STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM

K993166 · Stryker Endoscopy · HWC · Aug 4, 2000 · Orthopedic

Device Facts

• Record ID: K993166
• Device Name: STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
• Applicant: Stryker Endoscopy
• Product Code: HWC · Orthopedic
• Decision Date: Aug 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.

Device Story

The Stryker Bioabsorbable Interference Screw System is a sterile, single-use orthopedic fixation device used during ACL reconstruction surgery. It provides interference fixation for various allografts and autografts within the knee. The screw is cannulated, features a tapered wedge geometry, a rounded head, and a non-symmetric, buttress-shaped spiral thread. It is manufactured from Poly(L-lactic Acid) (PLLA). The device is implanted by an orthopedic surgeon in an operating room setting. By securing the graft within the bone tunnel, the screw facilitates ligament healing and stabilization. The device is biocompatible and designed to be absorbed by the body over time, eliminating the need for secondary removal surgery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing, material biocompatibility (ISO-10993, G95-1), and design comparison to legally marketed predicate devices.

Technological Characteristics

Material: Poly(L-lactic Acid) (PLLA). Dimensions: 6mm-11mm diameter, 20mm-35mm length. Design: Cannulated, tapered wedge, rounded head, non-symmetric buttress-shaped spiral thread. Sterilization: Gamma irradiation (EN 552) or Ethylene oxide (EN 550) to SAL 10^-6. Biocompatibility: ISO-10993, G95-1. Shelf life: 24 months.

Indications for Use

Indicated for patients undergoing surgical reconstruction of an ACL-deficient knee requiring interference fixation of allografts or autografts (patellar bone-tendon-bone, 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

• Linvatec BioScrew (K973758)
• Stryker Wedge Interference Screw (K972233)

Submission Summary (Full Text)

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AUG 4 2000

Image /page/0/Picture/2 description: The image shows the logo for Stryker Endoscopy. The word "Stryker" is in a bold, sans-serif font, with the letters slightly overlapping. Above the "r" in Stryker is a registered trademark symbol. Below Stryker is the word "ENDOSCOPY" in a smaller, sans-serif font.

2590 Walsh Avenue. Santa

[phone]

# SUMMARY OF SAFETY AND EFFECTIVENESS

#### Device Name:

| Classification Name: | Screw, Fixation, Bone, under 21 CFR, 888.3040 |
|------------------------|-------------------------------------------------|
| Device Product Code: | 87 HWC and MAI |
| Common and Usual Name: | Interference Screw |
| Proprietary Name: | Stryker Bioabsorbable Interference Screw System |

### Regulatory Classification: Class II

#### Safety and Effectiveness Summary:

This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.

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 allografts and autografts, 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 Stryker Bioabsorbable Interference Screw System will be provided sterile for single-use applications (ASTM 4169). This device will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550) and validated to a sterility assurance level (SAL) of 10 . The device is biocompatible per ISO-10993 and G95-1. The Stryker Bioabsorbable Interference Screw System is equivalent in intended use, safety and effectiveness to other fixation devices in commercial distribution. The material of construction and its overall design are equivalent to currently marketed products.

The Stryker Bioabsorbable Screw is substantially equivalent to the Linvatec BioScrew (510(k) K973758 ) in the following fields:

- · Intended use
- · Material
- · Thread design
- · Head design
- · Shelf life

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The Stryker Bioabsorbable Screw is substantially equivalent to the Stryker Wedge Interference Screw (510(k) K972233 ) in the following fields:

- · Intended use
- · Geometry
- · Thread design
- · Head design

Specific similarities/dissimilarities to the predicates are shown in Table 1 and Table 2.

## Table 1: Comparison of Stryker Bioabsorbable Interference Screw to Linvatec BioScrew and Stryker Wedge Screw

| Name | Device Name | Indication for Use | Material | Sterility | Method of Sterilization | Shelf Life |
|----------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------|----------------------------------------------------------------------------------------------------|------------|
| New<br>Product | Bioabsorbable<br>Interference Screw | Intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. | Poly(L-lactic<br>Acid) | Sterile<br>Single-use | Ethylene Oxide<br>or<br>Gamma<br>Radiation<br>(pending post-prototype<br>sterilization<br>testing) | 24 months |
| Predicate | BioScrew<br>Absorbable<br>Interference Screw<br>(K973758) | Provide interference fixation:<br>Patellar bone-tendon-bone grafts in ACL reconstruction<br>Femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft.<br>PCL reconstruction | Poly(L-lactic<br>Acid) | Sterile<br>Single-use | Ethylene Oxide | 24 months |
| Predicate | Wedge Interference<br>Screw<br>(K972233) | Intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft | Titanium<br>(Ti 6Al 4V) | Sterile<br>Single-use | Ethylene Oxide<br>and<br>Gamma<br>Radiation | 5 years |
| Stryker | | | | | | |
| Linvatec | | | | | | |
| Stryker | | | | | | |

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| New<br>Product<br>Stryker | Bioabsorbable<br>Interference<br>Screw | Diameter:<br>6mm-11mm<br>Length:<br>20mm-35mm | Tapered Wedge | Cannulated | Rounded Head | non-<br>symmetric,<br>buttress-<br>shaped thread | spiral<br>thread |
|---------------------------|--------------------------------------------------------------|-----------------------------------------------|---------------|---------------------------|-------------------------------------|--------------------------------------------------|------------------|
| Predicate<br>Linvatec | BioScrew<br>Absorbable<br>Interference<br>Screw<br>(K973758) | Diameter:<br>7mm-11mm<br>Length:<br>20mm-30mm | Cylindrical | Cannulated | Rounded Head<br>&<br>Fully Threaded | non-<br>symmetric,<br>buttress-<br>shaped thread | spiral<br>thread |
| Predicate<br>Stryker | Wedge<br>Interference<br>Screw<br>(K972233) | Diameter:<br>7mm-10mm<br>Length:<br>20mm-35mm | Tapered Wedge | Cannulated<br>or<br>Solid | Rounded Head | non-<br>symmetric,<br>buttress-<br>shaped thread | spiral<br>thread |

# Table 2: Comparison of Stryker Bioabsorbable Interference Screw to Linvatec BioScrew and Stryker Wedge Screw

The screw system does not raise any new safety and efficacy concerns when compared to other devices currently on the market. Therefore, the Stryker Bioabsorbable Interference Screw System is substantially equivalent to other ACL fixation devices.

Jodd Miller

Todd Miller, M.S.E. Design Engineer

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 8 2000

Mr. Todd Miller Stryker Endoscopy In corporated 2590 Walsh Avenue Santa Clara, California 95051

Re: K993166 Trade Name: Stryker Bioabsorbable Interference Screw Regulatory Class: II Product Code: HWC, MAI Dated: May 1, 2000 Received: May 11, 2000

Dear Mr. Miller:

This letter corrects the Indications For Use Enclosure included within our substantially equivalent letter of August 4, 2000 which incorrectly referenced your device as the "Stryker Wedge Suture Anchor System." This letter includes a corrected Indication for Use Form that correctly refers to your device as the "Stryker Bioabsorbable Interference Screw."

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 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). 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 Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Fedcral Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under scctions 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2 - Mr. Todd Miller

This letter will allow you to continue 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 the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

e P. Vochner.

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

510(k) Number (if known): __ ڪ 9 9 31 (6 6)

Device Name: Stryker Bioabsorbable Interference Screw

Indications For Use:

Intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Demme R. Lochner.
(Division Sign-Off)

Division of General Restor... Devices
510(k) Number K993166

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, placed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 4 2000 AUG

Mr. Todd Miller Stryker Endoscopy Incorporated 2590 Walsh Avenue Santa Clara, California 95051

Re: K993166 Trade Name: Stryker Bioabsorbable Interference Screw Regulatory Class: II Product Code: HWC, MAI Dated: May 1, 2000 Received: May 11, 2000

Dear Mr. Miller:

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.

{7}------------------------------------------------

Page 2 - Mr. Todd Miller

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice in your devices), please contact the Office of Compliance at
additionally 809.10 for in vitto diagnostic devices), please contact the Office of additionally 809.10 for in the daguestic on the promotion and advertising of your device, [phone]. Additionally, for questions on the promons in iso, please note the regulation
please contact the Office of Compliance at [phone]. Also, please note t please contact the Office of Compilance at (301) - 1037 - 1037 - 1037 - 1031 - 101.97). Other general
entitled, "Misbranding by reference to premarks obteined from the Divis entitled, "Misbranding by reference io premation of size drom the Division of Small
information on your responsibilities under the Act may be obtains of Small information on your responsionines under [phone] or at [phone], or at its
Manufacturers Assistance at its toll-free 111 Manufacturers Fribibianssww.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Danne 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