MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM

K033252 · Stryker Endoscopy · HWC · Nov 13, 2003 · Orthopedic

Device Facts

• Record ID: K033252
• Device Name: MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
• Applicant: Stryker Endoscopy
• Product Code: HWC · Orthopedic
• Decision Date: Nov 13, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Bioabsorbable Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL autografts and allografts, including the patella bone-patellar tendontibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The device is provided sterile and intended for single-use only.

Device Story

The Stryker Bioabsorbable Interference Screw System is a bone fixation device used in ACL reconstruction surgery. It provides interference fixation for various autografts and allografts within the knee. The device is a single-unit screw manufactured from an absorbable polymer. It is intended for single-use and is provided sterile. Surgeons use the device during orthopedic procedures to secure grafts in place. The device functions by providing mechanical fixation of the graft to the bone. Performance is evaluated through insertion torque and pullout testing. The device is a line extension of an existing system, sharing identical materials and manufacturing processes.

Clinical Evidence

Bench testing only. Performance was evaluated through insertion torque and pullout test results comparing the line extension device to the predicate device.

Technological Characteristics

Material: Absorbable polymer derived from Poly L-lactic acid (ASTM 4169). Form factor: Interference screw (12 x 35 mm). Sterilization: Gamma irradiation (EN 552) or Ethylene oxide (EN 550) to a sterility assurance level (SAL) of 10^-6.

Indications for Use

Indicated for patients undergoing surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee requiring interference fixation of autografts or allografts (patellar tendon-tibial bone complex, semi-tendinosus, semi-membranosus, or Achilles tendon grafts).

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

• Stryker Bioabsorbable Interference Screw System (K993166)

Submission Summary (Full Text)

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NOV 1 3 2003

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# SUMMARY OF SAFETY AND EFFECTIVENESS

### Device Name

Classification Name:

Common and Usual Name: Proprietary Name:

Screw, Fixation, Bone 21 CFR §888.3040, Class II Bioabsorbable Interference Screw Stryker Bioabsorbable Interference Screw System

#### Predicate Device

Stryker Bioabsorbable Interference Screw System, (#K993166), currently marketed by Stryker Endoscopy (San Jose, CA).

#### Summary

The Stryker Bioabsorbable Interference Screw System is for use in surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL autografts and allografts, including the patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The Stryker Bioabsorbable Interference Screw System is made as a single unit from an absorbable polymer derived from Poly L-lactic acid (ASTM 4169). This device will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN 550) including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10°. The material, molding process, sterilization process for the line extension is equivalent to the predicate device, the Stryker Bioabsorbable Interference Screw System.

The Stryker Bioabsorbable Interference Screw System is substantially equivalent in material of construction, overall design, intended use, safety, and efficacy to the Stryker Bioabsorbable Interference Screw System (#K993166) currently in commercial distribution. When comparing insertion torque and pullout test results, the line extension device has substantially equivalent performance to the predicate device, and is considered substantially equivalent to the Stryker Bioabsorbable Interference Screw System.

Contact:

Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 [phone]

October 1, 2003 Date:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

Ms. Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, California 95138

Re: K033252

Trade Name: Stryker Bioabsorbable ACL Screw - Addition of 12 x 35 mm screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: HWC. MAI Dated: October 1, 2003 Received: October 17, 2003

Dear Ms. Murphy:

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.

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Page 2 – Ms. Melissa Murphy

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) 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 (301) 594-_. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Melkerson

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

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October 1, 2003

KO 3 510(k) Number if known: 3 2 5

## INDICATION FOR USE:

The Stryker Bioabsorbable Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL autografts and allografts, including the patella bone-patellar tendontibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The device is provided sterile and intended for single-use only.

R. Mark A. Mulkeran

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K033

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