BONE FUSION PLATE SYSTEM

K042205 · Wrightmedicaltechnologyinc · HRS · Sep 20, 2004 · Orthopedic

Device Facts

• Record ID: K042205
• Device Name: BONE FUSION PLATE SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRS · Orthopedic
• Decision Date: Sep 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bone Fusion Plate System is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces.

Device Story

Bone fixation system consisting of metallic plates and non-locking cruciform screws; used by orthopedic surgeons for stabilization during first metatarsal-phalangeal joint fusion; device maintains bone position to facilitate bony union; plate acts as secondary load-bearing structure post-fusion; device is implanted surgically.

Clinical Evidence

No clinical data provided; substantial equivalence supported by mechanical analysis and materials information.

Technological Characteristics

Metallic bone fixation plates and screws; non-locking cruciform screw design; available in multiple lengths (8-24mm); left and right configurations.

Indications for Use

Indicated for patients requiring fixation for fractures, osteotomies, or arthrodesis of the first metatarsal-phalangeal joint; hallux valgus deformity; arthritis-related deformity; hallux rigidus (loss of motion); pain from osteoarthritis or rheumatoid arthritis; revision procedures; and chronic instability of the first metatarsal-phalangeal joint.

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

• HALLU® Plate System

Submission Summary (Full Text)

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K04 2205 1/2

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the Bone Fusion Plate System.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------------------|
| Date: | August 12, 2004 |
| Contact Person: | Jeanine H. Redden<br>Regulatory Affairs Specialist II |
| Proprietary Name: | Bone Fusion Plate System |
| Common Name: | Bone Fusion Plate |
| Classification Name and Reference: | 21 CFR 888.3030 Plate, Fixation, Bone – Class II |
| Device Product Code and Panel Code: | Orthopedics/87/HRS |

### DEVICE INFORMATION

#### A. INTENDED USES/ INDICATIONS

The Bone Fusion Plate System is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces.

Indications for Use:

- · Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
- · Deformity due to hallus valgus
- · Deformity due to arthritis in the first metatarsal-phalangeal joint
- Loss of motion- hallux rigidus
- · Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsalphalangeal joint
- · Revision procedures where other treatments or devices have failed; and
- · Chronic instability in the first metatarsal-phalangeal joint

#### B. DEVICE DESCRIPTION

The Bone Fusion Plate System consists of plates, and screws. The design features of the components included in the Bone Fusion Plate System are summarized below:

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K642205 2/2

Bone Fusions Plate

- · Left and Right configurations
- · Available in 2 options

### 2.7mm Cruciform Screws

- · Non-locking
- · Lengths available: 8, 10, 12, 14, 16, 18, 20, 22, 24mm

### 3.2mm Cruciform Screws

- · Non-locking
- · Lengths available: 14, 16, 18, 20, 22, 24mm

#### SUBSTANTIAL EQUIVALENCE INFORMATION C.

The indication for use of the Bone Fusion Plate System is substantially equivalent to the predicate device HALLU® Plate System. The safety and effectiveness of the Bone Fusion Plate System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jeanine H. Redden Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K042205 Trade/Device Name: Bone Fusion Plate 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 12, 2004 Received: August 16, 2004

Dear Ms. Redden:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) fee device is substantially equivalent (for the indications ferenced above and nave cetermined ly marketed predicate devices marketed in interstate for use stated in the encrosure) to regard the Medical Device Amendments, or to commerce price to May 20, 1978, is secordance with the provisions of the Federal Food, Drug, de vices mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercere, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 elaboried (soo as courols. Existing major regulations affecting your device can may be subject to subli additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oban ements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be actives that I Dr researchat at your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cacial statutes and regulations and limited to: registration and listing (21 comply with an the Fee break and 101); good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quant) bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Jeanine H. Redden

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manieting your and equivalence of your device to a legally premarket notheadon: The PDA miaing of castion 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 II you desire specific advice for your ac 11 [phone]. Also, please note the regulation entitled, Condor the Orition of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

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: Bone Fusion Plate

Indications For Use:

The Bone Fusion Plate System is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces.

Indications for Use:

- · Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
- · Deformity due to hallus valgus
- Deformity due to arthritis in the first metatarsal-phalangeal joint
- Loss of motion- hallux rigidus
- · Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsalphalangeal joint
- · Revision procedures where other treatments or devices have failed; and
- · Chronic instability in the first metatarsal-phalangeal joint

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

**510(k) Number** k042265