SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)

K982732 · Synthes · HRS · Oct 8, 1998 · Orthopedic

Device Facts

• Record ID: K982732
• Device Name: SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)
• Applicant: Synthes
• Product Code: HRS · Orthopedic
• Decision Date: Oct 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Distal Radius Plate System is intended for fixation of fractures, osteotomies, including carpal fusions involving the distal radius applied to the volar and dorsal aspect.

Device Story

The Synthes Distal Radius Plate System is a surgical fixation system consisting of volar and dorsal plates, 2.4 mm cortex screws, 2.7 mm cortex screws, and 1.8 mm threaded-head buttress pins. The volar plate is T-shaped and precontoured with threaded screw holes; the dorsal plate is Pi-shaped and precontoured with internally threaded screw holes. Both plate versions are available for right and left anatomy and can be cut to size. The system is used by orthopedic surgeons in an operating room setting to stabilize distal radius fractures, osteotomies, or carpal fusions. The surgeon implants the plates and screws to provide rigid fixation, facilitating bone healing and restoring structural integrity to the distal radius.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Stainless steel and titanium alloy. Components: Volar (T-shaped) and dorsal (Pi-shaped) plates, 2.4mm/2.7mm cortex screws, 1.8mm threaded-head buttress pins. Design: Precontoured, cut-to-size, right/left specific. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for fixation of fractures, osteotomies, and carpal fusions involving the distal radius in patients requiring surgical stabilization.

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 Dorsal Distal Radius Plate System (K962616)
• Synthes Ti Alloy Volar Distal Radius Plate System (K963798)

Submission Summary (Full Text)

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Attachment VII:

SUBMITTER

## Summary of Safety and Effectiveness Information [510(k) Summary]

K982732

Synthes (USA) 1690 Russell Road Paoli, PA 19301 [phone]

Contact: Sheri L. Musgnung

COMMON OR USUAL NAME

Screw, Fixation, Bone Plate, Fixation, Bone

DEVICE CLASSIFICATION: Class II, 21 CFR 888.3030; 888:3040

Synthes Dorsal Distal Radius Plate System (K962616) PREDICATE DEVICE: Synthes Ti Alloy Volar Distal Radius Plate System (K963798)

The Distal Radius Plate System consists of volar and dorsal DESCRIPTION: plates, 2.4 mm cortex screws, and 1.8 mm threaded-head buttress The volar plate is T-shaped, precontoured, and has six pins. threaded screw holes. The dorsal plate is shaped like the Greek letter Pi, precontoured, and has six internally threaded screw holes in the head. Both plates are available in right and left versions; accept cortex screws (2.7 mm and 2.4 mm) and 1.8 mm threaded-head buttress pins; and can be cut to size.

Synthes Distal Radius Plate System is intended for fixation of INTENDED USE: fractures, osteotomies, including carpal fusions involving the distal radius applied to the volar and dorsal aspect.

| MATERIAL: | Plates: Stainless Steel and Titanium alloy |
|-----------|--------------------------------------------|
| | Screws: Titanium and Stainless Steel |

Synthes (USA) Distal Radius Plate System 510(k) CONFIDENTIAL

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 8 1998

Ms. Sheri L. Musqnung Requlatory Affairs Specialist Synthes USA 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K982732 Synthes (USA) Distal Radius Plate System Regulatory Class: II Product Codes: HRS and HWC Dated: August 4, 1998 Received: August 5, 1998

Dear Ms. Musgnung:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Sheri L. Musgnung

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference fo
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.0 Indications for Use Statement

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): k982732

Device Name: Synthes (USA) Distal Radius Plate System

Indications For Use:

Synthes Distal Radius Plate System is intended for fixation of fractures, osteotomies, including carpal fusions involving the distal radius applied to the volar and dorsal aspect.

(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 _________________________________________________________________________________________________________________________________________________________

Acsellaz

(Divisi Sign-Off Division of General Restorative Devices 510(k) Number

Synthes (USA) Distal Radius Plate System 510(k) CONFIDENTIAL