← Product Code [HWE](/submissions/SU/subpart-e%E2%80%94surgical-devices/HWE) · K962913

# SYNTHES STERILE DRILL BITS (K962913)

_Synthes (Usa) · HWE · Nov 14, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWE/K962913

## Device Facts

- **Applicant:** Synthes (Usa)
- **Product Code:** [HWE](/submissions/SU/subpart-e%E2%80%94surgical-devices/HWE.md)
- **Decision Date:** Nov 14, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4820
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Intended Use

Synthes Sterile Drill Bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

## Device Story

Sterile drill bits used by surgeons in clinical/OR settings to create pilot holes in bone; facilitates subsequent insertion of orthopedic fixation hardware (screws, pins, plates, etc.). Device features fluted design; available in solid or cannulated configurations; includes various coupling mechanisms and size options. Provided sterile to user to ensure surgical readiness.

## Clinical Evidence

bench testing only

## Technological Characteristics

Fluted drill bits; solid or cannulated; various lengths/diameters; various coupling mechanisms; gamma radiation sterilization.

## Regulatory Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

## 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.
>
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SYNTHES
K962913

Attachment IV: Summary of Safety and Effectiveness Information

|  Synthes (USA) | (610) 647 - 9700 | NOV 14 1996  |
| --- | --- | --- |
|  1690 Russell Road | Contact: Angela J. Silvestri |   |
|  Paoli, PA 19301 | July 1996 |   |

Synthes commercially available Drill Bits are being made available as sterile.

Synthes Sterile Drill Bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

Synthes Sterile Drill Bits are available in various sizes and lengths, have a fluted design, and are either solid or cannulated, and may be calibrated. The Synthes Sterile Drill Bits have various coupling mechanisms.

Synthes Drill Bits will be provided to the user sterile. Gamma radiation will be used to sterilize the device.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWE/K962913](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWE/K962913)

**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).

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