PROFYLE SYSTEM

K062498 · Howmedica Osteonics Corp. · HRS · Oct 25, 2006 · Orthopedic

Device Facts

• Record ID: K062498
• Device Name: PROFYLE SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Oct 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Profyle® System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

Device Story

Profyle® System is a line extension of bone fixation hardware; includes plates and screws, now featuring locking plate and locking screw options. Used by orthopedic surgeons for internal fixation of hand and wrist bones; procedures include replantation, lag screw techniques, joint fusions, corrective osteotomies, and fracture treatment. Device provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Metallic bone fixation system consisting of plates and screws. Includes locking and non-locking variants. Materials and design principles are consistent with previously cleared Profyle® systems.

Indications for Use

Indicated for internal fixation of hand and wrist bones, including replantation, lag screw techniques, joint fusions, corrective osteotomies, and fracture treatment.

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

• Profyle® Hand and Small Fragment System (K961497)
• Profyle® Hand and Small Fragment System (K980364)
• Stryker® Leibinger Universal Distal Radius System (K040022)
• Aptus® Titanium Osteosynthesis System, Medartis, Inc. (K051567)

Submission Summary (Full Text)

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K062498

OCT 25 2006

# 510(k) Summary of Safety and Effectiveness Profyle® System

| Proprietary Name: | Profyle® System |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone plates and screws |
| Classification Name/Reference: | Single/multiple component metallic bone fixation<br>appliances and accessories, 21 CFR §888.3030 |
| Device Product Code: | 87 HRS |
| Proposed Regulatory Class: | Class II |
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] Fax: [phone] |
| Date Summary Prepared: | August 24, 2006 |

## Description

This submission is a line extension to the Profyle® Hand and Small Fragment System to add alternate styles of plates and screws. Also, locking plates and locking screws are being added to the system.

### Indications:

The Profyle® System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

## Substantial Equivalence:

The subject Profyle® System is substantially equivalent to other plating systems in regards to intended use, design, materials, and operational principles as internal fixation components such as the Profyle® Hand and Small Fragment System (K961497 and K980364), Stryker® Leibinger Universal Distal Radius System (K040022), and Aptus® Titanium Osteosynthesis System, Medartis, Inc. (K051567.)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corporation % Vivian Kelly, RAC Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

OCT 2 5 2006

Re: K062498

Trade/Device Name: Profyle® 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: August 24, 2006 Received: August 25, 2006

Dear Ms. Kelly:

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 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 - Vivian Kelly, RAC

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 acidress http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Toubaya bichem

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Profyle® System

Indications for Use:

The Profyle® System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

Prescription Use Over-The-Counter Use >> AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Barbara Buckner

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

**510(k) Number** K062498

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