Who is the manufacturer of POLARUS AF ROD?

Acu Med, Inc. filed the 510(k) submission for POLARUS AF ROD (K962091).

What is the FDA product code for POLARUS AF ROD?

HSB. It is classified under 21 CFR 888.3020 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for POLARUS AF ROD?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like POLARUS AF ROD?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

POLARUS AF ROD

Q: What are the predicate devices for POLARUS AF ROD?

Smith & Nephew Richards, Inc.’s Intramedullary Rod.

K962091 · Acu Med, Inc. · HSB · Jul 24, 1996 · Orthopedic

Device Facts

Record ID	K962091
Device Name	POLARUS AF ROD
Applicant	Acu Med, Inc.
Product Code	HSB · Orthopedic
Decision Date	Jul 24, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3020
Device Class	Class 2
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).

Indications for Use

Indicated for patients requiring tibiocalcaneal arthrodesis (ankle fusion).

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, Inc.’s Intramedullary Rod

Related Devices

K043052 — TRIGEN HINDFOOT FUSION NAIL · Smith & Nephew, Inc. · Nov 24, 2004
K021786 — TITANIUM ANKLE ARTHRODESIS NAIL · Biomet, Inc. · Aug 26, 2002
K091976 — BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL · Biomet Trauma · Aug 17, 2009
K113828 — DYNANAIL ANKLE ARTHRODESIS NAIL · MedShape, Inc. · Feb 29, 2012
K201227 — Phantom® Hindfoot TTC/TC Nail System · Paragon 28, Inc. · Jul 17, 2020

Submission Summary (Full Text)

{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.