SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS

K000972 · Synthes (Usa) · LXT · Jun 16, 2000 · Orthopedic

Device Facts

• Record ID: K000972
• Device Name: SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
• Applicant: Synthes (Usa)
• Product Code: LXT · Orthopedic
• Decision Date: Jun 16, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Trochanter Stabilization Plate (TSP) for DHS is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw (DHS) plating system.

Device Story

Synthes Trochanter Stabilization Plate (TSP) is a metallic bone fixation component designed to augment the Dynamic Hip Screw (DHS) plating system. The device features a spoon-shaped proximal section that sits against the greater trochanter and a shaft with screw holes that align with the existing DHS plate. It is secured to the femoral shaft using 4.5 mm cortex screws and incorporates slots for the DHS lag screw and anti-rotational screw. Used by orthopedic surgeons in a clinical/surgical setting, the TSP provides additional stabilization for complex hip fractures. The device is supplied either pre-sterilized via gamma radiation or non-sterile for hospital sterilization. By providing a mechanical buttress to the greater trochanter, the plate assists in maintaining fracture reduction and stability during the healing process.

Clinical Evidence

bench testing only

Technological Characteristics

Metallic bone fixation appliance; spoon-shaped plate geometry; utilizes 4.5 mm cortex screws for femoral shaft fixation; compatible with DHS lag and anti-rotational screws; provided sterile (gamma radiation) or non-sterile.

Indications for Use

Indicated for patients with stable and unstable intertrochanteric, subtrochanteric, pertrochanteric, and basilar neck fractures requiring fixation with the Dynamic Hip Screw (DHS) system.

Regulatory Classification

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.

Predicate Devices

• Synthes (USA) Dynamic Hip Screw (DHS®) plating system

Submission Summary (Full Text)

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#### Summary of Safety and Effectiveness Information: 14.

# 510(k) SUMMARY

| Submitter | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Bonnie Smith<br>[phone] |
| Name of the Device | Synthes (USA)<br>Trochanter Stabilization Plate for DHS® |
| Common or Usual<br>Name | Single/multiple component metallic bone fixation appliance |
| Predicate Device | Synthes (USA)<br>Dynamic Hip Screw (DHS®) plating system |
| Device Description | The Synthes Trochanter Stabilization Plate for DHS is a component of the<br>Synthes DHS System, which fits over the sideplate of the DHS. The<br>spoon-shaped area of the TSP, which is proximal to the shaft, resides<br>along the greater trochanter. Screw holes of the TSP shaft line up with the<br>screw holes of the DHS plate to accept the 4.5 mm cortex screws used for<br>fixation to the femoral shaft. Two screw slots accommodate the DHS lag<br>screw and the anti-rotational screw located proximal to it. Synthes<br>Trochanter Stabilization Plates are provided both pre-sterilized by gamma<br>radiation and nonsterile. |
| Intended Use | The Synthes Trochanter Stabilization Plate (TSP) for DHS is intended to<br>treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric<br>and basilar neck fractures when used in conjunction with the Synthes<br>Dynamic Hip Screw (DHS) plating system. |

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, with flowing lines above them.

Public Health Service

JUN 1 6 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Bonnie J. Smith, RAC Senior Regulatory Affairs Associate SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301

Re: K000972

Trade Name: Synthes Trochanter Stabilization Plate for DHS® Regulatory Class: II Product Code: LXT Dated: March 24, 2000 Received: March 27, 2000

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stared in the encreary to tical Device Amendments, or to devices that have been reclassified in encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, oond 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Frenancer Ipprovide), in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Bonnie J. Smith, RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dune R. Lochner.

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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#### 2. Indications for Use

### Premarket Notification [510(k)]

#### INTENDED USE STATEMENT

510(k) Number (if known):

Device Name:

Indications

Synthes (USA)Trochanter Stabilization Plate for DHS®

Synthes Trochanter Stabilization Plate (TSP) for DHS® is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw System (DHS®).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | 11 | |
|----------------------|----|--|
| (Per 21 CFR 801.109) | | |

OR

Over-The-Counter Use_

Duane R. Lochner

Premarket Notification 510(k): Synthes (USA)Trochanter Stabilization Plate for DHS® CONFIDENTIAL

(Division Sign-Off) Division of General Restorative Devises O O C 510(k) Number 600