ACUMED SMALL BONE LOCKING ROD SYSTEM II

K031438 · Acumed, LLC · HSB · Jul 17, 2003 · Orthopedic

Device Facts

• Record ID: K031438
• Device Name: ACUMED SMALL BONE LOCKING ROD SYSTEM II
• Applicant: Acumed, LLC
• Product Code: HSB · Orthopedic
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acumed Small Bone Locking Rod II System is indicated for use in fractures and osteotomies of the fibula, radius, and ulna.

Device Story

Intramedullary rod system for fixation of fibula, radius, and ulna fractures and osteotomies. Device consists of solid or cannulated rods (110-270mm length; 3.0-4.5mm diameter) used with titanium alloy cortical screws for locking. Implanted by surgeons in clinical settings to stabilize bone segments. Provides mechanical support for bone healing.

Clinical Evidence

No clinical data provided. Bench testing not applicable per manufacturer statement.

Technological Characteristics

Intramedullary fixation rod; titanium 6AL EVI alloy (ASTM F136); solid and cannulated configurations; lengths 110-270mm; diameters 3.0-4.5mm; locking mechanism via cortical screws.

Indications for Use

Indicated for patients requiring fixation for fractures and osteotomies of the fibula, radius, and ulna.

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

• Acumed Small Bone Locking Rod System (K951673)
• Biomet Inc. Titanium Intramedullary Rods (K982953)
• Biomet Inc. S.S.T. Small Bone Locking Nail (K# unknown)
• Encore Orthopedics Inc. True/Flex Intramedullary Rod (K913949)

Submission Summary (Full Text)

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## JUL 17 2003

# AGUMEDILLC

5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432

Tel [phone]

#### 510(k) Summary

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Submitter Information: | Acumed LLC |
|------------------------|-----------------------------------|
| | 5885 N.W. Cornelius Pass Road |
| | Hillsboro, OR 97124-9432 |
| | USA |
| Phone: | [phone] |
| FAX: | [phone] |
| Contact: | Ed Boehmer, Regulatory Specialist |

| Classification Name: | Rod, Fixation, Intramedullary and Accessories |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Radius, Ulna, and Fibula Rods |
| Proprietary Name: | Acumed Small Bone Locking Rod System II |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3020 |
| Device Product Code: | HSB |
| Legally Marketed Equivalent Device(s): | Acumed Small Bone Locking Rod System K951673<br>Biomet Inc. Titanium Intramedullary Rods Various Sizes K982953<br>Biomet Inc. S.S.T. Small Bone Locking Nail K# unknown<br>Encore Orthopedics Inc. True/Flex Intramedullary Rod K913949 |

Device Description: The Acumed Small Bone Locking Rod II is an intramedullary rod with solid and cannulated versions. Rods are manufactured in multiple lengths (110 mm to 270mm) and diameters (3.0 to 4.5 mm). The rod has openings used in conjunction with titanium alloy cortical screws, which lock it in place.

Intended Use: The Acumed Small Bone Locking Rod II System is indicated for use in fractures and osteotomies of the fibula, radius, and ulna. These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.

Technological Characteristics: The Acumed Small Bone Locking Rods II are slightly bowed rods made from titanium 6AL EVI alloy in conformance with ASTM F136. The predicate devices are made of identical titanium alloy or stainless steel. Both titanium alloy and stainless steel have been successfully used in numerous intramedullary rods. There are no technological characteristics that raise new issues of safety or effectiveness.

An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.

Based upon the similarities of the Acumed Small Bone Rod II System and the predicate devices studied, the safety and effectiveness of the Acumed Small Bone Rod II System is substantially equivalent to the predicate devices referenced.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles connected to three wave-like shapes, which is a common symbol associated with the department.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2003

Mr. Ed Boehmer Regulatory Specialist Acumed LLC 5885 N.W. Cornelius Pass Road Hillsboro, Oregon 97124

Re: K031438

> Trade Name: Small Bone Locking Rod System II Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: May 1, 2003 Received: May 6, 2003

Dear Mr. Boehmer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. '

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Ed Boehmer

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark N Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1 Page

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Small Bone Locking Rod System II Device Name:

Indications For Use:

The Acumed Small Bone Locking System II and accessories are designed specifically for fractures and osteotomies of the fibula, radius, and ulna.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milliken

storative

510(k) Noran

(Optional Format 3-10-98)

Page 74 Acumed LLC