RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)

K961498 · Howmedica, Inc. · HRS · Feb 6, 1997 · Orthopedic

Device Facts

• Record ID: K961498
• Device Name: RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)
• Applicant: Howmedica, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Feb 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Resch Fixation Screws are intended to be used for Fractures or Arthrodesis of Carpals and Metacarpals, Radial Head and Radial Styloid Fractures, Metatarsal Fractures and Osteotomies of the Forefoot, and Intra-articular arthrodesis in the wrist.

Device Story

Resch Fixation Screw system; titanium alloy (commercially pure or TMZF) bone screws; 2.7mm diameter; 10mm-40mm lengths; cannulated, fully threaded, self-tapping design; optional washers for osteoporotic bone; used by surgeons for bone fixation/arthrodesis in small bones of hand/foot; provides mechanical stabilization of bone fragments to facilitate healing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Titanium alloy (commercially pure or TMZF); cannulated, fully threaded, self-tapping screw design; 2.7mm diameter; 10-40mm lengths; optional washers.

Indications for Use

Indicated for patients requiring fixation for fractures or arthrodesis of carpals, metacarpals, radial head, radial styloid, metatarsals, forefoot osteotomies, and wrist intra-articular arthrodesis.

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 3.0mm & 3.5mm Cannulated Screw Systems
• Alphatec Mini Lag Screw System
• Howmedica Alta Modular Small Bone Plating System
• Howmedica Cfx Intramedullary Rod and Screw System

Submission Summary (Full Text)

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510(k) Summary

FEB - 6 1997
K961498

Proprietary Name: Resch Fixation Screw

Common Name: Small Bone Screw System

Classification Name and Reference: 21 CFR 888.3030
Single/Multiple Component Metallic Bone Fixation
Appliances and Accessories

Proposed Regulatory Class: Class II
Device Product Code: OR(87) HRS

For information contact:
Frank Maas
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
Telephone: [phone]
Fax: [phone]
Date Summary Prepared: 11-15-96

The Resch Fixation Screw is a series of titanium alloy screws, commercially pure or TMZF alloy, available in a 2.7mm diameter and lengths of 10mm to 40mm. The Resch Fixation Screws are intended to be used for Fractures or Arthrodesis of Carpals and Metacarpals, Radial Head and Radial Styloid Fractures, Metatarsal Fractures and Osteotomies of the Forefoot, and Intra-articular arthrodesis in the wrist. The screws are available with or without washers (used to prevent the head of the screw from sinking into osteoporotic bone), and are cannulated, fully threaded, and self-tapping.

The substantial equivalence of the Resch Fixation Screw is based on an equivalence in design, materials, intended use, and operational principles to Synthes' 3.0mm & 3.5mm Cannulated Screw Systems, Alphatec's Mini Lag Screw System, and Howmedica's Alta Modular Small Bone Plating System and Cfx Intramedullary Rod and Screw System.