The Cabling System Trochanteric Hook is made of Ti-6Al-4V. The trochanteric hook is used in conjunction with 2.0mm diameter cobalt chrome cables and cobalt chrome clamps from the Smith & Nephew Orthopaedics Cabling System (K031162). The trochanteric hook features one hook to attach to the trochanter and one hole to allow a cable to be routed through the device. The cable is routed through the hole in the device and around the femur. The cable will be tensioned and secured with a clamp. The hook is designed to prevent proximal migration of the trochanter. The device is intended for single use.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the Cabling System Trochanteric Hook. It focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study or performance testing.

Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from this document, as it is not the purpose of a 510(k) summary to provide such details.

However, I can provide the limited information available:

1. A table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria or report specific device performance metrics. The entire submission is built on the premise of substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance:

Not applicable. This 510(k) submission does not describe a clinical or performance testing study involving a "test set" in the context of device performance evaluation. It relies on a comparison to predicate devices, which means prior data and established use were considered.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As no new testing study is described, there is no "test set" and no experts establishing ground truth for performance.

4. Adjudication method for the test set:

Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a mechanical surgical hook, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical surgical implant, not an algorithm.

7. The type of ground truth used:

Not applicable in the context of a new performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices to which the new device is compared for substantial equivalence.

8. The sample size for the training set:

Not applicable. This document does not describe a training set for an algorithm or a device.

9. How the ground truth for the training set was established:
Not applicable.

Summary

{0}------------------------------------------------

K043252 (ps 10f2 JAN 1 4 2005 510(K) SUMMARY CABLING SYSTEM TROCHANTERIC HOOK

SUBMITTER'S NAME: SUBMITTER'S ADDRESS: SUBMITTER'S TELEPHONE NUMBER: CONTACT PERSON: DATE SUMMARY PREPARED: TRADE OR PROPRIETARY DEVICE NAME: COMMON OR USUAL NAME: CLASSIFICATION NAME:

Smith & Nephew. Inc.. Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901-399-6670 John Reabe November 15, 2004 Cabling System Trochanteric Hook Cabling System Bone fixation cerclage. Single/multiple component metallic bone fixation appliances and accessories. Class II Orthopedic/87

DEVICE CLASS: PANEL CODE:

DEVICE INFORMATION:

INTENDED USE:

Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below.

1. Primary total hip arthroplasty
1. Revision total hip arthroplasty
1. Any procedure using anterolateral or lateral approaches

DEVICE DESCRIPTION:

SUBSTANTIAL EQUIVALENCE INFORMATION:

The Cabling System Trochanteric Hook is similar to the Smith & Nephew Orthopaedic Cabling System Trochanteric Grip (K031162) in that both devices are used with the same cables and clamps for trochanteric reattachment whenever the trochanter is osteotomized. The grips in the predicate system feature two hooks to attach to the trochanter, multiple holes to allow cables to be routed through the grip and clamps to secure the cables. The Cabling System Trochanteric Hook features one hook to attach to the trochanter and one hole to allow a cable to be routed through the device and a clamp to secure the cable.

The Cabling System Trochanteric Hook is similar to the Howmedica Dall-Miles Cable Grip (K984432), Pioneer System Greater Trochanteric Reattachment Device (K961267) and the Biomet BMP Cable System (K982545) in that all devices are used with cables and clamps for trochanteric reattachment whenever the trochanter is osteotomized.

The Cabling System Trochanteric Hook is similar to the Smith & Nephew Hook Piate in that both devices are used for trochanteric reattachment whenever the trochanter is osteotomized. The trochanteric hook is used with cables and clamps to secure the bone. The hook plate is used in conjunction with screws to secure the device to the bone.

{1}------------------------------------------------

$$\text{אַזען גער געקוייסטייט אַז אַז דער אַז אַז דער אַז אַז אַז אַז אַז אַז אַז אַז אַז אַז אַז אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַן אַ) אַ{10} 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25$$

The Cabling System Trochantially equivalent to the predicate devices. The differences between the Cabling System Trochanteric Hook and predicate devices. "The safety and effectiveness.

SUMMARY OF TECHNOLOGICAL COMPARISON:

The Ilizarov Pulley System is substantially equivalent to the predicate devices listed in the previous section in terms of indications for use and design.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

Public Health Service

JAN 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Reabe Director Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K043252

Trade Name: Cabling System Trochanter Hook Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: November 22, 2004 Received: November 23, 2004

Dear Mr. Reabe:

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.

{3}------------------------------------------------

Page 2 – Mr. John Reabe

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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Mark A Mallmann

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

{4}------------------------------------------------

510(k) number (if known): _

Device Name: Cabling System Trochanteric Hook

Indications for Use:

Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below.

1. Primary total hip arthroplasty
1. Revision total hip arthroplasty
1. Any procedure using anterolateral or lateral approaches

Prescription Use_ X (Per 21 CFR 801.109) OR

Over-the-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milherson

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

510(k) Number K043252

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.