STRYKER PLATING SYSTEM

K060798 · Howmedica Osteonics Corp. · HRS · Apr 12, 2006 · Orthopedic

Device Facts

• Record ID: K060798
• Device Name: STRYKER PLATING SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Apr 12, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following: One third tubular plate: fibula, metatarsals, metacarpals Fibular plate: fibula Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.

Device Story

Stryker® Plating System is a line extension of existing bone fixation hardware; includes metallic plates and screws for internal fracture fixation. Device provides mechanical stabilization of bone fragments in long bones, metaphysis, and diaphysis. Used by orthopedic surgeons in clinical/surgical settings. Plates and screws are implanted to hold bone fragments in alignment during healing process; provides structural support to facilitate osteosynthesis. No electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Metallic bone fixation plates and screws. System includes various plate styles (tubular, compression, T-plate, L-buttress, reconstruction, etc.) for specific anatomical sites. Mechanical fixation device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients with fractures of the metaphysis, diaphysis, or long bones, including femur, tibia, humerus, pelvis, radius, ulna, fibula, clavicle, calcaneus, and metatarsals/metacarpals. Used for fracture fixation and bone fragment stabilization via plates and screws.

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.

Submission Summary (Full Text)

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Kolo798

# Summary of Safety and Effectiveness Stryker® Plating System Line Extension

| Proprietary Name: | Stryker® Plating System |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone Plate System |
| Classification Name and Reference: | Single/Multiple Component Metallic Bone<br>Fixation Appliances and Accessories, 21 CFR<br>§888.3030 |
| Proposed Regulatory Class: | Smooth or Threaded Metallic Bone Fixation<br>Fastener, 21 CFR §888.3040<br>Class II |
| Device Product Code: | 87 HRS: Plate, Fixation, Bone<br>87 HWC: Screw, Fixation, Bone |
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |

Date Summary Prepared:

March 23, 2006

#### Description:

This Special 510(k) submission is a line extension to address modifications to the Stryker® Plating System (SPS), which includes the SPS Small Fragment Set, the SPS Basic Fragment Set, the SPS Pelvic Set and the Stryker Locked Plating Set. This line extension is to add additional styles of plates based on the plates in the SPS Small Fragment Set and the SPS Basic Fragment Set.

#### Intended Use

The modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for the subject plates are provided below.

#### Indications

The indications for use for the predicate plates are provided below. The subject plates and subject accessories have the same indications as cleared their predicates.

SPS Small Fragment Set The Stryker Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following:

One third tubular plate: fibula, metatarsals, metacarpals Fibular plate: fibula Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle

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Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis

Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.

SPS Basic Fragment Set The Basic Fragment Set is intended for use in long bone fracture fixation.

Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis.

T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.

#### Substantial Equivalence:

These additional components are substantially equivalent to their predicate systems from the Stryker® Plating System in respect to design, intended use, performance and operational principle as internal fixation components.

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Image /page/2/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 with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and is in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2006

Howmedica Osteonics Corporation c/o Ms. Vivian Kelly Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K060798

Trade/Device Name: Stryker® Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: March 23, 2006 Received: March 24, 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

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# Page 2 - Ms. Vivian Kelly

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/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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K 060798

# Indications for Use

510(k) Number (if known):

Device Name: Stryker® Plating System

Indications for Use:

# SPS Small Fragment Set

The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following:

One third tubular plate: fibula, metatarsals, metacarpals Fibular plate: fibula Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis

Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.

### SPS Basic Fragment Set

The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.

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

> e of Device Evaluation (ODE) Concurrence of CI

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(Division Sign-Division of General, Restorative. and Neurological Devices

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510(k) Number_ Ko60798