LCP RADIAL HEAD PLATING SYSTEM

K040777 · Synthes (Usa) · HRS · Jun 18, 2004 · Orthopedic

Device Facts

• Record ID: K040777
• Device Name: LCP RADIAL HEAD PLATING SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Jun 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes LCP Radial Head Plating System is indicated for extra-articular and intra-articular fractures of the proximal radius and for multi-fragmented radial neck fractures.

Device Story

Synthes LCP Radial Head Plating System consists of pre-contoured radial head rim and neck plates designed for proximal radius anatomy. Plates feature limited contact, low-profile design with locking combination and round locking holes. System accepts 2.0, 2.4, and 2.7 mm cortex screws and 2.4 mm locking screws. Used by orthopedic surgeons in clinical settings for internal bone fixation. Provides stable fixation for proximal radius fractures, facilitating bone healing and anatomical alignment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

Materials: Stainless steel, CP titanium, and titanium alloy. Design: Pre-contoured, limited contact, low-profile plates. Fixation: Locking combination and round locking holes for 2.0, 2.4, and 2.7 mm cortex screws and 2.4 mm locking screws. Mechanical bone fixation appliance.

Indications for Use

Indicated for patients with extra-articular and intra-articular fractures of the proximal radius and multi-fragmented radial neck fractures.

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 LCP Distal Radius Volar Plate

Submission Summary (Full Text)

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'JUN 1 8 2004

## Summary of Safety and Effectiveness Information [510(k) Summary] 3.0

040777
page 1 of 1

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Lisa M. Boyle |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | LCP Radial Head Plating System |
| CLASSIFICATION: | Class II, 21 CFR 888.3030: Single / Multiple component bone fixation<br>appliances and accessories. |
| PREDICATE DEVICE: | Synthes LCP Distal Radius Volar Plate |
| DEVICE DESCRIPTION: | The Synthes LCP Radial Head Plate System consists of radial head rim and<br>neck plates. The plates are pre-contoured to match the anatomy of the<br>proximal radius with a limited contact low profile design. The plates<br>feature locking combination holes and round locking holes which accept<br>2.0 and 2.4 & 2.7 mm cortex screws, and 2.4 mm locking screws. The<br>System will be available in Stainless Steel, CP Titanium and Titanium<br>Alloy |
| INTENDED USE: | The Synthes LCP Radial Head Plating System is indicated for extra-<br>articular and intra-articular fractures of the proximal radius and for multi-<br>fragmented radial neck fractures. |
| SUBSTANTIAL<br>EQUIVALENCE: | Docmentation is provided which demonstrates that the Synthes LCP Radial<br>Head Plating System is substantially equivalent to other legally marketed<br>devices. |

Confidential

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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 an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 2004

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania

Re: K040777

Trade/Device Name: Synthes (USA) LCP Radial Head Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 25, 2004 Received: March 26, 2004

Dear Ms. Boyle:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 3 rQxy presidentially equivalent (for the indications ferenced above and nave acteringsally marketed predicate devices marketed in interstate for tise stated in the encrosuly to regars the Medical Device Amendments, or to commerce provision to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alla Cosmette Act (110.) market the device, subject to the general controls provisions of the Act. The You may, therefore, market the det res, buyer to the more of the manual registration, listing of general controls provisions of uactice, 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 If your device is classified (see abort) ins. Existing major regulations affecting your device can may be subject to such additional controller Extoning and to 898. In addition, FDA may be found in the Outs oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of a succession of the requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of ally reactal statutes and regulations adminities bot not limited to: registration and listing (21 comply with an the 7te 31equirements,01); good manufacturing practice requirements as set CTN in the quality systems (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Lisa M. Boyle

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manentig your antial equivalence of your device to a legally premarket nothication. The PDA miding of backanda experiend 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 If you desire specific advice for your act [phone]. Also, please note the regulation entitled, contact the Office of Complance at (501) 37 cart 807.97). You may obtain "Misbranding by reference to premanter nouthead in the Act from the Division of Small other general information on your responsion and at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at in the largement html [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A Millerman

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

| Labels | Values |
|---------------------------|----------------------------------------------|
| 510(k) Number (if known): | K040777 |
| Device Name: | Synthes (USA) LCP Radial Head Plating System |

Indications for use:

The Synthes LCP Radial Head Plate System is indicated for extra-articular and intra-articular fractures of The Synthes LCT Radial Hoad Firagmented radial neck fractures.

R. Mark A. Milkerson

ision Sign-O Division of General, Restorative, and Neurological Devices

510(k) Number K040777

Prescription Use
(Per 21 CFR 801.109) X

AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(PI.EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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