← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K962091

# POLARUS AF ROD (K962091)

_Acu Med, Inc. · HSB · Jul 24, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K962091

## Device Facts

- **Applicant:** Acu Med, Inc.
- **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md)
- **Decision Date:** Jul 24, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3020
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The Polarus AF Rod is an intramedullary rod which addresses tibiocalcaneal arthrodesis procedures (ankle fusions).

## Device Story

Intramedullary rod for tibiocalcaneal arthrodesis; 11 mm x 150 mm dimensions; interlocked via 4.5 mm cortical screws; implanted by orthopedic surgeons in clinical/OR setting; provides structural stabilization for ankle fusion; benefits patient through rigid fixation during bone healing.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Material: 6AL/4V ELI titanium alloy per ASTM F 136; dimensions: 11 mm x 150 mm; fixation: 4.5 mm cortical screws; sterilization: gamma radiation (SAL 10⁻⁶).

## Regulatory 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, Inc.’s Intramedullary Rod

## Submission Summary (Full Text)

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{0}

ACUMED™

K 962 091

JUL 24 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 Polarus AF Rod is an intramedullary rod which addresses tibiocalcaneal arthrodesis procedures (ankle fusions). The rod’s dimensions are 11 mm x 150 mm and it is interlocked in place by 4.5 mm cortical screws.

The Polarus AF Rod is manufactured from 6AL/4V ELI 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 Polarus AF Rod is similar to Smith & Nephew Richards, Inc.’s Intramedullary Rod 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 ♦ (503) 627-9957 ♦ Fax: (503) 643-1909 ♦

Form # FPAF-01 05/24/96 Page 8 of 10 © 1995, Acumed, Inc.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K962091](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K962091)

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