ACUMED CONGRUENT BONE PLATE SYSTEM

K063460 · Acumed, LLC · HRS · Dec 7, 2006 · Orthopedic

Device Facts

• Record ID: K063460
• Device Name: ACUMED CONGRUENT BONE PLATE SYSTEM
• Applicant: Acumed, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Dec 7, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia. and fibula.

Device Story

Acumed Congruent Bone Plate System consists of metallic bone plates and screws; used for internal fixation of fractures, fusions, and osteotomies in various long and small bones. Plates are pre-bent to minimize intraoperative contouring. Instruments provided to assist in plate and screw insertion. Used by surgeons in clinical/OR settings. Provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data provided; assessment of performance data and clinical/non-clinical tests deemed not applicable by the manufacturer.

Technological Characteristics

Materials: Titanium (ASTM F67, ASTM F136) and Stainless Steel (ASTM F138, ASTM F2229). Mechanical fixation system consisting of plates and screws. Provided non-sterile.

Indications for Use

Indicated for patients requiring bone fixation for fractures, fusions, or osteotomies of the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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)

Submission Summary (Full Text)

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## ACUMEDILLO

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 Compliance Officer

| Classification Name: | Single/multiple Component Metallic Bone Fixation Appliances and |
|----------------------------------------|-----------------------------------------------------------------|
| | Accessories |
| Common Name: | Plate, Fixation, Bone |
| Proprietary Name: | Acumed Congruent Bone 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 |

Device Description: The Acumed Scapula Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. 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 F67 and ASTM F136 and stainless steel in conformance with ASTM F138 and ASTM F2229. Plates and screws are provided non-sterile.

Intended Use: The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, 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 Scapula Congruent Bone Plate System is made out of Titanium as per ASTM F136 and Stainless Steel ASTM F138 and ASTM F2229. The predicates devices listed use similar materials

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 Congruent Bone Plate System and the predicate devices studied, the safety and effectiveness of the Acumed Congruent Bone Plate 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 stylized eagle with three curved lines representing its wings and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 7 2006

Acumed, LLC % Mr. Ed Boehmer Regulatory Compliance Officer 5885 NW Cornelius Pass Road Hillsboro, Oregon 97124

Re: K063460 Trade/Device Name: Acumed Congruent Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 10, 2006 Received: November 15, 2006

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, listing 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

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Page 2 - Mr. Ed Boehmer

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.

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/industry/support/index.html.

Sincerely yours,
Obalbag Buell

Mark N. Melkerson 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):

Acumed Congruent Bone Plate System Device Name:

Indications For Use:

The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, 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)

Barbara Brehind for mcm

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K063460

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