← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K961485 # FOREFOOT RECONSTRUCTION SYSTEM (K961485) _Howmedica Corp. · HRS · Jun 1, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K961485 ## Device Facts - **Applicant:** Howmedica Corp. - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Jun 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The system is intended for use in internal fixation of small bones including the foot, hand, craniofacial skeleton and midface. ## Device Story Forefoot Reconstruction System; series of Ti6Al4V titanium alloy screws; diameters 2.3-3.0 mm; lengths 8-22 mm; fully threaded; self-tapping; internal hex-drive heads. Used for internal fixation of small bones in foot, hand, craniofacial skeleton, and midface. Operated by surgeons in clinical/OR settings to stabilize bone fractures or osteotomies. Provides mechanical fixation to facilitate bone healing. ## Clinical Evidence Bench testing only. ## Technological Characteristics Material: Ti6Al4V titanium alloy. Design: Fully threaded, self-tapping screws with internal hex-drive heads. Dimensions: 2.3-3.0 mm diameter, 8-22 mm length. Mechanical fixation device. ## 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 - Luhr® Fixation System (Howmedica Inc.) - Alta® Modular Trauma Small Bone Plating System (Howmedica Inc.) - Synthes® Small Fragment and Mini Set (Synthes USA) ## 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} JUL _ 1 1986 510(k) SUMMARY R96148S # Device: Forefoot Reconstruction System Proprietary Name: Forefoot Reconstruction System Common Name: Small Bone Screw 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 763EY For information contact: John Dichiara Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201)-507-7386 Fax: (201)-507-6870 The Forefoot Reconstruction System is a series of Ti6Al4V titanium alloy screws 2.3-3.0 mm in diameter and 8-22 mm in length. The system is intended for use in internal fixation of small bones including the foot, hand, craniofacial skeleton and midface. All screws are fully threaded and self-tapping with internal hex-drive 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 Luhr® Fixation System (Howmedica Inc.), the Alta® Modular Trauma Small Bone Plating System (Howmedica Inc.) and the Synthes® Small Fragment and Mini Set (Synthes USA). --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K961485](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K961485) **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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