The Osse-Lign System is indicated for general orthopedic repairs. This includes such procedures as long bone fractures, bone grafting and reinforcement of bone. This system may also be used for supplementary fixation and reduction with approved bone plates, screws, pins, nails and bone grafting material.

Long Bone Fractures

. Femur fractures
Tibia fractures .
l lumerus fractures l

Joint Fractures

트 Ankle fractures
Knee Fractures 트
Hip Fractures 비
. Shoulder Fractures
Elbow Fractures

Other bone fractures

발 Olecranon
Pelvis fractures .
Patella fractures ■
. Acetabular fractures
Trocanteric reattachment .
Fixation of fractures in conjunction with I/M nailing and plating techniques
Stabilization of cortical onlay strut graft
Temporary reduction techniques for ORIF (Open Reduction Internal Fixation)

Device Description

Metallic Internal Fixation Device

AI/ML Overview

The provided text is a 510(k) summary for the "1.5 mm Osse-Lign Internal Fracture Fixation System," a metallic internal fixation device. This document focuses on the regulatory submission process and the intended use of the device.

Crucially, the document does NOT contain any information about acceptance criteria for device performance or any studies proving the device meets such criteria.

The 510(k) summary's purpose is to demonstrate substantial equivalence to a predicate device, not to provide detailed performance study results against specific acceptance criteria. The text describes the device's classification, intended use, and the FDA's decision to clear it for market based on substantial equivalence.

Therefore, I cannot provide the requested information from the given text.

To address your request, such information would typically be found in detailed study reports, clinical trial summaries, or validation documents submitted as part of the broader 510(k) submission, but these are not present in the provided excerpt.

Summary

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510(K) SUMMARY

Subject 510(k) Number

040199
page 1 of 1

Sponsor

Osseus, IIC

3131 Princeton Pike Bldg 5, Suite 200 Lawrenceville, NJ 08648

Official Contact

Shawn T. Huxel, President/GM 3131 Princeton Pike Bldg 5, Suite 200 Lawrenceville, NJ 08648 Phone - (908) 997-0127 Fax - (908) 842-0347 Mobile - (908) 896-5893

Proprietary Name

Osse-Lign

Common Name

Mctallic Internal Fixation Device

Classification Name and Reference

888.3010 - Bone Fixation Cerclage

Regulatory Class Class II

Device Product Code

(Panel 87) JDQ

Date Prepared

27 January, 2004

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

Mr. Shawn T. Huxel President/General Manager Osseus, LLC 3131 Princeton Pike Building 5, Suite 200 Lawrenceville, New Jersey 08648

Re: K040199

Trade/Device Name: 1.5 mm Osse-Lign Internal Fracture Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: January 27, 2004 Received: January 29, 2004

Dear Mr. Huxel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosurc) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labcling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Shawn T. Huxel

This letter will allow you to begin marketing your device as described in your Section 510(k) The retet notification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated." - results 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), plcase 11 you atent o epocesse an any of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronal 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.

L. Mark N. Millherson

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 Statement

510 (K) NUMBER IF KNOWN: KO401999

DEVICE NAME: 1.5 mm Osse-Lign Internal Fracture Fixation System

Long Bone Fractures

. Femur fractures
Tibia fractures .
l lumerus fractures l

Joint Fractures

트 Ankle fractures
Knee Fractures 트
Hip Fractures 비
. Shoulder Fractures
Elbow Fractures

Other bone fractures

발 Olecranon
Pelvis fractures .
Patella fractures ■
. Acetabular fractures
Trocanteric reattachment .
Fixation of fractures in conjunction with I/M nailing and plating techniques
Stabilization of cortical onlay strut graft
Temporary reduction techniques for ORIF (Open Reduction Internal Fixation)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Over-the-Counter Use __
(Optional Format 1-27-1996) of

(Optional Format 1-2,1996)

Division

Division of General, Restorative,
and Neurological Services

Page 11 of 114

510(k) Nun

K040199

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.