DEPUY ACE TIMAX PILON PLATE

K982347 · Depuy Ace Medical Co. · HRS · Aug 31, 1998 · Orthopedic

Device Facts

• Record ID: K982347
• Device Name: DEPUY ACE TIMAX PILON PLATE
• Applicant: Depuy Ace Medical Co.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pilon fractures - distal tibial intra-articular fractures · High medial malleolar fractures · Low Boot top type rotational distal extra-articular shaft fractures

Device Story

DePuy ACE TiMAX™ Pilon Plate is a metallic bone fixation plate for distal tibia fractures. Device features shaft with compression slots, distal metaphyseal diamond-shaped structure with screw/k-wire holes, and anterior-wrapping arm for articular surface reconstruction. Plate thickness varies (1.6mm shaft; 1.0mm distal) to balance strength with contouring flexibility. Supplied pre-formed to match distal tibia anatomy; surgeon performs final contouring to accommodate patient-specific topography. Used by orthopedic surgeons in clinical settings to stabilize fractures, facilitate anatomic reduction, and promote healing. Compatible with 3.5mm cortical, 4.0mm cancellous, and periarticular screws. Benefits include improved fracture stabilization and anatomic alignment.

Clinical Evidence

Bench testing only. Mechanical evaluation compared yield bending strength and bending stiffness against the predicate device.

Technological Characteristics

Material: Titanium 6Al-4V ELI (ASTM F136). Design: Pre-contoured plate with variable thickness (1.6mm shaft, 1.0mm distal). Features: Compression slots, k-wire guide holes, anterior arm for articular reconstruction. Compatible with 3.5mm cortical, 4.0mm cancellous, and periarticular screws. Non-powered, mechanical fixation device.

Indications for Use

Indicated for patients with pilon fractures (distal tibial intra-articular fractures), high medial malleolar fractures, and low boot top type rotational distal extra-articular tibial shaft fractures.

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 Cloverleaf Plate Stainless Steel (241.83) & Titanium (441.83)

Submission Summary (Full Text)

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AUG 3 1 1998

K982347

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## 510(k) SUMMARY

DePuy ACE Medical Company

El Segundo. CA 90245

Regulatory Affairs Specialist DePuy ACE Medical Company

DePuy ACE TiMAX™ Pilon Plate

fixation appliances and accessories.

Kathleen Dragovich

Bone Fixation Plate

2260 East El Segundo Boulevard

NAME OF FIRM:

510(k) CONTACT PERSON:

TRADE NAME:

COMMON NAME:

CLASSIFICATION:

DEVICE CODE:

SUBSTANTIALLY EQUIVALENT DEVICE: 87HRS

Synthes Cloverleaf Plate Stainless Steel (241.83) & Titanium (441.83)

888.3030 Single/multiple component metallic bone

## INTENDED USE:

- . Pilon fractures - distal tibial intra-articular fractures
- · High medial malleolar fractures

· Low Boot top type rotational distal extra-articular shaft fractures

## DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The DePuy ACE TiMAX™ Pilon Plate is a fracture fixation plate intended for use in pilon fractures (distal tibial intra-articular fractures), high medial malleolar fractures, and low boot type rotational distal extra-articular tibial shaft fractures. The plate profile consists of a shaft portion with compression slots, a diamond-shaped structure with four screw holes and two k-wire guide holes for the distal metaphyseal region, and finally, an arm which wraps anteriorly to address the anterior crush fracture and facilitate articular surface reconstruction. The plate thickness is 1.6 mm in the shaft region and is decreased to 1 mm in the distal region to facilitate contouring and maintaining anatomic reduction of the fracture. The shaft portion is thicker for strength

The plate is supplied pre-formed to a contour, which closely matches the distal tibia anatomy. The general contour includes a medial bend from the distal metaphyseal region combined with an internal rotation. The most distal profile includes the anterior arm with a large bend from the medial to the anterior surface with the bend apex located adjacent to the anterior strut.

The open architecture of the distal region allows easy contouring by the surgeon to accommodate the anatomical topography of the distal tibia and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw, 4.0mm cancellous screw, and the periarticular screw. The plate will be offered in a right and left model with various lengths of the shaft region.

The DePuy ACE TiMAX™ Pilon Plate is manufactured from Titanium 6A1-4V ELI (per ASTM standard F136).

DePuy ACE TiMAX™ Pilon Plate was compared to the Synthes steel cloverleaf plate and was found to have a higher yield bending strength and was lower bending stiffness.

Based on the above information, DePuy ACE Medical Company firmly believes that the new DePuy ACE TiMAX™ Pilon Plate is substantially equivalent to the Synthes Steel Cloverleaf Plate (pre-amendment device).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a person embracing another person.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 1998

Mr. Paul Doner Director, Regulatory and Clinical Affairs DePuy ACE Medical Company 2260 East El Segundo Boulevard El Segundo, California 90245-4694

K982347 Re: DePuy ACE TiMAX™ Pilon Plate Trade Name: Regulatory Class: II Product Code: HRS Dated: July 2, 1998 Received: July 6, 1998

Dear Mr. Doner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Paul Doner

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colin M. Witton, Ph.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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●DePuyACE

510(k) Number (if known)

Device Name: DePuy ACE TiMAX™ Pilon Plate

K982347

Indications for Use:

ﻛﺴﺴﺴ

- · Pilon fractures distal tibial intra-articular fractures
- High medial malleolar fractures
- Low Boot top type rotational distal extra-articular shaft fractures

Concurrence of CDRH, Office of Device Evaluation

X Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter

Ascoella

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K982347