TBD

K963026 · Acu Med, Inc. · HSB · Oct 28, 1996 · Orthopedic

Device Facts

• Record ID: K963026
• Device Name: TBD
• Applicant: Acu Med, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Oct 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acumed Retrograde Humeral Nail is an intramedullary rod which addresses humeral fractures. The nail is 8 mm in diameter and is available in a lengths of 200 mm, 220 mm, 240 mm, 260 mm, 280 mm, and 300 mm. It is used in conjunction with 3.5 mm interlocking screws.

Device Story

Intramedullary rod for humeral fracture fixation; 8 mm diameter; lengths 200-300 mm; used with 3.5 mm interlocking screws. Surgical implant; used by orthopedic surgeons in clinical/OR settings. Provides mechanical stabilization of humeral fractures to facilitate healing.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Titanium per ASTM F 136; intramedullary rod form factor; gamma radiation sterilization (10⁻⁶ SAL).

Indications for Use

Indicated for patients with humeral 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' Russell-Taylor Humeral Interlocking Nail

Submission Summary (Full Text)

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OCT-24-1996 12:13 FROM -GUTS 10
13615942000
ACUMED™ K963026
Quality Orthopaedic Instruments and Implants
Enclosure D - 510(k) Summary OCT 28 1996

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 Retrograde Humeral Nail is an intramedullary rod which addresses humeral fractures. The nail is 8 mm in diameter and is available in a lengths of 200 mm, 220 mm, 240 mm, 260 mm, 280 mm, and 300 mm. It is used in conjunction with 3.5 mm interlocking screws.

The Acumed Retrograde Humeral 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 Retrograde Humeral Nail is similar to Smith & Nephew Richards' Russell-Taylor Humeral Interlocking Nail in design, function, indications, and surgical techniques and is expected to perform as well as similar devices.

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