ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM

K033639 · Acumed, LLC · HWC · Jan 15, 2004 · Orthopedic

Device Facts

• Record ID: K033639
• Device Name: ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
• Applicant: Acumed, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Jan 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acumed Lower Extremity Congruent Plate System is indicated for use in providing fixation during fractures, fusions, and osteolomies. The Acumed Lower Extremity Congruent Plate System includes plates and screws designed specifically for the phalanges, metatarsals, tarsals, tibia and fibula.

Device Story

System consists of titanium bone plates and screws used for orthopedic fixation of fractures, fusions, and osteotomies in lower extremities (phalanges, metatarsals, tarsals, tibia, fibula). Plates are pre-bent to minimize intraoperative contouring. Instruments are provided to assist in plate and screw insertion. Device is used by surgeons in clinical settings. Output is mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium per ASTM F136. Components: Bone plates and screws. Form factor: Pre-bent plates for lower extremity anatomy. Sterilization: Provided non-sterile.

Indications for Use

Indicated for fixation during fractures, fusions, and osteotomies of the phalanges, metatarsals, tarsals, tibia, and fibula.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Acumed LLC Congruent Bone Plate System (K012655)
• Synthes USA Modular Foot System (K001941)
• Synthes USA Cannulated Angle Blade Plate System (K974537)
• Depuy Ace Medical Co. Timax Pilon System (K982347)
• Synthes USA Calcaneal Plate (K020401)
• Depuy Ace Medical Co. Timax Calcaneal Peri-Articular Plate (K981775)

Submission Summary (Full Text)

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acum

K033439

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

Tel [phone]

510(k) Summary

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

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

| Classification Name: | Single/multiple Component Metallic Bone Fixation Appliances and<br>Accessories |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Plate, Fixation, Bone |
| Proprietary Name: | Acumed Lower Extremity Congruent Plate System |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3030 |
| Device Product Code: | HRS |
| Legally Marketed Equivalent Device(s): | Acumed LLC Congruent Bone Plate System K012655<br>Synthes USA Modular Foot System K001941<br>Synthes USA Cannulated Angle Blade Plate System K974537<br>Depuy Ace Medical Co. Timax Pilon System K982347<br>Synthes USA Calcaneal Plate K020401<br>Depuy Ace Medical Co. Timax Calcaneal Peri-Articular Plate<br>K981775 |

Device Description: The Acumed Lower Extremity Congruent Plate System consists of bone plates and screws for fractures, fusions, and osteotomes: The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium in conformance with ASTM F136. Plates and screws are provided non-sterile.

Intended Use: The Acumed Lower Extremity Congruent Plate System is indicated for use in providing fixation during fractures, fusions, and osteolomies. The Acumed Lower Extremity Congruent Plate System includes plates and screws designed specifically for the phalanges, metatarsals, tarsals, tibia and fibula.

These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.

Technological Characteristics: The Acumed Lower Extremity Congruent Plate System are made out of Titanium as per ASTM F136. The predicates devices listed use cither 316L stainless steel or Titanium as per ASTM F136.

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 Lower Extremity Congruent Plate System and the predicate devices studied, the safety and effectiveness of the Acumed Lower Extremity Congruent Plate System is substantially equivalent to the predicate devices referenced.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2004

Mr. Ed Boehmer Regulatory and Documentation Supervisor Acumed LLC 5885 N.W. Cornelius Pass Road Hillsboro, Oregon 97124-9432

Re: K033639

K035057
Trade/Device Name: Acumed Lower Extremity Congruent Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC Dated: November 14, 2003 Received: November 24, 2003

Dear Mr. Boehmer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Tor use stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or 10 commerce print to they 20, 1978, are eccordance with the provisions of the Federal Food. Drug. de necs that have boon reciasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, morelore, market and act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

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

Please be advised that I'DA's issuance of a substantial equivalence determination docs not mean I Toase be advised that I DPT of issuation its your device complies with other requirements of the Act that 1171 has made a sond regulations administered by other Federal agencies. You must or any I outhal bithe Act's requirements, including, but not limited to: registration and listing (21 ClFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 8077, adomig (21 OS) 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 Scction 510(k) rms letter with anow your to organization 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 If you desire specific arries 101 ) 594-4659. Also, please note the regulation entitled. Connior the Ories of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micrination of your Copymer 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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## Indications For Use

510(k) Number (if known): K033639

Device Name: Acumed Lower Extremity Congruent Plate System

Indications For Use:

The Acumed Lower Extremity Congruent Plate System provides fixation during fractures, fusions, and osteotomies for the phalanges, metatarsals, tibia and fibula.

Prescription Use X_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

f Mark N. Milken

Division of O
Neurological L