← Product Code [HTN](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN) · K963420

# CANCELLOUS SCREW WASHER (K963420)

_Orthopaedic Biosystems, Ltd. · HTN · Nov 15, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN/K963420

## Device Facts

- **Applicant:** Orthopaedic Biosystems, Ltd.
- **Product Code:** [HTN](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN.md)
- **Decision Date:** Nov 15, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3030
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The Cancellous Screw Washers are washers designed for use in conjunction with cancellous bone screws. These implants are intended for fracture fixation of the metatarsals, metacarpals, and tarsal bones.

## Device Story

Cancellous Screw Washer; used as support under bone screw head; provides stability for cancellous bone screws during fracture fixation; indicated for metatarsal, metacarpal, and tarsal bone procedures; used by surgeons in clinical/OR settings; enhances screw fixation; benefits patient by providing structural support to bone fragments.

## Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate.

## Technological Characteristics

Materials: Titanium or Stainless Steel. Form factor: Washer for cancellous bone screws. Function: Mechanical support under screw head.

## Regulatory Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

## Predicate Devices

- Synthes Screw Washer

## Submission Summary (Full Text)

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NOV-13-1996 10:15
ORTHOPAEDIC BIOSYSTEMS
622 336 2102 - .24

Cancellous Screw Washer 510(k)Summary - Safety and Effectiveness K963420

NOV 15 1996

The proposed device, the Cancellous Screw Washer claims substantial equivalence to a currently marketed device, Synthes Screw Washer. The Synthes Screw Washer and the proposed device are available in either Titanium or Stainless Steel. Both function as added support under bone screw head and have no significant design differences. The Cancellous Screw Washers are washers designed for use in conjunction with cancellous bone screws. These implants are intended for fracture fixation of the metatarsals, metacarpals, and tarsal bones.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN/K963420](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN/K963420)

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