WRIST FUSION PLATE

K052754 · Dvo Extremity Solutions, LLC · LXT · Oct 27, 2005 · Orthopedic

Device Facts

• Record ID: K052754
• Device Name: WRIST FUSION PLATE
• Applicant: Dvo Extremity Solutions, LLC
• Product Code: LXT · Orthopedic
• Decision Date: Oct 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon. 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; turnor resection; and spastic deformities. Single use device for cementless use only.

Device Story

Anatomically contoured bone fixation plate; used for wrist arthrodesis and small long bone fractures (clavicle, olecranon). Device features single row of screw holes; utilizes locking screws and press-fit intramedullary fixation for proximal stem. Operated by orthopedic surgeons in clinical/surgical settings. Provides rigid fixation to stabilize bone segments; facilitates fusion or fracture healing. Benefits patient through restoration of joint stability and pain relief.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Anatomically contoured plates; titanium (ASTM F-136) or stainless steel (ASTM F-138 or ASTM F-2229). Features 2.4mm, 2.7mm, and 3.2mm screw holes; 2.4mm locking screws (6mm-14mm). Includes press-fit intramedullary fixation. Single use; cementless.

Indications for Use

Indicated for patients requiring wrist arthrodesis or treatment of fractures of small long bones (clavicle, olecranon) due to post-traumatic arthritis, rheumatoid deformities, complex carpal instability, post-septic arthritis, severe motion-related wrist pain, brachial plexus nerve palsies, tumor resection, or spastic deformities. For single, cementless use.

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, Wrist Fusion Plates (K000558)

Submission Summary (Full Text)

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K052754

OCT オデ 視聴

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Solutions 720 E. Winona Ave., Warsaw, IN 46580 877-777-9DVO

## 510(k) Summary of Safety and Effectiveness

| SUMMARY PREPARED: | September 28, 2005 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) SPONSOR/APPLICANT: | DVO Extremity Solutions, LLC<br>720 E. Winona Ave., Warsaw, IN 46580 |
| 510(k) PREPARER and<br>CONTACT PERSON: | Dina L. Weissman, J.D.<br>P.O. Box 205, Derby CT 06418<br>Telephone: [phone], Email: [e-mail] |
| TRADE NAME: | Wrist Fusion Plate |
| COMMON NAME: | Plate, Fixation, Bone |
| CLASSIFICATION: | Class II per 21 CFR § 888.3030 Single/multiple component<br>metallic bone fixation appliances and accessories. |
| DEVICE PRODUCT CODE: | 87 LXT |
| PREDICATE DEVICES: | Synthes, Wrist Fusion Plates, K000558, cleared 14 April 2000 |
| DEVICE DESCRIPTION: | These anatomically contoured plates are offered in two lengths<br>(standard or short), manufactured from either titanium (ASTM<br>F-136) or stainless steel (ASTM F-138 or ASTM F-2229). |
| | The plate contains a single row of screw holes (2.4mm, 2.7mm<br>and 3.2mm in diameter) down its length. The locking screws are<br>2.4mm in diameter and vary in length from 6mm to 14mm. The<br>2.7mm and 3.2mm screws were previously cleared. |
| | In addition to the screws, the device utilizes a press fit<br>intramedullary fixation for the proximal stem. |
| INTENDED USE: | For wrist arthrodesis and for fractures of other small long bones<br>such as the clavicle and olecranon. Specific indications include<br>post-traumatic arthritis of the joints of the wrist; rheumatoid<br>wrist deformities requiring restoration; complex carpal<br>instability, post-septic arthritis of the wrist; severe unremitting<br>wrist pain related to motion; brachial plexus nerve palsies;<br>turnor resection; and spastic deformities. Single use device for<br>cementless use only. |
| COMPARISON TO PREDICATES: | The Wrist Fusion Plate is similar to the listed predicate device in<br>intended use, performance characteristics, materials of<br>construction, manufacturing methods and design.<br>Biomechanical comparisons confirm similar mechanical<br>properties. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement around the symbol. The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DVO Extremity Solutions, LLC c/o Dina L. Weissman, J.D. P.O. Box 205 Derby, Connecticut 06418

OCT 2 7 2005

Re: K052754 Trade/Device Name: Wrist Fusion Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: September 28, 2005 Received: September 30, 2005

Dear Ms. Weissman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed 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 for tase stated in the energent date of the enactment date of the Medical Device Amendments, or 10 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). and cosmetic Fee , roo, warket the device, subject to the general controls provisions of the Act. The r ou may, atterest 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 n your de roo such additional controls. Existing major regulations affecting your device can be found in the Codc 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 cquivalence 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 CHR 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 - Dina L. Weissman, J.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and will and 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 If you desire specific acrively of Compliance at [phone]. Also, please note the regulation entitled, Comace the Ories of Cremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Signature

رسم Mark N. Melkerson Acting 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

KOSZ754 510(k) Number (if known): ___

Device Name: Wrist Fusion Plate

Indications for Use:

For wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon Specific indications include post-traumatic arthritis of the joints of the wrist, chevroatoid 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.

This single use device is for cementless use only.

Prescription Use XXXXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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510(k) Number Foss 354