TITANIUM ALLOY BONE SCREWS

K970549 · Aesculap, Inc. · HWC · Apr 30, 1997 · Orthopedic

Device Facts

• Record ID: K970549
• Device Name: TITANIUM ALLOY BONE SCREWS
• Applicant: Aesculap, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Apr 30, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The titanium alloy cortical bone screws presented in this submission are intended for long and small bone fracture fixation.

Device Story

4.0mm titanium alloy bone screws (partially and fully threaded) with manual orthopedic instruments; used for long and small bone fracture fixation; operated by surgeons in clinical/OR settings; provides mechanical stabilization of bone fragments; benefits include secure fixation of fractures.

Clinical Evidence

Bench testing only; fatigue testing performed on titanium alloy screws. No clinical data provided.

Technological Characteristics

Titanium alloy material; 4.0mm diameter; partially and fully threaded configurations; manual orthopedic instrumentation; manufactured per ISO and German DIN standards.

Indications for Use

Indicated for patients requiring fixation of long and small bone fractures.

Regulatory Classification

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

• Aesculap Titanium Alloy Bone Screws (K970549)
• AME Universal bone screw (K930107)
• Ace Cortical bone screw (K912598)

Submission Summary (Full Text)

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AESCULAP
K970549
510(k) Summary of Safety and Effectiveness
(in Accordance with SMDA of 1990)
APR 30 1997

# Aesculap Titanium Alloy Bone Screws

## Submitted by:
Aesculap®, Inc.
1000 Gateway Blvd.
So. San Francisco, CA 94080

Contact: Victoria Mackinnon
Phone: [phone] x346
FAX: [phone]

## Product Name
Trade Name: Aesculap Titanium Alloy Bone Screws
Common Name: Bone Screws
Classification Name: Screw, Fixation, Bone

## Predicate Device
The titanium alloy bone screws from Aesculap are identified as predicate devices.

## Device Description
The subject of this premarket notification are 4.0mm titanium alloy (partially threaded and fully threaded) bone screws and associated manual orthopedic instruments designed to assist screw fixation.

## Intended Use
The titanium alloy cortical bone screws presented in this submission are intended for long and small bone fracture fixation.

## Summary of Technological Characteristics
Aesculap's Titanium Alloy Bone Screws represent no change in technological characteristics. There have been only minor modifications to product design.

## Performance Data
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, fatigue testing was performed on the titanium alloy screws; this information is detailed in the application. The Titanium Alloy Bone Screws will be manufactured in accordance with ISO and German Din Standards.

1000 GATEWAY BOULEVARD • SOUTH SAN FRANCISCO, CA 94080-7030 • USA • 415-876-7000 • FAX: [phone]
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1000 GATEWAY BOULEVARD • SOUTH SAN FRANCISCO, CA 94080-7030 • USA • 415-876-7000 • FAX: [phone]

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# AESCULAP

## 510(k) Summary of Safety and Effectiveness

Aesculap Titanium Alloy Bone Screws, page 2 of 2.

## Substantial Equivalence

Aesculap believes that the Titanium Alloy Bone Screws presented in this submission are substantially equivalent in design, function, and intended use to Aesculap's current line of bone screws and other existing legally marketed bone screws such as:

- AME Universal bone screw (subject to #K930107) and
- Ace Cortical bone screw (subject to #K912598).