DEPUY DURALOC ACETABULAR CUP SYSTEM

K972596 · Depuy, Inc. · LPH · Nov 12, 1997 · Orthopedic

Device Facts

• Record ID: K972596
• Device Name: DEPUY DURALOC ACETABULAR CUP SYSTEM
• Applicant: Depuy, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Nov 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Duraloc Acetabular Cup Liners are intended to be used with the DePuy Duraloc metal acetabular shells to resurface the acetabular socket in cemented or cementless total hip replacement

Device Story

Polyethylene acetabular cup liners; 28mm or 32mm inner diameters; neutral or 10° lip options. Designed for use with Duraloc metal acetabular shells (48-74mm outer diameters). Locked into metal shells via metal wire locking ring. Used by orthopedic surgeons in total hip arthroplasty to resurface acetabular socket. Provides bearing surface for hip joint replacement. Manufactured from crosslinked polyethylene for increased oxidation resistance compared to standard gamma-sterilized UHMWPE.

Clinical Evidence

No clinical data provided; substantial equivalence based on design identity and material property comparisons.

Technological Characteristics

Crosslinked polyethylene acetabular liners; metal wire locking mechanism; 28mm/32mm ID; 48-74mm OD compatibility. Designed for cemented or cementless total hip arthroplasty. Mechanical properties comparable to standard UHMWPE with enhanced oxidation resistance.

Indications for Use

Indicated for use with Duraloc System Acetabular Cups to resurface the acetabular socket in cemented or cementless total hip arthroplasty.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Modified DePuy Acetabular Cup System
• DePuy Modified AML+ Acetabular Cup System

Submission Summary (Full Text)

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| NAME OF FIRM: | DePuy Inc.<br>P.O. Box 988<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988 |
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| 510(k) CONTACT: | Cheryl Hastings<br>Manager, Clinical Affairs |
| TRADE NAME: | DePuy Duraloc® Acetabular Cup System |
| COMMON NAME: | Acetabular Cup Prosthesis |
| CLASSIFICATION: | 888.3358 Hip joint metal/polymer semi-constrained<br>cementless prosthesis |
| DEVICE PRODUCT CODE: | 87 LPH |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | Modified DePuy Acetabular Cup System |

DePuy Modified AML+ Acetabular Cup System

## DEVICE DESCRIPTION AND INTENDED USE:

The subject DePuy Duraloc Acetabular Cup Liners are polyethylene acetabular cup liners which are available with 28mm or 32mm inner diameters, and with a neutral or a 10° lip. The 28mm liners are available in sizes to fit Duraloc metal acctabular shells with outer diameters of 48-74mm. The 32mm liners are available in sizes to fit Duraloc metal acetabular shells with outer diameters of 52-74mm. The Duraloc polyethylene liners are locked into the Duraloc metal shells with a metal wire locking ring which is supplied with the metal shells. The subject polyethylene liners are identical in design to the acetabular cup liners cleared with the Modified DePuy Acetabular Cup System and the DePuy Modified AML+ Acetabular Cup System.

The only difference between the subject Duraloc polyethylene liners and those that have been previously cleared by FDA is that the subject liners are manufactured from crosslinked polyethylene which has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to oxidation compared to gamma radiation sterilized standard UHMWPE.

The DePuy Duraloc Acetabular Cup Liners are intended to be used with the DePuy Duraloc metal acetabular shells to resurface the acetabular socket in cemented or cementless total hip replacement

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cheryl Hastings Manager, Clinical Affairs DePuy Inc. P.O. Box 988 700 Orthopaedic Drive 46581-0988 Warsaw, Indiana

NOV 1 2 1997

K972596 Re: DePuy Duraloc® Acetabular Cup System Trade Name: Regulatory Class: II Product Codes: LPH and JDI Dated: October 22, 1997 Received: October 23, 1997

Dear Ms. Hastings:

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, Druq, 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 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ 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 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 - Ms. Cheryl Hastings

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,

follyfe

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) _K972596

Device Name DePuy Duraloc Acetabular Cup Liners

Indications for Use:

The DePuy Duraloc Acetabular Cup Liners are intended to be used with the Duraloc System Acetabular Cups to resurface the acetabular socket in cemented or cementless total hip arthroplasty.

Concurrence of CDRH, Office of Device Evaluation

bcada
(Division Sign-Off)

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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K972596

Prescription Use _ X

OR (Per 21 CFR 801.109) Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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