The Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma or for reconstruction or arthrodesis. Burr hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.

Device Description

The Integra Bone Fixation System includes titanium self-tapping and/or self-drilling screws and plates along with instruments for the internal fixation of bone fragments. The fixation screws are supplied in a variety of diameters and lengths designed to fit Integra's various designs of fixation plates and burr hole covers. The Integra Bone Fixation System includes reusable instruments such as screwdrivers, handles and blades, plate holders, drill bits and instrument trays. The single use fixation plates and screws, and the reusable instruments are provided non-sterile and must be sterilized prior to use. The basic design, intended use, materials, and principles of operation of the Integra Bone Fixation System are equivalent to the predicate devices.

AI/ML Overview

This submission for the Integra Bone Fixation System is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than providing a study that establishes acceptance criteria and proves device performance. Therefore, the requested information regarding acceptance criteria, study details, and performance metrics cannot be found in the provided text.

The document states: "The Integra Bone Fixation System is substantially equivalent to other commercially marketed devices and does not raise new issues of safety and effectiveness." This indicates that the regulatory pathway relies on demonstrating similarity to existing, approved devices rather than presenting novel performance data.

Below is a table showing what information would be included in response to your request if it were a performance study, with "Not Provided" filled in based on the current document.

Acceptance Criteria and Device Performance (Not Provided in this 510(k) Document)

Acceptance Criteria	Reported Device Performance
Not Provided	Not Provided

Detailed Study Information (Not Provided in this 510(k) Document)

Sample size used for the test set and the data provenance: Not Provided. This 510(k) submission does not include data from a test set. It relies on demonstrating substantial equivalence to predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Provided. Ground truth establishment is not relevant for this type of 510(k) submission.
Adjudication method for the test set: Not Provided. Adjudication is not relevant for this type of 510(k) submission.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not Provided. This device is a bone fixation system, not an AI-based diagnostic tool. Therefore, an MRMC study and AI assistance metrics are not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not Provided. This device is a bone fixation system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not Provided. Ground truth is not relevant for this type of 510(k) submission.
The sample size for the training set: Not Provided. This submission does not involve machine learning algorithms requiring a training set.
How the ground truth for the training set was established: Not Provided. This submission does not involve machine learning algorithms requiring a training set.

Summary

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Integra LifeSciences Corporation Premarket Notification 510(k) Integra Bone Fixation System

Integra Bone Fixation System

040860
page 1 of 1

510(k) Summary

Submitter's name and address:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536

Contact person and telephone number:

Donna R. Wallace Director Regulatory Affairs (609) 275-0500

Date prepared: April 1, 2004

Name of device:

Proprietary Name: Common Name: Classification Name: Integra Bone Fixation System Bone Fixation Plates and Screws Bone Fixation Plates Bone Fixation Screws Burr Hole Covers

Substantial Equivalence:

The Integra Bone Fixation System is substantially equivalent to the commercially distributed predicate devices, the TiMesh® System, the Centre-Drive Drill-Free™ Screws, and the LEIBINGER® Bone Plates and Bone Screws.

Intended Use:

Device Description:

Conclusion:

The Integra Bone Fixation System is substantially equivalent to other commercially marketed devices and does not raise new issues of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles three curved lines or strokes, possibly representing human figures or abstract shapes. The overall design is simple and clean, with a focus on the text and the central symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2004

Donna R. Wallace, RAC Director, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K040860

Trade/Device Name: Integra Bone Fixation System Trade/Device Name: - mogia Ecoa8.3030, 21 CFR 888.3040, 21 CFR 882.5330 Regulation Nambers: Bir Crisione component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener, Preformed nonalterable cranioplasty plate

Regulatory Class: II Product Codes: HRS, HWC, GXN Dated: April 1, 2004 Received: April 2, 2004

Dear Ms. Wallace:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosule) to regars and ment date of the Medical Device American processed on The Continerec prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic recry there the device, subject to the general controls provisions of the Act. The r ou may, dierolore, manel of the Act include requirements for annual registration, listing of general controls provisioning practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 above) als. Existing major regulations affecting your device can may be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Dri 3 lossants of our device complies with other requirements of the Act that I Dri has made a aoved regulations administered by other Federal agencies. You must or any I cacal statutes and registments, including, but not limited to: registration and listing (21 Comply with an the 7te 31equirements) news 801); good manufacturing practice requirements as set CI It Fut 607); adoning (2 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your antial equivalence of your device to a legally premarket notification: "The Presults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for Jour ac (301) 594-4659. Also, please note the regulation entitled, a Colliact the Office of Compulance in (21CFR Part 807.97). You may obtain Misolanung by Iciercher to premailso nibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark N. Mellekers

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KOH0860

Device Name: Integra Bone Fixation System

Indications For Use:

The Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma, for reconstruction, or arthrodesis. Burr hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milkerson

. Restorative, Division - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

K040860

510(k) Number-

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.