← Product Code [JEY](/productcode/JEY) · K961976

# THE BIOPLATE FIXATION SYSTEM (K961976)

_Biomedics · JEY · Aug 16, 1996 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K961976

## Device Facts

- **Applicant:** Biomedics
- **Product Code:** [JEY](/productcode/JEY.md)
- **Decision Date:** Aug 16, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4760
- **Device Class:** Class 2
- **Review Panel:** Dental

## Device Story

Bioplate Fixation System consists of plates and screws for surgical fixation. Manufactured from commercially pure titanium and titanium 6Al-4V ELI alloy. Used for implantation purposes; intended for bone fixation applications. Operates as mechanical hardware for stabilization.

## Clinical Evidence

No clinical data; reliance on established material safety and design equivalence to predicate devices.

## Technological Characteristics

Materials: Commercially pure titanium and titanium 6Al-4V ELI alloy. Form factor: Plates and screws for bone fixation. Mechanical fixation principle. Materials comply with established standards for implantation (21 CFR 888.3030).

## Regulatory Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

## Predicate Devices

- Howmedica fixation devices
- Medicon, Inc. fixation devices
- KLS fixation devices
- W.L. Lorenz fixation devices

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

K961976

AUG 16 1996

BIOMEDICS, INC.
536 South Rimpau Boulevard
Los Angeles, California 90020-4832
Tel: (213) 934-4700, FAX: (213) 934-8212

# Summary of Safety and Effectiveness

This statement regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The Bioplate Fixation System is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.)

The plates are substantially equivalent in construction and design to the predicate devices manufactured by Howmedica, Medicon, Inc., KLS and W.L. Lorenz. The screws are manufactured of a titanium alloy that is substantially equivalent in design to the predicate devices.

---

**Source:** [https://fda-staging.innolitics.com/device/K961976](https://fda-staging.innolitics.com/device/K961976)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com