TBD

K963077 · Acu Med, Inc. · HSB · Oct 1, 1996 · Orthopedic

Device Facts

• Record ID: K963077
• Device Name: TBD
• Applicant: Acu Med, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Oct 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acumed Supracondylar Nail is an intramedullary rod which addresses supracondylar fractures. The nail is used in conjunction with 5 mm interlocking screws.

Device Story

Intramedullary rod for supracondylar fracture fixation; used with 5 mm interlocking screws. Device implanted by orthopedic surgeons in clinical/OR settings. Provides structural stabilization of bone fractures. Benefits include fracture reduction and stabilization.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Intramedullary rod; titanium per ASTM F 136; diameters 11-13 mm; lengths 150-220 mm; gamma radiation sterilization (10⁻⁶ SAL).

Indications for Use

Indicated for patients with supracondylar fractures requiring intramedullary fixation.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Smith & Nephew Richards’ Intramedullary Supracondylar Nail System

Submission Summary (Full Text)

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ACUMED™
K963077
OCT 1 1996
Quality Orthopaedic Instruments and Implants

# Enclosure D - 510(k) Summary

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.

The Acumed Supracondylar Nail is an intramedullary rod which addresses supracondylar fractures. The nail is available in six different sizes with diameters of 11 mm, 12 mm, and 13 mm and lengths of 150 mm and 220 mm. The nail is used in conjunction with 5 mm interlocking screws.

The Acumed Supracondylar Nail is manufactured from titanium per ASTM F 136. This device is provided pre-sterile. Sterility is achieved by gamma radiation. Validation of sterility is maintained on site. Sterility level is 10⁻⁶. Information regarding implantation, packaging, and labeling have been provided.

The Acumed Supracondylar Nail is similar to Smith & Nephew Richards’ Intramedullary Supracondylar Nail System in design, function, indications, and surgical technique and is expected to perform as well as similar devices.

10950 SW 5th St., Suite 170 Beaverton, OR 97005 [phone] Fax: [phone]
Form # FSUP-01 07/15/96 Page 8 of 10 © 1996, Acumed, Inc.