DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER

K983491 · DePuy Orthopaedics, Inc. · LPH · Dec 2, 1998 · Orthopedic

Device Facts

• Record ID: K983491
• Device Name: DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Dec 2, 1998
• 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 to be used with the DePuy Duraloc Acetabular Cup System's metal acetabular shells to resurface the acetabular socket in cemented or cementless total hip arthroplasty.

Device Story

Device consists of UHMWPE acetabular cup liners designed for use with Duraloc metal acetabular shells; available in standard and Charnley Bore (CB) designs; neutral or 10° lip styles; 22.225mm inner diameter; fits shells with 48-74mm outer diameters. Liners lock into metal shells via metal wire locking ring. Used by orthopedic surgeons in clinical settings during total hip arthroplasty to provide articulating surface for femoral head. Benefits include restoration of hip joint function and stability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: UHMWPE (ASTM F-648). Design: Standard and Charnley Bore (CB) styles with neutral or 10° lip. Dimensions: 22.225mm inner diameter; 48-74mm outer diameter. Locking mechanism: Metal wire ring. Non-electronic, mechanical orthopedic implant.

Indications for Use

Indicated for patients undergoing cemented or cementless total hip arthroplasty requiring acetabular socket resurfacing.

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 (K900832)
• Modified AML® + Acetabular Cup Prosthesis (K900891)
• DePuy Duraloc® Cementless Acetabular Cup System (K961186)

Submission Summary (Full Text)

{0}------------------------------------------------

2 1998 DEC

K983499/

## SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF SPONSOR: | DePuy®, Inc.<br>P.O. Box 988<br>Warsaw, Indiana 46581-0988 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Sally Foust<br>Senior Regulatory Submissions Associate<br>DePuy Orthopaedics, Inc.<br>1 [phone]; FAX: [phone]<br>E-Mail: [e-mail] |
| TRADE NAME: | DePuy Duraloc® Acetabular Cup System - Enduron<br>Liner |
| COMMON NAME: | Hip Cup Liner |
| CLASSIFICATION: | 888..3358 - Hip joint metal/polymer semi-constrained<br>cementless prosthesis |

DEVICE PRODUCT CODE: 87 LPH and JDM

## SUBSTANTIALLY EQUIVALENT DEVICE:

Modified DePuy Acetabular Cup System (K900832) Modified AML® + Acetabular Cup Prosthesis (K900891) DePuy Duraloc® Cementless Acetabular Cup System (K961186)

# DEVICE DESCRIPTION AND INTENDED USE:

The DePuy Duraloc Acetabular Liners are manufactured from ultra high molecular weight polyethylene (UHMWPE) and are available in two designs. standard and Charnley Bore (CB), Both designs are available in two styles, a neutral and 10° lip, with an inner diameter (I.D.) of 22.225mm and are available in sizes to fit Duraloc metal acetabular shells with outer diameters of 48mm-74mm. The Duraloc liners are locked into the Duraloc metal acetabular shells with a metal wire locking ring supplied with the shells.

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

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The intended use as described in its labeling, fundamental scientific technology, and material of the 22.225mm I.D. UHMWPE liners of the DePuy Duraloc Acetabular Cup System has not changed from the cleared (K900832, K900891, and K961186) 22.225mm, 26mm, 28mm and 32mm I.D. UHMWPE liners of the DePuy Duraloc Acetabular Cup System.

Image /page/0/Picture/12 description: The image shows the number 000005. The numbers are in a simple, sans-serif font. The numbers are all black and are on a white background. The number 5 is slightly tilted to the right.

{1}------------------------------------------------

The standard liners are identical in design to the previously cleared (K900832. K900891) DePuv Duraloc acetabular cup liners except for the smaller (22.225mm) inner diameter. The standard liners are also identical in design to the previously cleared (K961186) DePuy Duraloc Bantam acetabular cup liners except the subject liners are available in larger sizes to fit Duraloc metal acetabular shells with outer diameters of 48mm-74mm.

The Charnley Bore (CB) liners are identical in design to the previously cleared (K900832, K900891) DePuy Duraloc acetabular cup liners except for the smaller (22,225mm) inner diameter and the additional 2mm of polyethylene added on the face of the liner wall. The Charnley Bore (CB) liners are also identical in design to the previously cleared (K961186) DePuy Duraloc Bantam acetabular cup liners except that the subject liners are available in larger sizes to fit Duraloc metal acetabular shells with outer diameters of 48-74mm and have an additional 2mm of polyethylene added on the face of the liner wall.

Based on similarities of design, material and intended use, DePuy believes that the subject DePuy Duraloc Acetabular Liners are substantially equivalent to the cleared liners of the DePuy Duraloc Acetabular Cup System.

| | Current<br>Submission | Modified<br>DePuy<br>Acetabular Cup<br>System | Modified AML<br>Acetabular Cup<br>Prosthesis | DePuy Duraloc<br>Cementless<br>Acetabular Cup<br>System |
|----------------------|---------------------------------------|-----------------------------------------------|----------------------------------------------|---------------------------------------------------------|
| | | K900832 | K900891 | K961186 |
| Materials | UHMWPE<br>ASTM F-648 | UHMWPE<br>ASTM F-648 | UHMWPE<br>ASTM F-648 | UHMWPE<br>ASTM F-648 |
| Inner<br>Diameters | 22.225mm | 26, 28<br>and 32mm | 26, 28<br>and 32mm | 22.225, 26<br>and 28mm |
| Outer<br>Diameters | 48-74mm | 46-74mm | 46-74mm | 38-46mm |
| Design | Standard and<br>Charnley Bore<br>(CB) | Standard | Standard | Standard |
| Lip | Neutral<br>and 10° | Neutral,<br>10° and 20° | Neutral,<br>10° and 20° | 10° |
| Locking<br>Mechanism | Metal Wire Ring | Metal Wire Ring | Metal Wire Ring | Metal Wire Ring |

Refer to the following table for a summary of the similarities:

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1998 DEC

Ms. Sally Foust Regulatory Submissions Associate DePuy, Inc. P.O. Box 988 700 Orthopedic Drive Warsaw, Indiana 46581-0988

Re: K983491 DePuy Duraloc® Acetabular Trade Name: Cup System Euduron Liner Regulatory Class: II Product Codes: LPH and JDM Dated: October 2, 1998 October 5, 1998 Received:

Dear Ms. Foust:

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 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 Regulations, 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 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 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.

{3}------------------------------------------------

#### Page 2 - Ms. Sally Foust

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,

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

Enclosure

{4}------------------------------------------------

510(k) Number (if known)_K983491

Device Name: DePuy Duraloc Acetabular Cup Liners: Additional Liners

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation

OR

Prescription Use_ X (Per 21 CFR 801.109)

Over-The-Counter Use_

Division Sign Off

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K983491

..