DEPUY AE TK2 HIP SCREW SYSTEM

K972629 · Depuy, Inc. · KTT · Oct 9, 1997 · Orthopedic

Device Facts

• Record ID: K972629
• Device Name: DEPUY AE TK2 HIP SCREW SYSTEM
• Applicant: Depuy, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Oct 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy ACE TK2 Hip Screw System is indicated for fractures of the proximal femur extending from the subcapital area to the level of the lesser trochanter, as well as proximal femoral osteotomies. Appropriate utilization of this device ultimately depends on the surgical judgement surrounding each patient's particular situation.

Device Story

Fixed-angle orthopedic bone fixation system; consists of lag screws and plates. Lag screws available in keyed (rotationally locked) and keyless versions; plates offered in 2-14 hole lengths with 130°-150° angles. Designed for surgical implantation in proximal femur; lag screw assembly slides within barrel to facilitate fracture site compaction, transfer bone load, and prevent acetabular penetration. Used by orthopedic surgeons in clinical/OR settings to stabilize fractures and osteotomies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation appliance; fixed-angle plate system with sliding lag screw assembly. Materials: metallic (implants). Connectivity: none. Software: none. Sterilization: not specified.

Indications for Use

Indicated for patients with proximal femur fractures (subcapital area to lesser trochanter) and those requiring proximal femoral osteotomies.

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 Dynamic Hip Screw (DHS) System (K791619)
• DePuy ACE Select Lock Hip Screw System (K861178)

Submission Summary (Full Text)

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K972639
510(k) SUMMARY

Image /page/0/Picture/1 description: The image shows the logo for DePuy ACE. The logo consists of a black circle followed by the text "DePuyACE" in a bold, sans-serif font. The letters are all capitalized, and the word "ACE" is slightly larger than "DePuy". There is a small TM symbol in the bottom right corner of the logo.

**510(k) SUMMARY**

| NAME OF FIRM: | OCT<br>- 9 1997<br>DePuy ACE Medical Company<br>2260 East El Segundo Boulevard<br>El Segundo, CA 90245 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT PERSON: | Kathleen Dragovich<br>Regulatory Affairs Specialist<br>DePuy ACE Medical Company |
| TRADE NAME: | DePuy ACE TK2 Hip Screw System |
| COMMON NAME: | Compression Hip Screw |
| CLASSIFICATION: | 888.3030 Single/multiple component metallic bone<br>fixation appliances and accessories |
| DEVICE CODE: | 87LXT |
| SUBSTANTIALLY<br>EQUIVALENT DEVICE: | Synthes Dynamic Hip Screw (DHS) System and<br>DePuy ACE Select Lock Hip Screw System |

## INTENDED USE:

The DePuy ACE TK2 Hip Screw System is indicated for fractures of the proximal femur extending from the subcapital area to the lesser trochanter, as well as proximal femoral osteotomies. Appropriate utilization of this device ultimately depends on the surgical judgement surrounding each paticular situation.

## DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The TK2 Hip Screw System will be a fixed-angle plate with the option to be rotationally locked. The system will offer two lag screws: one with external keys to rotationally "lock," and the other without keys. The design will allow the lag screw assembly to slide within the barrel to ensure continuous compaction of the fracture sight, transfer of the bone instead of the implant, and reduce the risk of acetabular penetration.

The plates will initially be offered in 2 through 14 hole lengths. The plate will be offered in all lengths in 130°, 135°, 140°, 145°, and 150°; and in a short barrel and standard barrel lengths. The lag screws will initially be offered in a keyed and keyless version in lengths from 50mm through 140mm. The lag screws will be offered in a super and standard thread form.

The DePuy ACE TK2 Hip Screw System is similar in design to the Synthes Dynamic Hip System (510k approval K791619) and the DePuy ACE Select Lock Hip Screw System (regulatory assessment approval based on K861178 released 4/15/86), which are indicated for fractures of the proximal femur extending from the subcapital area to the level of the lesser trochanter, as well as proximal femoral osteotomies

Based on the above information, DePuy ACE Medical Company firmly believes that the new DePuy ACE TK2 Hip Screw System is substantially equivalent to the Synthes Dynamic Hip Screw System and the DePuy ACE Select Lock Hip Screw System.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathleen A. Draqovich Requlatory Affairs Specialist DePuy, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

OCT - 9 1997

Re: K972629 Trade Name: DePuy Ace TK2 Hip Screw System Requlatory Class: II Product Code: KTT Dated: July 11, 1997 Received: July 14, 1997

Dear Ms. Dragovich:

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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಕ 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 requlation may result in requlatory action. In addition, FDA may publish further announcements 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 - Ms. Kathleen A. Dragovich

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 regulation (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,

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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510(k) Number (if known)

K972629

DePuy ACE TK2 Hip Screw System Device Name:

Indications For Use:

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The DePuy ACE TK2 Hip Screw System is indicated for fractures of the proximal femur extending from the subcapital area to the level of the lesser trochanter, as well as proximal femoral osteotomies. Appropriate utilization of this device ultimately depends on the surgical judgement surrounding each patient's particular situation.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter

tacoello

(Division Sign-Off) (Division of General Restorative Device 510(k) Number