SYNTHES (USA) SPHERICAL WASHERS

K052483 · Synthes (Usa) · NDG · Nov 4, 2005 · Orthopedic

Device Facts

• Record ID: K052483
• Device Name: SYNTHES (USA) SPHERICAL WASHERS
• Applicant: Synthes (Usa)
• Product Code: NDG · Orthopedic
• Decision Date: Nov 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of large (long) bone and bone fragments. In addition, the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).

Device Story

Synthes Spherical Washers are orthopedic fixation accessories; round or oval design with slotted center hole; allows screw angulation up to 70 degrees. Used with 4.5 - 7.3 mm diameter screws; manufactured from stainless steel and titanium. Operated by surgeons in clinical/OR settings. Device functions by distributing mechanical load over a larger surface area of bone cortex; prevents screw head breakthrough; minimizes screw head projection during angled insertion. Benefits include improved fixation stability and reduced soft tissue irritation from prominent screw heads.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Stainless steel and titanium. Design: Round or oval washer with slotted center hole. Function: Accommodates screw angulation up to 70 degrees. Compatibility: 4.5 - 7.3 mm diameter screws. Mechanical fixation accessory.

Indications for Use

Indicated for patients requiring fracture fixation of large (long) bone and bone fragments where screw head projection must be minimized or cortical breakthrough prevented, particularly during procedures requiring acute screw angulation such as ankle arthrodesis.

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

• Synthes 13.0 mm Washer

Submission Summary (Full Text)

{0}------------------------------------------------

A SYNTHES.

:

'K052483p.4

| NOV | 4 2005 |
|-----|--------|
|-----|--------|

| 3.0 | 510(k) Summary | Page 1 of 1 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>[phone] | |
| Device Name: | Synthes Spherical Washers | |
| Classification: | 21 CFR 888.3030: Washer, bolt, nut, non-spinal, metallic (NDG)<br>21CFR 888.3040: Screw, Fixation, bone, non-spinal (HWC) | |
| Predicate Devices: | Synthes 13.0 mm Washer | |
| Device Description: | The Spherical Washers are round or oval in design with a slotted<br>center hole which allows for screw angulation up to 70 degrees.<br>They are used with 4.5 - 7.3 mm diameter screws and<br>manufactured from Stainless Steel and Titanium. | |
| Intended Use: | The Synthes Spherical Washers are intended to prevent a screw<br>head from breaking through the cortex of the bone by distributing<br>the forces/ load over a large area when used for fracture fixation of<br>large (long) bone and bone fragments.<br>In addition, the Spherical Washers are intended to prevent the<br>projection of the screw head, when the screw must be inserted at an<br>acute angle (e.g., in ankle arthrodesis). | |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. | |

{1}------------------------------------------------

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 with three lines representing its wings and a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the border of the circle.

NOV - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lisa M. Boyle Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K052483 Trade/Device Name: Synthes (USA) Spherical Washers Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: NDG, HWC Dated: October 19, 2005 Received: October 24, 2005

Dear Ms. Boyle:

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.

{2}------------------------------------------------

## Page 2 - Lisa M. Boyle

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,

C. M. Malik

Mark N. Metkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Page 1 of 1

2.0

Indications for Use

510(k) Number (if known):

KC52483

Device Name:

Synthes (USA) Spherical Washers

Indications for Use:

The Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of large (long) bone and bone fragments.

In addition, the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).

Prescription Use . . - X -(Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (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)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510/k) Number_KOS 2483