COMPRESSION STAPLE AND SIMPLE STAPLE

K043059 · Wrightmedicaltechnologyinc · JDR · Jan 18, 2005 · Orthopedic

Device Facts

• Record ID: K043059
• Device Name: COMPRESSION STAPLE AND SIMPLE STAPLE
• Applicant: Wrightmedicaltechnologyinc
• Product Code: JDR · Orthopedic
• Decision Date: Jan 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Compression Staple and Simple Staple are indicated for fixation of bone fractures or bone reconstruction.

Device Story

Metallic bone fixation staples used for orthopedic reconstruction and fracture stabilization. Compression Staple features stainless steel construction, 10 size variations, barbs for anti-migration, and diamond-shaped slot for compression. Simple Staple features stainless steel construction and anti-migration barbs. Devices are implanted by surgeons in clinical/OR settings to provide mechanical stability to bone segments during healing. Output is physical fixation of bone; clinical benefit is stabilization of osteotomies and arthrodeses.

Clinical Evidence

No clinical data. Substantial equivalence supported by analysis data and comparison to previously cleared devices.

Technological Characteristics

Materials: Stainless steel. Design: Fixation staples with barbs for anti-migration. Compression Staple includes a diamond-shaped slot for compression. Dimensions: 10 sizes available for Compression Staple. Energy source: None (mechanical).

Indications for Use

Indicated for bone fixation and reconstruction. Compression Staple: LisFranc arthrodesis, metatarsophalangeal arthrodesis, Akin osteotomy, forefoot osteotomies for hallux valgus (Scarf and Chevron), and metatarsocuneiform joint arthrodesis for metatarsus primus varus. Simple Staple: Wedge osteotomy of the first phalanx (Akin) to correct valgus, pronation of the first ray, external rotation, and wind-swept toes.

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.

Submission Summary (Full Text)

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JAN 1 8 2005

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe in accordance with the 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the Compression Staple and Simple Staple.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|---------------------------------------------------|
| Date: | November 4, 2004 |
| Contact Person: | Katie Logerot Regulatory Affairs Specialist II |
| Proprietary Name: | Compression Staple and Simple Staple |
| Common Name: | Fixation Staple |
| Classification Name and Reference: | 21 CFR 888.3030 Staple, Fixation, Bone - Class II |
| Device Product Code and Panel Code: | 21 CFR 888.3030 Staple, Fixation, Bone - Class II |

#### DEVICE INFORMATION

#### A. INTENDED USE

The Compression Staple and Simple Staple are indicated for fixation of bone fractures or bone reconstruction.

### B. DEVICE DESCRIPTION

The design features of the Compression Staple are summarized below:

- Manufactured from stainless steel .
- . 10 sizes
- Barbs to prevent back out .
- Diamond shape slot compression feature ●

The design features of the Simple Staple are summarized below:

- Manufactured from stainless steel �
- Barbs to prevent back out t

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the Compression Staple and Simple Staple are substantially equivalent to previously cleared fixation staples. The safety and

| headquarters<br>Wright Medical Technology, Inc. | 5677 Airline Road Arlington, TN 38002 | 901.867.9971 phone | www.wmt.com | |
|-------------------------------------------------|---------------------------------------|-----------------------------|----------------------------|----|
| international subsidiaries | | | | 22 |
| 011.32.2.378.3905 Belgium | 905.826.1600 Canada | 011.33.1.45.13.24.40 France | 011.49.4161.745130 Germany | |
| 011.39.0250.678.227 Italy | 011.81.3.3538.0474 Japan | 011.44.1483.721.404 UK | | |

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effectiveness of the Compression Staple and Simple are adequatedy supported by the effectiveness of the Compression Blapts and Billproation, and analysis data provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JAN 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Katie Logerot Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

K043059 Re: Trade/Device Name: Compression staple and simple staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: November 4, 2004 Received: November 5, 2004

Dear Ms. Logerot:

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. Katie Logerot

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 may be obtained 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/industry/support/index.html.

Sincerely yours,

Sincerely yours,

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): K643059

Device Name:_Compression Staple and Simple Staple

Indications For Use:

The Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono The Compression Stapic Is mondoe to e as as a netatarsophalangeal arthrodesis, Akin osteotomy, of bl-offical Usteolomics in the forelood first mich of osteotomies for hallux valgus treatment (Scarf and Chevron), and atthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

The Simple Staple is intended to be used for wedge osteotomy of the first phalanx (Akin The Smiple Staple 18 Intendod to be assus in order to correct a remaining valgus or pronation of the first ray, and external rotation, and wind-swept toes.

Prescription Use
yes
(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)

Mark A. Wilkerson

Division of General, Restorative, and Neurological Devices

510(k) Number K043054