SMALL TITANIUM WRIST FUSION PLATE

K023879 · Synthes (Usa) · HRS · Feb 5, 2003 · Orthopedic

Device Facts

• Record ID: K023879
• Device Name: SMALL TITANIUM WRIST FUSION PLATE
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Feb 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Synthes (USA) Small Titanium Wrist Fusion Plate is intended for use in plate fixation for wrist arthrodesis in patients with disorders such as cerebral palsy, brachial plexopathy, spinal cord injuries, and trauma. This plate addresses the smaller stature and pediatric patient by having a low profile construct and utilizing small screws.

Device Story

Small Titanium Wrist Fusion Plate; low-profile metallic bone fixation device. Used for wrist arthrodesis; designed for smaller stature and pediatric patients. Features 2.1 mm thickness, 107 mm length, 8 holes, and limited contact undercuts to minimize bone contact and soft tissue irritation. Utilizes 2.7 mm and 2.4 mm screws. Implanted by surgeons to stabilize wrist joints in patients with specific neurological or traumatic conditions.

Technological Characteristics

Material: CP Titanium. Form factor: Low-profile plate, 2.1 mm thick, 107 mm length, 8 holes. Features: Limited contact undercuts, tapered ends. Fixation: 2.7 mm and 2.4 mm screws. Class II, 21 CFR 888.3030.

Indications for Use

Indicated for wrist arthrodesis in patients, including pediatric and smaller stature individuals, with disorders such as cerebral palsy, brachial plexopathy, spinal cord injuries, and trauma.

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
• Biomet® Colles Fracture Plate

Submission Summary (Full Text)

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K023879

## FEB 0 5 2003

.

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

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Lisa M. Boyle |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Small Titanium Wrist Fusion Plate |
| CLASSIFICATION: | Class II, § 888.3030 - Single / multiple component metallic bone fixation<br>appliance and accessories |
| PREDICATE DEVICE: | <ul><li>Synthes Straight Wrist Fusion Plate</li><li>Biomet® Colles Fracture Plate</li></ul> |
| DEVICE DESCRIPTION: | The Synthes small titanium wrist fusion plate is a low profile plate with a<br>2.1 mm thickness, a proximal width of 8mm and a distal width of 6 mm.<br>The plate uses a total of 8 holes across the 107 mm pre-contoured length.<br>There are proximal and distal holes which utilizes 2.7 mm and 2.4mm<br>screws. Limited contact undercuts are included to minimize plate to bone<br>contact and the ends are tapered in thickness for minimal soft tissue<br>irritation. |
| INTENDED USE: | The Synthes (USA) Small Titanium Wrist Fusion Plate is intended for use<br>in plate fixation for wrist arthrodesis in patients with disorders such as<br>cerebral palsy, brachial plexopathy, spinal cord injuries, and trauma. This<br>plate addresses the smaller stature and pediatric patient by having a low<br>profile construct and utilizing small screws. |
| MATERIAL: | CP Titanium |

Confidential

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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 features a stylized eagle with three wing segments, representing health, services, and people. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2003

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) P. O. Box 1766 1690 Russell Road Paoli. Pennsylvania 19301

Re: K023879

Trade/Device Name: Synthes Small Titanium Wrist Fusion Plate Regulation Numbers: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: November 18, 2002 Received: November 21, 2002

Dear Ms. Boyle:

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

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Page 2 - Ms. Lisa M. Boyle

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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). 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/dsma/dsmamain.html

Sincerely yours,

Mark N Millman

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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## 2.0 Indications for Use Statement

Page 1 of 1

| 510(k) Number (if known): | K023879 |
|---------------------------|-------------------------------------------------|
| Device Name: | Synthes (USA) Small Titanium Wrist Fusion Plate |

Indications/Contraindications:

The Synthes (USA) Small Titanium Wrist Fusion Plate is intended for use in plate fixation for wrist arthrodesis in patients with disorders such as cerebral palsy, brachial plexopathy, spinal cord injuries, and trauma. This plate addresses the smaller stature and pediatric patient by having a low profile construct and utilizing small screws.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_

for Mark N Milkeran
(Division Sign-Off)

K023879

Confidential