TRIFLANGE ACETABULAR CUP SYSTEM

K001277 · DePuy Orthopaedics, Inc. · LPH · Jun 23, 2000 · Orthopedic

Device Facts

• Record ID: K001277
• Device Name: TRIFLANGE ACETABULAR CUP SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jun 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

TriFlange™ Acetabular Cup System is a patient-specific hip implant designed for cementless total hip arthroplasty. The device consists of a porous-coated Duraloc acetabular cup integrated with three patient-specific flanges (illial, ischial, pubic) to reinforce weak acetabular bone. The system is manufactured to match individual patient anatomy. During surgery, the device is implanted into the acetabulum and fixed using titanium bone screws through flange holes. It is used with Duraloc UHMWPE liners. The device provides structural support for patients with compromised acetabular bone stock, facilitating hip joint reconstruction and rehabilitation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Acetabular cup system featuring porous-coated Duraloc cup and patient-specific titanium flanges. Fixation via titanium bone screws. Designed for cementless application. Compatible with UHMWPE liners.

Indications for Use

Indicated for skeletally mature individuals undergoing primary or revision total hip arthroplasty for hip rehabilitation due to disease, deformity, or trauma, including non-inflammatory degenerative joint disease (NIDJD), osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, and diastrophic variant.

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 Duraloc® 400 Acetabular Cup (K952740)
• DePuy Protrusio Cage (K962007)
• Biomet Patient Matched Flanged Acetabular Component (K983035)
• Sulzer Inter-Op™ HA Porous Acetabular System (K972393)
• Zimmer Harris/Galante Porous Hip Prosthesis With HA/TCP Coating (K980711)

Submission Summary (Full Text)

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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 |
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| 510(k) Contact: | Marcia J. Arentz<br>Senior Regulatory Associate<br>Phone: [phone]<br>FAX: [phone] |
| Trade Name: | TriFlange™ Acetabular Cup System |
| Common Name: | Patient specific flanged acetabular cup system |
| Classification: | Class II |
| Device Product Code: | Code: 87LPH Prosthesis, Hip, Semi-Constrained,<br>Metal/Polymer, Porous uncemented<br>Code: 87 MEH Prosthesis, Hip Semi-Constrained,<br>Uncemented, Metal/Polymer, Non-porous, Calcium-<br>phosphate |
| Substantially Equivalent Device: | DePuy Duraloc® 400 Acetabular Cup................................ K952740<br>DePuy Protrusio Cage........................................................ K962007<br>Biomet Patient Matched Flanged<br>Acetabular Component ................................................. K983035<br>Sulzer Inter-Op™ HA Porous<br>Acetabular System ......................................................... K972393<br>Zimmer Harris/Galante Porous........................................ K980711<br>Hip Prosthesis With HA/TCP Coating |
| Device Description: | The patient specific TriFlange™ 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 Duraloc acetabular cup with<br>three patient specific illial, ischial and pubic flanges<br>added to reinforce weak acetabula similar to the Protrusio<br>Cage. The device may be fixed in place with titanium<br>bone screws of various lengths through a variety of screw<br>holes in the flanges. |
| Intended use: | The TriFlange™ Acetabular Cup System is intended to be<br>used with the Duraloc® UHMWPE liners to resurface the<br>acetabular socket in cementless application during total<br>hip arthroplasty. |

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Indications for use:

Substantial equivalence:

The TriFlange™ Acetabular Cup System is indicated for use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged by disease, deformity, or trauma including non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.

The TriFlange™ Acetabular Cup System with patient specific flanges is substantially equivalent to the currently marketed DePuy Duraloc® Acetabular Cup (K952740), the DePuy Protrusio Cage (K962007) the Biomet Patient Matched Flanged Acetabular Component (K983035), the Sulzer Inter-OpTM HA Porous Acetabular System (K972393) and the Zimmer Harris/Galante Porous Hip Prosthesis With HA/TCP coating (K980711).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUN 2 3 2000

Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K001277

Trade Name: TriFlange™ Acetabular Cup System Regulatory Class: II Product Code: LPH, MEH Dated: April 20, 2000 Received: April 21, 2000

Dear Ms. Arentz:

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 control provisions of the Act. The general control 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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.

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.

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Page 2 - Ms. Marcia J. Arentz

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,

Duna R. lochner -

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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## 510(k) Number (if known): kooj 377 ---

### Device Name: TriFlange™ Acetabular Cup System

### Indications for Use:

The TriFlange™ Acetabular Cup System is intended to be used with the Duraloc polyethylene liners to resurface the acetabular socket in cementless application during total hip arthroplasty. The device is indicated for use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged by disease, deformity, or trauma including non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.

Concurrence of CDRH, Office of Device Evaluation

D:une R. Lochner

Division Sign-O (Division Sign-On)
Division of General Restorative Devices

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Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use10(k) Number_KQQ12

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