DEPUY ACE COMPOSITE LOCKING NUT

K983265 · Depuy Ace Medical Co. · HTN · Oct 26, 1998 · Orthopedic

Device Facts

• Record ID: K983265
• Device Name: DEPUY ACE COMPOSITE LOCKING NUT
• Applicant: Depuy Ace Medical Co.
• Product Code: HTN · Orthopedic
• Decision Date: Oct 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy ACE Composite Locking Nut is used as follows: Cortical bone screws (alone) Intramedullary nails as locking bolts Screws with plates Where extra purchase in far cortex is required

Device Story

DePuy ACE Composite Locking Nut; orthopedic fixation accessory. Device consists of 10mm hex nut; composite construction of UHMW polyethylene nut with integrated titanium washer. Used in surgical settings by orthopedic surgeons. Functions as mating part to bone screws; washer increases surface area to distribute load against bone, aiding fixation in osteoporotic bone. Surgeon manually applies nut to screw; torque characteristics allow identification of seating against bone to prevent over-torquing. Benefits patient by improving fixation stability in compromised bone.

Clinical Evidence

Bench testing only. Test Report ET 63-001 demonstrated that ultimate torque is approximately 10 times insertion torque, allowing surgeons to identify when the nut is seated against bone to prevent accidental over-torque.

Technological Characteristics

10mm hex nut; composite construction of UHMW polyethylene and titanium washer. Mechanical fixation device. No software or energy source.

Indications for Use

Indicated for use with cortical bone screws, intramedullary nails as locking bolts, and screws with plates, specifically where extra purchase in the far cortex is required.

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

• DePuy ACE Nut for Cortical Bone Screws (K874669)
• DePuy ACE Washer (K895107)

Submission Summary (Full Text)

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OCT 2 6 1998

K983265

### 510(k) SUMMARY

NAME OF FIRM:

510(k) CONTACT PERSON:

TRADE NAME:

COMMON NAME:

CLASSIFICATION:

DePuy ACE Medical Company 2260 East El Segundo Boulevard El Segundo, CA 90245

Kathleen Dragovich Regulatory Affairs Specialist DePuy ACE Medical Company

DePuy ACE Composite Locking Nut

Nut, Orthopedic

87HTN

888.3030 Single/multiple component metallic Bone fixation appliances and accessories. Class II

### DEVICE CODE:

# SUBSTANTIALLY EQUIVALENT DEVICES:

DePuy ACE Nut for Cortical Bone Screw DePuy ACE Washer

#### INTENDED USE:

The DePuy ACE Composite Locking Nut is used as follows:

Cortical bone screws (alone) Intramedullary nails as locking bolts Screws with plates Where extra purchase in far cortex is required

# DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The device is a nut with a 10mm hex. This nut is made from a composite of a UHMW Polyethylene nut with a built-in Titanium washer. The washer will aid in fixation in osteoporotic bone by helping to distribute the load against the bone.

The DePuy ACE Composite Locking Nut is a combination of the DePuy ACE Nut for Cortical Bone Screws which received clearance under 510(k) K874669 and the DePuy ACE Washer which received clearance under 510(k) K895107. The function of the DePuy ACE Composite Locking Nut is a combination of both the nut and the washer: to act as the mating part to a screw for better fixation and to increase the surface under the nut to help distribute the load against the surface of the bone.

Testing has shown that the ultimate torque is approximately 10 times that of the insertion torque; therefore, the nut can be applied without rounding the nut. This distinct difference indicates that upon insertion and advancement of the surgeon will be able to clearly identify that the nut is seated against the bone prior to accidental over-torque of the nut. (See Test Report ET 63-001 in Exhibit IV.)

Based on the above information, DePuy ACE believes that the DePuy ACE Composite Locking Nut is substantially equivalent to the DePuy ACE Nut for Cortical Bone Screw and the DePuy ACE Washer.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 1998

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

Re: K983265 Trade Name: DePuy ACE Composite Locking Nut Requlatory Class: II Product Code: HTN September 15, 1998 Dated: September 17, 1998 Received:

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, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 regulatory 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,

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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Image /page/3/Picture/0 description: The image shows the logo for DePuy ACE. The logo consists of a black circle followed by the text "DePuy ACE" in a bold, sans-serif font. The letters are all capitalized, and the "TM" symbol is present in the bottom right corner of the "E". The logo is simple and modern, and the black color gives it a sense of authority.

510(k) Number (if known)

Device Name: DePuy ACE Composite Locking Nut

Indication for Use:

The DePuy ACE Composite Locking Nut is used as follows:

Cortical bone screws (alone) Intramedullary nails as locking bolts Screws with plates Where extra purchase in far cortex is required

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109)

OR

510(k) Number

Over-The-Counter

(Division Sign-Off)
Division of General Restorative Devices