-Lactide) (Resomer R208) bioresorbable polymer. Design: Symmetrical thread profile; turbine-shaped driving feature for torque application. Mechanical fixation: Interference fit. No drilling or tapping required. Non-electronic; no software.

Indications for Use

Indicated for tibial and femoral fixation (primary anchorage) of autologous tendon-transplants during cruciate ligament reconstruction of the human knee.

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.

Reference Devices

• Smith & Nephew (Acufex) Endo-Fix
• Instrument Makar Biologically Quiet
• Arthrex Bio-Interference
• Linvatec Bioscrew

Submission Summary (Full Text)

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## 510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics Sysorb Interference Screw.

| Submitter/<br>Author. Rep .: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>[phone] |
|------------------------------|-----------------------------------------------------------------------------------------|
| Manufacturer: | Sulzer Orthopedics Ltd.<br>Grabenstrasse 25<br>CH-6341 Baar, Switzerland |
| Date: | October 8, 1998 |
| Contact Person: | Mitchell A. Dhority, RAC<br>Manager, Regulatory Affairs |
| Classification Name: | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation<br>fastener |
| Common/Usual Name: | Resorbable interference screw |
| Trade/Proprietary Name: | Sulzer Orthopedics Sysorb Interference Screw |

### PRODUCT DESCRIPTION

The Sulzer Orthopedics Sysorb Interference Screws are a bioresorbable interference screw used in attachment of autologous tendon tranfers in cruciate ligament reconstruction. The Sysorb interference screws are manufactured from the bioresorbable material Poly (D,L-Lactide) (Resomer R208), an amorphous polymer derivative of lactic acid. The screw provides an initial interference fit fixation of the tissue graft and resorbs over time as the graft is naturally incorporated into the surrounding structure.

The Sysorb Interference Screw uses a nearly symmetrical thread profile which takes into account both the strength of the material and the relative strength of cancellous bone. The design also allows the screw to be introduced without drilling or tapping. A continuous "turbine" shaped driving feature allows torque to be applied along the complete length of the screw upon implantation, thus minimizing the potential for fracture of the implant.

#### SPECIFIC DIAGNOSTIC INDICATIONS

The Sulzer Orthopedics Sysorb Interference Screws are intended for use in tibial and femoral fixation (primary anchorage) of the autologous tendon-transplants as it is used in the reconstruction of the cruciate ligaments of the human knee.

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## SUBSTANTIAL EQUIVALENCE

The Sulzer Orthopedics Sysorb Interference Screws are similar to the following competitive, commercially available resorbable interference screws:

- Smith & Nephew (Acufex) Endo-Fix 프
- Instrument Makar Biologically Quiet
- Arthrex Bio-Interference
- Linvatec Bioscrew

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1999

Mr. Mitchell A. Dhority Manager, Regulatory Affairs Sulzer Orthopedics Inc. 9900 Spectrum Drive Austin, Texas 78717

K983592 Re: SYSORB Resorbable Interference Screw Requlatory Class: II Product Codes: MAI, HWC, and GAT January 12, 1999 Dated: Received: January 14, 1999

Dear Mr. Dhority:

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 controls provisions The general controls provisions of the Act 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 requlations 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 General regulation (21 CFR Part 820) and that, Devices: 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 requlations.

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Page 2 - Mr. Mitchell A. Dhority

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.

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 Also, please note the Office of Compliance at [phone]. the regulation entitled, "Misbranding by reference to the regulation cherefox) hisbidian's ap sother 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,

Colin M. Hittle, Ph.D., M.D.

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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510(k) Number (if known): ___ 9 3 3 5 9 2

Device Name: Sulzer Orthopedics Sysorb Interference Screws

# Indications For Use:

The Sulzer Orthopedics Sysorb Interference Screws are intended for use in the following diagnostic indications:

- 1. Tibial and femoral fixation (primary anchorage) of the autologous tendon-transplants as it is used in the reconstruction of the cruciate ligaments of the human knee.
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Acòelly

Division Sign-Off of General Restorat 510(k) Number