← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K963398 # ALTA FULLY THREADED CROSS-LOCKING SCREWS (K963398) _Howmedica Corp. · HWC · Oct 10, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K963398 ## Device Facts - **Applicant:** Howmedica Corp. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Oct 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Alta® Fully Threaded Cross-Locking Screws are intended to be used in conjunction with the Alta® Femoral and Alta® Tibial/Humeral Intramedullary Rod Systems. Specifically, the screws are used to lock the IM rods in position after placement in the femoral canal. ## Device Story Alta® Fully Threaded Cross-Locking Screws; titanium alloy orthopedic fixation hardware. Used as accessory to Alta® Femoral and Alta® Tibial/Humeral Intramedullary Rod Systems. Function: lock IM rods in position within femoral canal post-placement. Operated by orthopedic surgeons in clinical/OR settings. Benefit: provides mechanical stability to intramedullary fixation constructs. ## Clinical Evidence Bench testing only. ## Technological Characteristics Material: Titanium alloy. Diameters: 5.0mm and 3.7mm. Lengths: 25mm to 100mm. Fully threaded design. Mechanical fixation component. ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Alta® Femoral Locking IM Rod System ([K850441](/device/K850441.md), [K922266](/device/K922266.md)) - Alta® CFx Reconstruction Rod System ([K926232](/device/K926232.md), [K935295](/device/K935295.md), [K960524](/device/K960524.md)) - Alta® Tibial/Humeral IM Rod System ([K884500](/device/K884500.md), [K890936](/device/K890936.md), [K954554](/device/K954554.md)) - Biomet Uniflex Tibial Nail System - Biomet Retrograde Femoral Nail System - Zimmer ZMS Intramedullary Recon Nail ## 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} K963398 OCT 10 1996 510(k) Summary Proprietary Name: Alta® Fully Threaded Cross-Locking Screws Common Name: Intramedullary Fixation Rod Classification Name and Reference: 21 CFR 888.3020 Intramedullary Fixation Rod Proposed Regulatory Class: Class II Device Product Code: OR(87) HSB 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: 8/29/96 The Alta® Fully Threaded Cross-Locking Screws are intended to be used in conjunction with the Alta® Femoral and Alta® Tibial/Humeral Intramedullary Rod Systems. Specifically, the screws are used to lock the IM rods in position after placement in the femoral canal. The fully threaded screws are manufactured from a Titanium alloy and are available in 5.0mm and 3.7mm diameters in lengths of 25 to 100mm. The substantial equivalence of these screws is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's Alta® Femoral Locking IM Rod System (K850441 & K922266), Alta® CFx Reconstruction Rod System (K926232, K935295 & K960524), and Alta® Tibial/Humeral IM Rod System (K884500, K890936 & K954554); Biomet's Uniflex Tibial Nail System and Retrograde Femoral Nail System; and Zimmer's ZMS Intramedullary Recon Nail. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K963398](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K963398) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com