The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures of the distal femur, proximal tibia or distal tibia where soft tissue injury precludes the use of other fracture treatments.

The TempFix External Fixation System is intended to be non-weight bearing.

Device Description

The TempFix External Fixation System consists of components that can be assembled to provide multiple degrees of freedom for positioning implantable threaded fixation pins on either side of a fracture or deformity. The unique frame materials provide radiolucent viewing of the fracture and are lightweight for patient comfort. The components are preassembled in kits with three basic frame configurations: a knee frame, a half pin ankle frame and a transfixing pin ankle frame. Each kit is provided in sterile and non-sterile versions.

AI/ML Overview

The provided text describes the TempFix™ External Fixation System, a medical device. Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Stiffness	The TempFix constructs were stiffer than predicate devices (Howmedica Hoffman II, Immedica/Zimmer Transfx).
Load to Failure	The TempFix constructs had a higher load to failure than predicate devices (Howmedica Hoffman II, Immedica/Zimmer Transfx).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the mechanical tests. The data provenance is not specified beyond being "simulated clinical use," implying laboratory testing. The country of origin of the data is not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a mechanical fixation system, and its performance is evaluated through biomechanical testing, not through expert interpretation of medical images or patient outcomes in the test set.

4. Adjudication Method for the Test Set

Not applicable, as the evaluation is based on objective mechanical measurements, not subjective expert judgment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention any MRMC study or the involvement of human readers in assessing the device's performance. The device is a physical fixation system, not an AI or diagnostic tool that would typically involve human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device's mechanical properties. The document states: "When tested to simulate clinical use, the TempFix constructs were stiffer and had a higher load to failure than either the Howmedica Hoffman II constructs or the Immedica / Zimmer Transfx constructs." This describes the device's performance in isolation during simulated use.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation was based on biomechanical measurements (stiffness and load to failure) under simulated clinical use conditions.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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AUG 2 6 2002

510(k) Summary

Name of Sponsor:	DePuy ACE700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910
510(k) Contact:	Cheryl K. HastingsDirector, Regulatory AffairsPhone: (574) 372-7006FAX: (574) 371-4987
Trade Name:	TempFix™ External Fixation System
Common Name:	External Fixation Devices
Classification:	Class II per 21 CFR 888.3030:Multiple component metallic bone fixatioappliances and accessories

87 KTT ; LX T Device Product Codes:

Substantially Equivalent Devices:

Howmedica Osteonics Hoffman II External Fixator	K000957
Immedica Transfx External Fixation System (distributed by Zimmer)	K984357
ACE Medical Company Align Fixator	K936045
ACE Medical Company ACE -Fischer Pins	K875022
ACE Medical Company ACE -Fischer Pins	K875012
ACE Medical Company ACE-DuPont Composite Rings	K955388

Device Description:

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Indications for use:

The TempFix External Fixation System is intended to be non-weight bearing.

Substantial equivalence:

The TempFix External Fixation System is a lightweight external fixation system similar in intended use and design to the Howmedica Osteonics Hoffman II External Fixator, the Immedica Transfx External Fixation System (distributed by Zimmer) and the DePuy ACE Align Fixator. The implantable stainless steel pins are identical to those cleared previously for the ACE-Fischer Fixator with the exception that the TempFix pins will be etched with positioning lines to provide the surgeon a tool for measuring the insertion depth of the pin. The bar assemblies included in each kit and the U-ring included in the ankle transfixing pin kit are manufactured from carbon fiber / resin composite material as previously cleared for the ACE-DuPont Composite Rings. The articulating slide end and articulating clamp ends used in the TempFix System are similar to those cleared for the ACE Align Fixator. When tested to simulate clinical use, the TempFix constructs were stiffer and had a higher load to failure than either the Howmedica Hoffman II constructs or the Immedica / Zimmer Transfx constructs.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Re:

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

AUG 26 2002

Ms. Cheryl Hastings Director, Regulatory Affairs DePuv ACE P. O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

K021933	Trade Name:	TempFix™ External Fixation System
	Regulation Number:	21 CFR 888.3030
	Regulation Name:	Single/multiple component metallic bone fixation appliances andaccessories
	Regulatory Class:	Class II
	Product Code:	KTT, LXT
	Dated:	June 11, 2002
	Received:	June 12, 2002

Dear Ms. Hastings:

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 enclosure) 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, 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 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 does 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 – Ms. Cheryl Hastings

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/dsmamain.html.

Sincerely yours,

Mark A. Milkeus

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

Enclosure

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510(k) Number (if known): K021933

Device Name: TempFix External Fixation System

Indications for Use:

The TempFix External Fixation System is intended to be non-weight bearing.

Concurrence of CDRH, Office of Device Evaluation

Mark N Milken

Division Sign-Off) Division of General, Restorative and Neurological Devices 2021933 510(k) Number -

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

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.