STRYKER WEDGE INTERFERENCE SCREW SYSTEM by Stryker Endoscopy

The Stryker Wedge 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 femoral and tibial bony attachments of the patella bone-patellar tendon-tibial bone graft complex, the semi-membranosus tendon grafts, and the semi-tendinosus tendon grafts, or fixation of the allograft techniques such as ACL allografts and Achilles tendon allografts.

Device Description

The Stryker Wedge Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament deficient knee to provide interference fixation of the femoral and tibial bony attachments of the patellar tendon-tibial bone graft complex, the semi-membranosus tendon grafts, and the semi-tendinosus tendon grafts, or fixation of the allograft techniques such as ACL allografts and Achilles tendon allografts. The Stryker Wedge Interference Screw System will be provided sterile for single-use applications (ASTM 4169). This device is validated for EtO (AAMI ST27) and gamma (AAMI ST32) sterilization methods, as well as autoclave steam sterilization for re-sterilization (AAMI ST37 and SSSA), with a minimum SAL of 10-0. The material of construction (ASTM F136) and its overall design are equivalent to currently marketed products. The device material has been found to be biocompatible per ASTM F136, ISO-10993, and G95-1 standards.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the Stryker Wedge Interference Screw System. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than presenting a performance study with acceptance criteria in the way a novel AI/software device would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set size) are not applicable to this type of regulatory submission for a physical orthopedic implant.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance for Stryker Wedge Interference Screw System

Context: The Stryker Wedge Interference Screw System is a physical orthopedic implant intended for ACL reconstruction. Its approval is based on demonstrating substantial equivalence to existing, legally marketed predicate devices, not on meeting specific, quantifiable performance metrics from a novel clinical study as would be seen for an AI or software-as-a-medical-device (SaMD).

Acceptance Criteria Category	Description (as applicable to a 510(k) for an implant)	Reported Device Performance/Evidence
1. Acceptance Criteria	The primary acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to an existing predicate device regarding intended use, safety, and effectiveness. This involves showing that the new device is as safe and effective as the predicate, and does not raise new questions of safety or effectiveness.	The summary states: "The Stryker Wedge Interference Screw System is equivalent in intended use, safety and effectiveness to other fixation devices in commercial distribution." and "The screw system does not raise any new safety and efficacy concerns when compared to other devices currently on the market. Therefore, the Stryker Wedge Interference Screw System is substantially equivalent to other ACL fixation devices." The FDA concurred with this assessment.
2. Device Intended Use	The device must be intended for the same fundamental use as the predicate device(s).	Intended Use: "The Stryker Wedge 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 femoral and tibial bony attachments of the patella bone-patellar tendon-tibial bone graft complex, the semi-membranosus tendon grafts, and the semi-tendinosus tendon grafts, or fixation of the allograft techniques such as ACL allografts and Achilles tendon allografts." This use is consistent with existing ACL fixation devices.
3. Device Materials	Materials of construction must be safe, biocompatible, and either identical or equivalent to those in legally marketed predicate devices.	"The material of construction (ASTM F136) and its overall design are equivalent to currently marketed products. The device material has been found to be biocompatible per ASTM F136, ISO-10993, and G95-1 standards." This indicates that the materials meet established standards for medical implants and are similar to those used in predicate devices.
4. Sterilization	The device must be provided sterile (or sterilizable by the user) and validated to achieve appropriate sterility assurance levels (SAL).	"The Stryker Wedge Interference Screw System will be provided sterile for single-use applications (ASTM 4169). This device is validated for EtO (AAMI ST27) and gamma (AAMI ST32) sterilization methods, as well as autoclave steam sterilization for re-sterilization (AAMI ST37 and SSSA), with a minimum SAL of 10-0." This confirms proper sterilization validation.
5. Biocompatibility	The materials must be demonstrated to be biocompatible.	"The device material has been found to be biocompatible per ASTM F136, ISO-10993, and G95-1 standards."
6. Labeling/Regulatory Compliance	Labeling must be accurate, compliant with FDA regulations, and include appropriate warnings. The device must comply with general controls (e.g., GMP).	FDA letter outlines specific labeling requirements: prominent statement of intended use, prohibition against promoting for pedicular screw fixation, and a warning if screws meet certain size criteria regarding pedicular use. A substantial equivalence finding assumes compliance with Good Manufacturing Practice (GMP) requirements.

Remaining Requested Information (Not Applicable for this 510(k) Device)

The following information pertains to clinical or performance studies that generate quantified metrics, often used for AI/SaMD or higher-risk devices requiring PMA. This 510(k) submission for a physical orthopedic screw system does not involve such studies.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document does not describe a clinical test set or data provenance for performance evaluation in the context of an AI/software device. The submission relies on equivalence to predicate devices, not de novo clinical data comparing the device itself against a specific outcome measure in human subjects for performance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. There was no "ground truth" derived by experts for a test set in the context of a performance study for this device. The assessment was a regulatory review of equivalence.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or related adjudication method was used for performance assessment.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a physical implant, not an AI or imaging device involving human readers or interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical implant; there is no algorithm or standalone performance in the context of AI/software.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No explicit "ground truth" was established for performance metrics in the way it is for an AI/software device. The "truth" for this submission is based on the safety and effectiveness profile of the predicate devices and the physical/biocompatibility characteristics of the new device.

7. The sample size for the training set

Not Applicable. There is no training set for an AI/software model.

8. How the ground truth for the training set was established

Not Applicable. No training set exists for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the Stryker Endoscopy logo. The word "stryker" is in a bold, sans-serif font, with the "s" and "t" connected. There is a registered trademark symbol to the right of the "r". Below "stryker" is the word "ENDOSCOPY" in a smaller, sans-serif font.

K9 7 2233

AUG - 5 1997

DISPOSABLES GROUP

Doug Lorang, M.S.E.

2590 Walsh Avenue Santa Clara, CA 95054 Phone: (408) 567-9100 x2541 Fax: (408) 567-2507

SUMMARY OF SAFETY AND EFFECTIVENESS

Device Name:

Classification Name:	Smooth or Threaded Metallic Bone Fixation FastenersCFR 888.3040, Class II
Device Product Code:	Panel Code 87, Orthopedic Devices, HWC
Common and Usual Name:	ACL Interference Screw
Proprietary Name:	Stryker Wedge 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 Wedge Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament deficient knee to provide interference fixation of the femoral and tibial bony attachments of the patellar tendon-tibial bone graft complex, the semi-membranosus tendon grafts, and the semi-tendinosus tendon grafts, or fixation of the allograft techniques such as ACL allografts and Achilles tendon allografts. The Stryker Wedge Interference Screw System is equivalent in intended use, safety and effectiveness to other fixation devices in commercial distribution. The Stryker Wedge Interference Screw System will be provided sterile for single-use applications (ASTM 4169). This device is validated for EtO (AAMI ST27) and gamma (AAMI ST32) sterilization methods, as well as autoclave steam sterilization for re-sterilization (AAMI ST37 and SSSA), with a minimum SAL of 10-0. The material of construction (ASTM F136) and its overall design are equivalent to currently marketed products. The device material has been found to be biocompatible per ASTM F136, ISO-10993, and G95-1 standards.

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

Douglas M. Lorang, M.S.E. Design Engineer

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's wings and body are formed by the silhouettes of the human faces.

Ford and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Douglas M. Lorang, M.S.E. Design Enqineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95054

AUG - 5 1997

Re : K972233 Stryker Wedge Interference Trade Name: Screw System Requlatory Class: II Product Code: HWC Dated: June 12, 1997 Received: June 16, 1997

Dear Mr. Lorang:

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 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of This device, if intended for use in pedicular screw the Act. fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

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Page 2 - Douglas M. Lorang, M.S.E.

1. The package insert must prominently state that the device is intended for the specific use(s) described in the enclosure only; and
1. You may not label or in any way promote this device for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, "WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a siqnificant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.

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 requlation (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.

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Page 3 - Douglas M. Lorang, M.S.E.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

-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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Page 1

510(k) Number (if known): K972233

Device Name: Stryker Wedge Interference Screw System . .

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K972

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use_

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.