R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM

K961496 · Howmedica, Inc. · HRS · Jun 28, 1996 · Orthopedic

Device Facts

• Record ID: K961496
• Device Name: R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM
• Applicant: Howmedica, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jun 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The system is intended for use in internal fixation of small bones--primarily the distal radius in the forearm.

Device Story

System consists of titanium plates (T-configurations, varying lengths) and 2.7 mm diameter fully threaded, self-tapping titanium screws with cross-slotted heads; used for internal fixation of small bones, primarily distal radius; operated by orthopedic surgeons in clinical/surgical settings; provides mechanical stabilization of bone fractures to facilitate healing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium bone plates and screws; 2.7 mm diameter screws; fully threaded, self-tapping design; cross-slotted screw heads; mechanical fixation device.

Indications for Use

Indicated for internal fixation of small bones, specifically the distal radius in the forearm.

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

• Alta® Modular Trauma Small Bone Plating System (Howmedica Inc.)
• Synthes® Small Fragment and Mini Set (Synthes USA)

Submission Summary (Full Text)

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K 96 1496

510(k) SUMMARY

JUN 28 1996

# Device: R. R. P. S. Radius Reconstruction Plating System

| Proprietary Name: | R. R. P. S. Radius Reconstruction Plating System |
| --- | --- |
| Common Name: | Small Bone Plating System |
| Classification Name and Reference: | Single/Multiple Component Metallic Bone Fixation Appliances and Accessories 888.3030 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87HRS |
| For information contact: | Frank Maas
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
Telephone: [phone]
Fax: [phone] |

The R. R. P. S. Radius Reconstruction Plating System is a series of titanium plates and screws with plates of T configurations and varying lengths. The system is intended for use in internal fixation of small bones--primarily the distal radius in the forearm. These plates are attached to bone using 2.7 mm diameter titanium bone. All screws are fully threaded and self-tapping with cross-slotted heads.

The substantial equivalence of these devices is based on equivalence in intended use, design, materials and operating principles to several legally marketed devices including the Alta® Modular Trauma Small Bone Plating System (Howmedica Inc.) and the Synthes® Small Fragment and Mini Set (Synthes USA).