SYNTHES (USA) LCP WRIST FUSION PLATES

K042355 · Synthes (Usa) · HRS · Oct 27, 2004 · Orthopedic

Device Facts

• Record ID: K042355
• Device Name: SYNTHES (USA) LCP WRIST FUSION PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Oct 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes (USA) LCP Wrist Fusion Plates are intended for wrist arthrodesis and fractures of other small bones. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability; post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities.

Device Story

Synthes LCP Wrist Fusion Plates are metallic bone fixation implants designed for wrist arthrodesis and small bone fracture stabilization. Plates feature pre-contoured, limited-contact design; 3.3 mm thickness; 11 mm width; 10 combination holes accommodating 2.7 mm and 3.5 mm cortex and locking screws. Used by orthopedic surgeons in clinical settings to provide rigid fixation for bone fusion or fracture management. Benefits include restoration of joint stability and pain relief in patients with degenerative or traumatic wrist conditions.

Clinical Evidence

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

Technological Characteristics

Metallic bone fixation plate; materials: Titanium and Stainless Steel; dimensions: 3.3 mm thickness, 11 mm width; features 10 combination holes for 2.7 mm and 3.5 mm cortex and locking screws; pre-contoured, limited-contact design.

Indications for Use

Indicated for patients requiring wrist arthrodesis or treatment of small bone fractures, including those with post-traumatic arthritis, rheumatoid deformities, carpal instability, post-septic arthritis, severe motion-related wrist pain, brachial plexus nerve palsies, tumor resection, or spastic deformities.

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 Straight Wrist Fusion Plate, 170 mm

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for SYNTHES. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. There is a registered trademark symbol after the word SYNTHES. A horizontal line is present below the word.

OCT 2 7 2004

K042355

## 3.0 510(k) Summary

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) LCP Wrist Fusion Plates |
| Classification: | Class II, 21 CFR §888.3030<br>Single/multiple component metallic bone fixation appliances and<br>accessories |
| Predicate Device: | Synthes Straight Wrist Fusion Plate, 170 mm |
| Device Description: | The Synthes LCP Wrist Fusion Plates are pre-contoured with a<br>limited contact design utilizing a short bend with a 3.3 mm<br>thickness and a width of 11 mm. The plate uses a total of 10<br>combination holes which utilizes 2.7 mm and 3.5 mm cortex and<br>locking screws. The plates are available in Titanium and Stainless<br>Steel. |
| Intended Use: | Synthes (USA) LCP Wrist Fusion Plates are intended for wrist<br>arthrodesis and fractures of other small bones. Specific indications<br>include post-traumatic arthritis of the joints of the wrist; rheumatoid<br>wrist deformities requiring restoration; complex carpal instability;<br>post-septic arthritis of the wrist; severe unremitting wrist pain related<br>to motion; brachial plexus nerve palsies; tumor resection; and spastic<br>deformities. |
| Substantial<br>Equivalence: | Documentation is provided which demonstrates that Synthes LCP<br>Wrist Fusion Plates are substantially equivalent to other legally<br>marketed Synthes devices. |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, connected and flowing together in a wave-like form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 2004

Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K042355

Trade/Device Name: Synthes (USA) LCP Wrist Fusion Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/ multiple component metallic bone fixation appliances and accessories. Regulatory Class: II Product Code: HRS Dated: August 30, 2004 Received: August 31, 2004

Dear Ms. Musgnung:

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. Sheri L. Musgnung

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Marl A. Millers

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

510(k) Number (if known):

| Device Name: | Synthes (USA) LCP Wrist Fusion Plates |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications: | Synthes (USA) LCP Wrist Fusion Plates are intended for wrist<br>arthrodesis and fractures of other small bones. Specific<br>indications include post-traumatic arthritis of the joints of the<br>wrist; rheumatoid wrist deformities requiring restoration;<br>complex carpal instability; post-septic arthritis of the wrist;<br>severe unremitting wrist pain related to motion; brachial plexus<br>nerve palsies; tumor resection; and spastic deformities. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

l Mal n Mill
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

K042335 510(k) Number_________________________________________________________________________________________________________________________________________________________________

090004