ALTA FULLY THREADED CROSS-LOCKING SCREWS

K963398 · Howmedica Corp. · HWC · Oct 10, 1996 · Orthopedic

Device Facts

• Record ID: K963398
• Device Name: ALTA FULLY THREADED CROSS-LOCKING SCREWS
• Applicant: Howmedica Corp.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• 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.

Indications for Use

Indicated for use with Alta® Femoral and Alta® Tibial/Humeral Intramedullary Rod Systems to lock IM rods in position within the femoral canal.

Regulatory Classification

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, K922266)
• Alta® CFx Reconstruction Rod System (K926232, K935295, K960524)
• Alta® Tibial/Humeral IM Rod System (K884500, K890936, K954554)
• Biomet Uniflex Tibial Nail System
• Biomet Retrograde Femoral Nail System
• Zimmer ZMS Intramedullary Recon Nail

Submission Summary (Full Text)

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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: [phone]
Fax: [phone]
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.