The Fixion Dynamic Hip Screw System (Fixion DHS) is intended for use in fixation of fractures in the proximal femur. The Fixion DHS is indicated for use in pertrochanteric, intertrochanteric, and base of femur neck fractures.

The Fixion DHS can be implanted in an open or in a minimally invasive approach.

Device Description

The Fixion DHS System consists of the following components:

Plate a solid, titanium-made, component, incorporating holes for the insertion of the Hip Peg, Locking Pin and Screws. The Plate Body is shaped to comply with the hone curvature and the Barrel is located at 135° - 145° relative to the Plate Body.
Hip Peg a titanium-made tube with a distal expandable section, to enhance the abutment of the Hip Peg inside the femoral head. The expandable body ends with a conical shaped distal end.
Locking Pin a titanium-made pin. It is used to provide additional fixation of the fragment, if needed, and for stabilizing bone fragments in case of torsional instability
Screws titanium screws. Maximum of 3 7 Screws (Plate length dependant) can be used to attach the plate to the bone (the femur shaft) at its distal section.
Instrumentation Set ~ a set of accessories to be used with the Fixion DHS implants. Accessories for both open and minimally invasive surgical approaches are available.
Inflation Device (Pump) - a manual pump used to expand the Hip Peg.

AI/ML Overview

The provided text is a 510(k) summary for the Disc-O-Tech Medical Technologies Ltd. Fixion® Dynamic Hip Screw System (Fixion® DHS). This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the manner requested.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

No acceptance criteria are explicitly stated.
No study proving device performance against acceptance criteria is described. The document refers to standards like ASTM F 382, ASTM F 384, etc., but these are general specifications for metallic bone plates and orthopedic fracture fixation devices, not specific performance metrics or a study demonstrating the Fixion® DHS meets them.
There is no mention of a test set sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, training set details, or how ground truth was established for any performance evaluation.

The 510(k) summary focuses on:

Predicate Devices: Listing devices to which the Fixion DHS is claimed to be substantially equivalent.
Performance Standards: Identifying industry standards that the materials and general design specifications refer to, rather than reporting device performance against specific criteria.
Intended Use and System Description: Detailing what the device is for and how it is constructed.
Substantial Equivalence Argument: Stating that the device's characteristics are similar to the predicate devices.

In summary, the provided text does not contain the information necessary to fulfill the request for a table of acceptance criteria and a detailed description of a study proving the device meets those criteria.

Summary

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510(K) Summary

Disc-O-Tech Medical Technologies Ltd. Fixion® Dynamic Hip Screw System (Fixion® DHS)

Company Name

Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzliya srael, 46728

Submitter's Name and Contact Person

Yael Rubin Disc-C)-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzliya Ísrael, 46728 Tel: + 972-9-9511511 Fax: + 972-9-9548939

Date Prepared

April 2003

Trade/Proprietary Name

Fixion® Dynamic Hip Screw System (Fixion® DHS)

Classification Name

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 21 CFR 888.3030 Class II

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'Predicate Devices

Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, D K012967, K023437) by Disc-O-Tech Medical Technologies, Ltd.
K031401 2/2
Gotfried PC.C.P (K983814) by Efratgo.
A Vari-Angle Hip Screw System - VHS (K964880) by Biomet.
ア TK2"M Compression Hip Screw System (K972629) by DePuy ACE
Fixion Interlocking Intramedullary Nailing System (K002873, K013449, K023437) A by Disc-O-Tech Medical Technologies, Ltd.

Performance Standards

The following standards were referred:

A ASTM F 382 - 99: Standard Specification and Test Method for Metallic Bone Plates
ASTM F 384 - 00: Standard Specification and Test Method for Metallic Angled Orthopedic Fracture Fixation Devices
A Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (Draft), ORDB/DGRD/CDRH/FDA, May 1, 1995
ア The Fixion DHS implants are manufactured from Titanium and Titanium alloy, which meet the requirements of ASTM F 1472 - 02, ASTM F 136 - 02, and ASTM F 67 -- 00.
A The Fixion DHS System accessories incorporate surgical grade Stainless Steel (complying with ASTM F 899 - 02, ASTM F 1586 - 95), Silicone and Celeron (complying with ISO 16061).

Intended Use

The Fixion DHS can be implanted in an open or in a minimally invasive approach.

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System Description

The Fixion DHS System consists of the following components:

Plate a solid, titanium-made, component, incorporating holes for the insertion of A the Hip Peg, Locking Pin and Screws. The Plate Body is shaped to comply with the hone curvature and the Barrel is located at 135° - 145° relative to the Plate Body.
Hip Peg a titanium-made tube with a distal expandable section, to enhance the A abutment of the Hip Peg inside the femoral head. The expandable body ends with a conical shaped distal end.
Locking Pin a titanium-made pin. It is used to provide additional fixation of the A fragment, if needed, and for stabilizing bone fragments in case of torsional instability
Screws titanium screws. Maximum of 3 7 Screws (Plate length dependant) can A be used to attach the plate to the bone (the femur shaft) at its distal section.
Instrumentation Set ~ a set of accessories to be used with the Fixion DHS implants. A Accessories for both open and minimally invasive surgical approaches are available.
A Inflation Device (Pump) - a manual pump used to expand the Hip Peg.

Substantial Equivalence

The Fixion DHS intended use, design, matcrials, technological characteristics and principles of operation are substantially equivalent to those of Disc-O-Tech's Fixion Interlocking PF Intramedullary Nailing System (K010988, K012967, K023437) and Fixion Interlocking Intramedullary Nailing System (K002783, K013449, K023437), Gotfied PC.C.P (K983814), Biomet VHS (K964880) and DePuy ACE TK2 Compression Hip Screw System (K972629).

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Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health and Human Services. The logo is a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

AUG - 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Yael Rubin Director of Regulatory Affairs Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzliya Israel, 46728

Re: K031401 Trade/Device Name: Fixion Dynamic Hip Screw System (Fixion DHS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: July 7, 2003 Received: July 9, 2003

Dear Mr. Rubin:

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

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Page 2 - Mr. Yael Rubin

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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), please contact the Office 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 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/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

for Celia 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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Disc-O-Tech Medical Technologies, Ltd. Fixion Dynamic Hip Screw System 510(k)

Indication for Use

510(K) Number (if known):	K031401
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Fixion® Dynamic Hip Screw System (Fixion® DHS) Device Name:

Indication for Use:

The Fixion Dynamic Hip Screw System ("Fixion DHS") is intended for use in fixation of fractures in the proximal femur. The Fixion DHS is indicated for use in pertrochanteric, intert:ochanteric, and base of femur neck fractures.

The Fixion DHS can be implanted in either open or minimal invasive surgical approach.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

P : escription Use (per 21 CFR 801.109)

Over the Counter Use

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031461

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.