← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K961498 # RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.) (K961498) _Howmedica, Inc. · HRS · Feb 6, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K961498 ## Device Facts - **Applicant:** Howmedica, Inc. - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Feb 6, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: (201) 507-7875 Fax: (201) 507-6870 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. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K961498](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K961498) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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