ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM

K051083 · Acumed, LLC · HRS · May 12, 2005 · Orthopedic

Device Facts

• Record ID: K051083
• Device Name: ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
• Applicant: Acumed, LLC
• Product Code: HRS · Orthopedic
• Decision Date: May 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acumed Scapula Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies. The Acumed Scapula Congruent Bone Plates plates and screws designed specifically for the scapula.

Device Story

System consists of titanium bone plates and screws designed for scapular fixation. Plates are pre-bent to minimize intraoperative contouring. Instruments are provided to assist in plate and screw insertion. Used by surgeons in clinical settings for orthopedic procedures involving fractures, fusions, or osteotomies. Provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium per ASTM F136. Form factor: Pre-bent bone plates and screws. Energy source: None (mechanical). Sterilization: Provided non-sterile.

Indications for Use

Indicated for fixation of scapular fractures, fusions, and osteotomies.

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)
• Synthes (USA) One-Third Tubular DCL Plate (K011335)

Submission Summary (Full Text)

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KOS1083

MAY 1 2 2005

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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 & Documentation Supervisor |

| Classification Name: | Single/multiple Component Metallic Bone Fixation Appliances and<br>Accessories |
|----------------------------------------|-----------------------------------------------------------------------------------------------------|
| Common Name: | Plate, Fixation, Bone |
| Proprietary Name: | Acumed Scapula 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<br>Synthes (USA) One-Third Tubular DCL Plate K011335 |

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. Plates and screws are provided non-sterile.

Intended Use: The Acumed Scapula Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies. The Acumed Scapula Congruent Bone Plates plates and screws designed specifically for the scapula.

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 are made out of Titanium as per ASTM F136. The predicates devices listed use Titanium as per ASTM F67 and 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 Scapula Congruent Bone Plate System and the predicate devices studied, the safety and effectiveness of the Acumed Scapula 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 and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2005

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

Re: K051083

Trade/Device Name: Acumed Scapula Congruent Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 26, 2005 Received: April 27, 2005

Dear Mr. Boehmer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocater on (a) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreate) to tegrees and the Medical Device Amendments, or 10 conninered pror to may 2003 received in accordance with the provisions of the Federal Food, Drug, de nees may nave been room do require approval of a premarket approval application (PMA). alla Cosmetic 71ct (71ct) that ad nevice, subject to the general controls provisions of the Act. The r out may, mercere, market are a Act include requirements for annual registration, listing of general controlo proficious proctice, labeling, and prohibitions against misbranding and adulteration.

ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is elaboritia dditional controls. Existing major regulations affecting your device it may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Could of I seems concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Dr b ibeau.that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I cacial stututed and registerients, including, but not limited to: registration and listing (21 Comply with an the Act 31equirements)01); good manufacturing practice requirements as set CFN in the quality systems (21 CFR Part 820); and 1f applicable, the electronic forul in the quality bybiolis (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) This letter will anow you to ough manies.ing of substantial equivalence of your device to a legally prematics notification. "The PDT Interlig cification 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 advice for your act 100 % or an other more the regulation entitled, Colliact the Office of Comphalled as (= + notification" (21CFR Part 807.97). You may obtain Misolanding by relevelee to promansonsibilities under the Act from the Division of Small other general informational 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,

Miriam C. Provost, Ph.D.

Acting 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): K051083

Device Name: Acumed Scapula Congruent Bone Plate System

Indications For Use:

The Acumed Scapula Congruent Bone Plate System provides fixation during fractures, fusions, and osteotomies for the scapula.

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)

Hypt. Edwards

(Divisi Division of General, Restorative, and Neurological Devices

510(k) Number K051083

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