STRYKER PLATING SYSTEM PERIARTICULAR PLATES

K031959 · Howmedica Osteonics Corp. · LXT · Jul 25, 2003 · Orthopedic

Device Facts

• Record ID: K031959
• Device Name: STRYKER PLATING SYSTEM PERIARTICULAR PLATES
• Applicant: Howmedica Osteonics Corp.
• Product Code: LXT · Orthopedic
• Decision Date: Jul 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 3.5mm and 4.5mm Periarticular Plate components are intended for use in long bone fracture fixation. The 3.5mm and 4.5mm proximal tibial Periarticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the tibia. The 4.5mm distal femur Periaticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the femur.

Device Story

Stryker Plating System Periarticular Plates are metallic bone fixation implants; designed for surgical stabilization of long bone fractures in cortical and metaphyseal regions. Plates are manufactured from 316L stainless steel. Device is used by orthopedic surgeons in clinical/OR settings to provide structural support to fractured bone segments. Surgeon selects appropriate plate size (3.5mm or 4.5mm) based on fracture location (e.g., proximal tibia, distal femur) and patient anatomy. Plates are secured to bone using compatible screws. Output is mechanical stabilization of the fracture site, facilitating bone healing and patient recovery. Device serves as a line extension to existing Stryker Plating System sets.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by Finite Element Analysis (FEA) comparing mechanical properties of subject plates to predicate devices.

Technological Characteristics

Metallic bone fixation plates; material: 316L stainless steel; dimensions: 3.5mm and 4.5mm variants; intended for cortical and metaphyseal long bone fracture fixation; mechanical properties validated via FEA.

Indications for Use

Indicated for fixation of long bone fractures, including fractures of the tibia and femur, in patients requiring surgical stabilization of cortical and metaphyseal bone regions.

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

• SPS Small Fragment Set (K031959)
• SPS Basic Fragment Set (K031959)

Submission Summary (Full Text)

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Line Extension to the SPS Small Fragment Set and SPS Basic Fragment Set - 3.5mm and 4.5mm Periarticular Plates

Special 510(k) Premarket Notification

JUL 2 5 2003

# Special 510(k) Summary of Safety and Effectiveness: Line Extension t Fragment Set and SPS Basic Fragment Set - 3.5mm and 4.5mm Periarticular Plates

#### Submission Information

| | Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp.<br>59 Route 17 South<br>Allendale, NJ 07401-1677 |
|--|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Vivian Kelly<br>Regulatory Affairs Consultant<br>Phone: [phone]<br>Fax: [phone] |
| | Date of Summary Preparation: | June 18, 2003 |
| | Device Identification | |
| | Proprietary Name: | Stryker Plating System Periarticular Plates |
| | Common Name: | Bone Plate System |
| | Classification Name and Reference: | Single/Multiple Component Metallic Bone Fixation<br>Appliances and Accessories, 21 CFR §888.3030<br>Smooth or Threaded Metallic Bone Fixation<br>Fastener, 21 CFR §888.3040 |

Regulatory Class:

#### Description

This Special 510(k) submission is intended to address a line extension to the predicate SPS Small Fragment Set and SPS Basic Fragment Set which are both part of the Stryker Plating System. Both the SPS Small Fragment Set and SPS Basic Fragment Set consist of plates and screws for the fixation of fractures of the cortical and metaphyseal areas of long bones as well as fractures of the pelvis. There is no change in intended use for the modified device when compared to the previously cleared devices. The line extension involves offering a new Periarticular Plate version for the fixation of fractures of the cortical and metaphyseal regions of long bones. Howmedica Osteonics intends to add the new components to the current product line, thereby offering additional design options for the surgeon. The Periarticular Plates will be available in stainless steel (316L).

Class II

## Intended Use

The Periarticular Plates are intended for use in long bone fracture fixation.

## Substantial Equivalence

Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed plating systems. Analysis has been conducted demonstrating substantial equivalence to a currently marketed device.

## Statement of Technological Comparison

FEA analysis demonstrates the comparable mechanical properties of the subject Periarticular Plates and predicate SPS Basic Fragment Set.

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Line Extension to the SPS Small Fragment Set and SPS Basic Fragment Set - 3.5mm and 4.5mm Periarticular Plates

Special 510(k) Premarket Notification

**Device Identification**

KO31959
page 2 of 2

Proprietary Name:

Stryker Plating System Periarticular Plates

Common Name:

Bone Plate System

Class II

Classification Name and Reference:

Single/Multiple Component Metallic Bone Fixation Appliances and Accessories, 21 CFR §888.3030

Smooth or Threaded Metallic Bone Fixation Fastener, 21 CFR §888.3040

Proposed Regulatory Class:

Device Panel/Product Code:

87 HRS: Plate, Fixation, Bone 87 HWC: Screw, Fixation, Bone

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Image /page/2/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 an eagle or bird with three curved lines representing its wings or feathers.

JUL 25 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Vivian Kelly Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Re: K031959

Trade/Device Name: Stryker Plating System Periarticular Plates Regulation Number: 21 CFR 3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: June 18, 2003 Received: June 25, 2003

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

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#### Page 2 - Ms. Vivian Kelly

forth in the quality systems (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.

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.

to Mark A. Milkerson

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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Page 1 of 1

#### 510(k) Number (if known): K031959

Device Name: 3.5mm and 4.5mm Periarticular Plates

Indications For Use:

The 3.5mm and 4.5mm Periarticular Plate components are intended for use in long bone fracture fixation.

The 3.5mm and 4.5mm proximal tibial Periarticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the tibia. The 4.5mm distal femur Periaticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the femur.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Per 21 CFR 801.109)

Ad. Mem.

vision of General. Restorative and Neurological Devices

510(k) Number _