PINNACLE CONSTRAINED ACETABULAR LINERS

K052079 · DePuy Orthopaedics, Inc. · KWZ · Oct 21, 2005 · Orthopedic

Device Facts

• Record ID: K052079
• Device Name: PINNACLE CONSTRAINED ACETABULAR LINERS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWZ · Orthopedic
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject Pinnacle" Constrained Acetabular Liner is intended to be used with the DePuy Pinnacle" metal acetabular shells and Self-centering™ (bipolar) heads to resurface the acctabular socket in cementless total hip arthroplasty.

Device Story

Pinnacle Constrained Acetabular Liner is a modular hip prosthesis component. Device consists of UHMWPE liner and titanium alloy (Ti-6Al-4V) constraining ring. Liner locks into porous-coated titanium hemispherical shell. Mechanism provides >180 degrees femoral head capture to mechanically constrain femoral head within liner ID. Intended for use with Self-Centering (bipolar) femoral heads (40mm-44mm). Used in OR by orthopedic surgeons during total hip arthroplasty. Provides stability for patients at high risk of dislocation; prevents femoral head disarticulation from acetabular cup. Benefits include reduced risk of recurrent dislocation in high-risk populations.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and manufacturing similarities to predicate devices.

Technological Characteristics

Materials: UHMWPE liner, Ti-6Al-4V titanium alloy shell and locking ring. Design: Hemispherical, modular, cementless. Constraining mechanism: Titanium ring providing >180 degrees femoral head capture. Dimensions: 62mm-76mm OD, 40mm-44mm ID. Connectivity: None. Sterilization: Not specified.

Indications for Use

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

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

• Osteonics Constrained Acetabular Inserts
• DePuy Pinnacle® Constrained Acetabular Liners

Reference Devices

• Pinnacle Acetabular Liners (K043058)

Submission Summary (Full Text)

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K052079

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OCT 2 1 2005

# 510(k) SUMMARY

Submitted July 28, 2005

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## DePuy Orthopaedics, Inc.

P0 Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
USA Tel: [phone]

| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46580 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Keli K. Hankee<br>Clinical Research Associate<br>DePuy Orthopaedics, Inc.<br>PO Box 988<br>700 Orthopaedic Drive<br>Warsaw, IN 46580 |
| 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: | Osteonics Constrained Acetabular Inserts<br>DePuy Pinnacle ^® Constrained Acetabular Liners |

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### 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 Acetabular 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 liner. The UHMWPE liner is held in the metal shell by means of a titanium locking ring.

The subject Pinnacle" Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized face-changing orientation. The liners have inner diameters (ID) intended for use with Self-Centering (bipolar) femoral heads within the 40mm-44mm size range. The 62mm-76mm outer diameters (ODs) are geometrically the same as other smaller OD Pinnacle Acetabular Liners cleared in K043058.

#### INDICATIONS AND INTENDED USE:

#### Indications:

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.

#### Intended Use:

The subject Pinnacle" Constrained Acetabular Liner is intended to be used with the DePuy Pinnacle" metal acetabular shells and Self-centering™ (bipolar) heads to resurface the acctabular socket in cementless total hip arthroplasty.

#### Basis of Substantial Equivalence:

The DePuy Pinnacle" Constrained Acetabular 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 is identical to the DePuy predicate and does not raise any new issues of safety or effectiveness.

DePuy believes that the DePuy Pinnacle" Constrained Acetabular Liner is substantially equivalent to the previously cleared and approved devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 2005

Keli K. Hankee Clinical Research Associate DePuy Orthopaedics, Inc PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K052079

R032079
Trade/Device Name: Pinnacle® Constrained Acetabular Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: July 29, 2005 Received: August 02, 2005

Dear Ms. Hankee:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreative to togens and the Medical Device Amendments, or to conninered pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de necs that have been resuire approval of a premarket approval application (PMA). and Costine Tree (11ct) that to hovice, subject to the general controls provisions of the Act. The r ou may, dicrerere, mainer of the Act include requirements for annual registration, listing of general controls proving practice, 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 exablical controls. Existing major regulations affecting your device can may or subject to back as a substions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I DA has Intact and regulations administered by other Federal agencies. You must or any I Gaetar Buttated and states and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in and quand of of of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Keli K. Hankee

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you've ought finding of substantial equivalence of your device to a legally prematication: "The PDF Intelling of easification 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 If you desire specific advice ion your as [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

summitry,

for Mark N. Mollen

Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K082079

#### Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ 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 I milace - Constramed Hocatients at high risk of hip dislocation due to a history of prior prosulesis in primary of for 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.

Over-The-Counter Use Prescription Use _ 人 AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

(Posted November 13, 2003)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K052079