← Product Code [HWC](/productcode/HWC) · K965073

# 9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW (K965073)

_Smith & Nephew, Inc. · HWC · Feb 27, 1997 · Orthopedic · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K965073

## Device Facts

- **Applicant:** Smith & Nephew, Inc.
- **Product Code:** [HWC](/productcode/HWC.md)
- **Decision Date:** Feb 27, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Indications for Use

The 9 x 25mm S.I.S. ACL Fixation Screw for Tibial Fixation of Hamstring Tendons Grafts functions the same as the Smith & Nephew RCI ACL Fixation screw for Hamstring Tendons Graft Fixation in the Tibial Tunnel.

## Device Story

9 x 25mm S.I.S. ACL Fixation Screw; used for tibial fixation of hamstring tendon grafts in ACL reconstruction. Device functions as mechanical anchor within tibial tunnel. Operated by orthopedic surgeons in surgical setting. Provides graft stability during healing process.

## Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and functional comparison to predicate devices.

## Technological Characteristics

Material: Implant grade titanium (Ti6Al4V per ASTM F136). Form factor: 9 x 25mm screw. Mechanical fixation device.

## Regulatory 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

- Arthrex Inc. Cannulated Sheathed Interference Screw
- Concept, Inc. Cannulated Conical Tip Interference Screw
- Depuy Kurosaka Fixation Screw
- Smith & Nephew RCI ACL Fixation Screw

## Submission Summary (Full Text)

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FEB 27 1997

Smith & Nephew DonJoy Inc.
2777 Loker Avenue West
Carlsbad, CA 92008-6601 U.S.A.
Telephone: (619) 438-9091
Toll-free: (800) 336-5690
Telefax: (619) 438-3210

Smith & Nephew

K965073

Q. SUMMARY OF SAFETY AND EFFECTIVENESS

The 9 x 25mm S.I.S. ACL Fixation Screw is substantially equivalent to the Arthrex Inc. Cannulated Sheathed Interference Screw, the Concept, Inc. Cannulated Conical Tip Interference Screw, the Depuy Kurosaka Fixation Screw, and the Smith & Nephew RCI ACL Fixation Screw with regard to basic design, intended use, material, and size. The screws are made from implant grade titanium (T16A14V ASTM F136) which is a well know and accepted material for implantable devices. The 9 x 25mm S.I.S. ACL Fixation Screw for Tibial Fixation of Hamstring Tendons Grafts functions the same as the Smith & Nephew RCI ACL Fixation screw for Hamstring Tendons Graft Fixation in the Tibial Tunnel.

Smith & Nephew, Inc.
DonJoy Division

Dan W. Miller
Director, Regulatory Affairs &
Quality Assurance

DUNJOY.

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**Source:** [https://fda-staging.innolitics.com/device/K965073](https://fda-staging.innolitics.com/device/K965073)

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