SYNTHES PILON PLATE

K020602 · Synthes · HRS · May 20, 2002 · Orthopedic

Device Facts

• Record ID: K020602
• Device Name: SYNTHES PILON PLATE
• Applicant: Synthes
• Product Code: HRS · Orthopedic
• Decision Date: May 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Pilon Plate is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia.

Device Story

Synthes Pilon Plate; metal bone fixation plate; designed for distal tibia fractures; features screw-to-plate locking mechanism; used by orthopedic surgeons in clinical/surgical settings; provides mechanical stabilization of bone fragments during healing; facilitates fracture fixation and osteotomy management.

Clinical Evidence

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

Technological Characteristics

Metallic bone fixation plate; materials: stainless steel or titanium; features screw-to-plate locking mechanism; intended for distal tibia; class II device (21 CFR 888.3030).

Indications for Use

Indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia in patients requiring surgical stabilization.

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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#### 3. Summary of Safety and Effectiveness Information

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| Sponsor | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Matthew M. Hull<br>[phone] ext. 7191 |
| Name of the Device | Synthes Pilon Plate |
| Device Classification(s) | Class II, §888.3030 - Plate, Fixation, Bone |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes Pilon<br>Plate to be substantially equivalent to other legally marketed devices. |
| Device Description | The Synthes Pilon Plate is a metal plate that offers screw to plate<br>locking designed for various fracture modes of the distal end of the<br>tibia. |
| Indications | The Synthes Pilon Plate is intended for fixation of complex intra- and<br>extra-articular fractures and osteotomies of the distal tibia. |
| Materials | Stainless Steel or Titanium |

Synthes (USA) Synthes Pilon Plate 510(k) CONFIDENTIAL

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 0 2002

Mr. Matthew M. Hull Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road PO Box 1766 Paoli, PA 19301

Re: K020602

Trade/Device Name: Synthes Pilon Plate Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: February 19, 2002 Received: February 22, 2002

Dear Mr. Hull:

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 - Mr. Matthew M. Hull

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter will and h your e FDA finding of substantial equivalence of your device to a legally premated predicated on "ceresults 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 A. Milhenser

Celia 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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#### Indications for Use Statement

2.

510(k) Number (if known):

Device Name:

Indications for Use:

C20602

Synthes Pilon Plate

The Synthes Pilon Plate is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

109)
la Mark N. Milkinson

(Division Sign-Off) Division of General, Restoreralve and Neurological Device

510(k) Number K020607

Synthes (USA) Synthes Pilon Plate 510(k) CONFIDENTIAL