PINNACLE CONSTRAINED ACETABULAR LINERS

K043058 · Depuy, Inc. · KWZ · Mar 14, 2005 · Orthopedic

Device Facts

• Record ID: K043058
• Device Name: PINNACLE CONSTRAINED ACETABULAR LINERS
• Applicant: Depuy, Inc.
• Product Code: KWZ · Orthopedic
• Decision Date: Mar 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject Constrained Liner is intended to be used with the DePuy Pinnacle™ metal acetabular shells, and modular femoral heads to resurface the acetabular socket in cementless total hip arthroplasty. The Pinnacle® Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. The Pinnacle® Constrained Acetabular Liner is indicated for use with the Pinnacle® Acetabular Cup in cementless application.

Device Story

Pinnacle Constrained Acetabular Liner is a modular hip prosthesis component; replaces natural articular surface. Device consists of ultra-high molecular weight polyethylene (UHMWPE) liner; titanium alloy (Ti-6Al-4V) constraining ring; titanium locking ring. Liner locks into porous-coated hemispherical titanium shell. Mechanism: provides >180 degrees femoral head capture to mechanically constrain femoral head within liner ID. Used in cementless total hip arthroplasty; intended for patients at high risk of dislocation. Surgeon selects appropriate size (28mm-36mm femoral head; 48mm-60mm shell) to restore joint stability. Output is a constrained articulation surface; reduces risk of post-operative hip dislocation. Used in clinical/OR settings by orthopedic surgeons.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarities to predicate devices.

Technological Characteristics

Materials: UHMWPE liner, Ti-6Al-4V titanium alloy shell and constraining ring. Design: Modular, hemispherical, cementless, constrained acetabular liner. Sizes: 28mm-36mm femoral head compatibility; 48mm-60mm shell compatibility. Mechanism: Mechanical constraint via >180 degree femoral head capture and titanium locking ring.

Indications for Use

Indicated for primary or revision total hip arthroplasty patients at high risk of dislocation due to prior dislocation, bone loss, joint/soft tissue laxity, neuromuscular disease, or intraoperative instability. Used with Pinnacle Acetabular Cup in cementless applications.

Regulatory Classification

Identification

A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”

Predicate Devices

• Biomet RingLoc II Constrained Liners
• Biomet Freedom Constrained Liners
• DePuy SROM Poly-Dial Acetabular Cup System Constrained Liners
• DePuy Duraloc Acetabular Cup System Constrained Liners

Submission Summary (Full Text)

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

K043058 page 142

MAR 1 4 2005

| 510(k) SUMMARY | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46580 |
| 510(K) CONTACT: | Natalie S. Heck<br>Manager, Regulatory Affairs<br>DePuy Orthopaedics, Inc.<br>PO Box 988<br>700 Orthopaedic Drive<br>Warsaw, IN 46581-0988 |
| TRADE NAME: | DePuy Pinnacle ^® Constrained Acetabular Liners |
| COMMON NAME: | Acetabular Cup Liner |
| CLASSIFICATION: | Class II, per 21 CFR, 888.3310<br>Hip joint metal/polymer/ metal, constrained, cemented or<br>uncemented prosthesis |
| DEVICE PRODUCT CODE: | 87 KWZ |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | Biomet RingLoc II Constrained Liners<br>Biomet Freedom Constrained Liners<br>DePuy SROM ^™ Poly-Dial Acetabular Cup System<br>Constrained Liners<br>DePuy Duraloc ^® Acetabular Cup System Constrained<br>Liners |

## DEVICE DESCRIPTION:

The Pinnacle® Constrained Acetabular Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-6Al-4V). The liner component articulates with a metal femoral head of an appropriate diameter.

The Pinnacle® Constrained Liner mechanically constrains the femoral head within the ID of the liner by providing greater than 180 degrees femoral head capture combined with a titanium constraining ring which fits over the opening diameter of the UHMWPE liner is held in the metal shell by means of a titanium locking ring.

The subject Pinnacle® Constrained Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized face-changing orientation. The liners have inner diameters (ID)

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

page of

intended for use with modular femoral heads within the 28mm-36mm size range. The outer mended for assemmer metrically the same as other Pinnacle Acetabular Liners, in a 48mm-60mm size range offering.

## INDICATIONS AND INTENDED USE:

## Indications:

The Pinnacle" Constrained Polyethylene Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

The Pinnacle™ Constrained Liner is indicated for use with the Pinnacle® Acetabular Cup in cementless application.

#### Intended Use:

The subject Constrained Liner is intended to be used with the DePuy Pinnacle™ metal acetabular shells, and modular femoral heads to resurface the acetabular socket in cementless total hip arthroplasty.

## Basis of Substantial Equivalence:

The DePuy Pinnacle" Constrained Polyethylene Liner (lateralized neutral and lateralized facechanging), described in this submission is substantially equivalent to the predicate devices based on similarities in design, intended use, material and manufacturing methods. The design, while not identical to the predicates, does not raise any new issues of safety or effectiveness.

DePuy believes that the DePuy Pinnacle® Constrained liner is substantially equivalent to the previously cleared and approved devices.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is enclosed in a circle with the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2005

Ms. Natalie S. Heck Manager, Regulatory Affairs Depuy Orthopedics, Inc. P.O. Box 988 700 Orthopedic Drive Warsaw, Indiana 46581

Re: K043058

K043038
Trade/Device Name: Pinnacle® Constrained Acetabular Liners Regulation Number: 21 CFR 888.3310 Regulation Number: 21 CFN 866.531v
Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: February 14, 2005 Received: February 16, 2005

Dear Ms. Heck:

We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your Section 910(x) premained is substantially equivalent (for the indications
referenced above and have determined the device is substantial in interests to felerenced above and nave decemblied by marketed predicate devices marketed in interstate for use stated in the encrosule for regary manated to of the Medical Device Amendments, or to commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provision (DMA) devices that have been recalssined in acco.uanno will of a premarket approval application (PMA). and COSMECIC ACT (Act) that do not requent appt to the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls pr I ou may, mercere, market the as ress, and include requirements for annual registration, listing of general controls provisions a castice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 above) this existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and be found in the Code of Federal Reg. ations, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Outs ocements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I 271 S resulties on a button with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any I cochar stututes and regulations, but not limited to: registration and listing (21 Comply with an the Fee breakens, and 801); good manufacturing practice requirements as set CITY at 607), adomig (21 OF RT LEF 007), good if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

# Page 2 - Ms. Natalie S. Heck

This letter will allow you to begin marketing your device as described in your Section 510(k)
10 legally and the collection of the same interest of your device to a legally This letter will allow you to begin marketing your aver as a legally premarket notification. The PDA Inding of substantial equivation .
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), please
rs of the many of the support of the and and and personation requilation e If you desire specific advice ior your de need on on. Also, please note the regulation entitled.
contact the Office of Compliance if [phone]. Also, plcase note the re contact the Uffice of Compliance at (240) 2/10 of 20:1 Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Ast may be oblained from the "Misbranding by reference to premarket nothlities under the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address (600) 050-26da.gov/cdrh/industry/support/index.html

Sincerely yours,

R. Mark A. Milliken

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use 510(k) Number (if known): _ K o 43 05 8 Device Name: __Pinnacle® Constrained Acetabular Liner_________________________________________________________________________________________________________________________

Indications for Use:

The Pinnacle® Constrained Acetabular Liner is indicated for use as a component of a total hip The Pimacle" Constrance Asetabular Liner is mislocation due to a history of prior prosthesis in primary of revision patients at ingil fisk of the case or intraoperative instability.

The Pinnacle® Constrained Acetabular Liner is indicated for use with the Pinnacle® Acetabular Cup in cementless application.

| Prescription Use | X (Part 21 CFR 801 Subpart D) |
|----------------------|-------------------------------|
| | AND/OR |
| Over-The-Counter Use | No (21 CFR 807 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K043058 |
|---------------|----------------------------|
| | (Posted November 13, 2003) |

| Page | 1 of 1 |
|------|--------|
|------|--------|

ਹੈ।