TRIFLANGE II ACETABULAR CUP SYSTEM

K040383 · DePuy Orthopaedics, Inc. · LPH · May 12, 2004 · Orthopedic

Device Facts

• Record ID: K040383
• Device Name: TRIFLANGE II ACETABULAR CUP SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: May 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TriFlange II Acetabular Cup System is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.

Device Story

Patient-specific acetabular cup system designed to match individual patient anatomy; used in total hip arthroplasty to resurface acetabular socket. System comprises porous-coated acetabular cup with three patient-specific flanges (illial, ischial, pubic) to reinforce weak acetabula. Fixed via titanium bone screws through flange holes. Used in cementless applications with modular liners. Intended to increase patient mobility and reduce pain by replacing damaged hip joint articulation. Operated by orthopedic surgeons in clinical/surgical settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

Porous-coated acetabular cup with three patient-specific flanges (illial, ischial, pubic). Materials include metal/polymer/metal components. Fixation via titanium bone screws. Cementless application. Non-mechanical/non-software device.

Indications for Use

Indicated for patients requiring total hip arthroplasty with sufficient sound bone to support components. Conditions include: severe pain/disability from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous hip surgery (reconstruction, fixation, arthrodesis, hemiarthroplasty, surface replacement, or total hip replacement); and certain cases of ankylosis.

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

• DePuy TriFlange Acetabular Cup System (K001277)
• DePuy Pinnacle® Acetabular System (K001534)

Submission Summary (Full Text)

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MAY 1 2 2004

040383
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## 510(k) Summary

| Name of Sponsor: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No. 1818910 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Dina L. Weissman, J.D.<br>Legal Consultant, Regulatory Affairs<br>Phone: [phone]<br>FAX: [phone] |
| Trade Name: | TriFlange II Acetabular Cup System |
| Common Name: | Patient specific flanged acetabular cup system |
| Classification: | Class II; 21 CFR 888.3858 Hip joint<br>metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis and |
| | Unclassified; prosthesis, hip, semi-constrained,<br>uncemented, metal/polymer, non-porous, calicum-<br>phosphate |
| Device Product Code: | Code: 87LPH<br>Code: 87 MEH |
| Substantially Equivalent Device: | DePuy TriFlange Acetabular Cup System K001277<br>DePuy Pinnacle® Acetabular System K001534 |
| Device Description: | The patient specific TriFlange II Acetabular Cup System<br>is an acetabular cup system designed and manufactured to<br>match the individual patient's anatomy. The system<br>consists of a porous coated acetabular cup with three<br>patient specific illial, ischial and pubic flanges added to<br>reinforce weak acetabula. The device may be fixed in<br>place with titanium bone screws of various lengths<br>through a variety of screw holes in the flanges. |
| Intended use: | The TriFlange II Acetabular Cup System is intended to be<br>used with modular liners to resurface the acetabular<br>socket in cementless application during total hip<br>arthroplasty. |
| Indications for use: | The system is intended to be used with modular liners<br>to resurface the acetabular socket in cementless<br>application during total hip arthroasty. |

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040583
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Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Total hip replacement is indicated in the following conditions:

- 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or 3. neck.
- Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarthroplasty, wor surface replacement arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

The TriFlange Acetabular Cup System with patient specific flanges is substantially equivalent to the currently marketed TriFlange Acetabular Cup System (K001277) and the DePuy Pinnacle Acetabular Cup (K001534).

Substantial equivalence:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2004

Ms. Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K040383

Trade/Device Name: TriFlange II Acetabular Cup System Regulation Number: 21 CFR 888.3858 Unclassified Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Prosthesis, hip, semi-constrained, uncemented, metal/polymer, nonporous, calcium-phosphate Regulatory Class: II Product Code: LPH, MEH Dated: February 16, 2004 Received: February 17, 2004

Dear Ms. Weissman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 or any Federal statutes and regulations administered by other Federal agencies. You must

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## Page 2 - Ms. Dina L. Weissman, J.D.

comply with all the Act's requirements, including, but not 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html

Sincerely yours.

sincerely yours,

Mark N Millerson

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

Enclosure

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## Indications for Use

510(k) Number (if known): Device Name:

Indications for Use:

The system is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Total hip replacement is indicated in the following conditions:

- A severely painful and/or disabled joint from osteoarthritis, traumatic l . arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- 3. Acute traumatic fracture of the femoral head or neck.
- 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- న్న Certain cases of ankylosis.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(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)

*for* Mark N. Melkerson

(Division Sign-Off)

(Posted November 13, 2003)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K040383 |
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