TITAN POROCOAT HIP PROSTHESIS

K001991 · DePuy Orthopaedics, Inc. · LPH · Aug 25, 2000 · Orthopedic

Device Facts

• Record ID: K001991
• Device Name: TITAN POROCOAT HIP PROSTHESIS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Aug 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Titan Porocoat Hip Prosthesis is a collarless, tapered, press-fit femoral stem for total hip arthroplasty. Device manufactured from Ti-6Al-4V titanium alloy with sintered commercially pure titanium bead porous coating (Porocoat) to facilitate biological fixation via tissue ingrowth. Available in 11 body sizes (6mm to 18mm diameter) with two offset options per size. Intended for cementless implantation by orthopedic surgeons to replace damaged hip joint articulation, reduce pain, and improve patient mobility. Device functions as a mechanical structural replacement for the femoral head/neck.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Ti-6Al-4V titanium alloy stem with sintered commercially pure titanium bead porous coating. Design: Collarless, tapered, press-fit femoral stem. Dimensions: 11 sizes, 6-18mm diameter, two offsets per size. Fixation: Cementless, biological tissue ingrowth.

Indications for Use

Indicated for patients requiring total hip replacement due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement, or total hip replacement), or ankylosis. Indicated for cementless use and fixation via biological tissue ingrowth.

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

• UNI-ROM Femoral Hip Stem (K974331)
• Stability Hip Femoral Component with Porocoat (K934457)
• Vision AML Hip Prosthesis (K953694)

Submission Summary (Full Text)

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AUG 25 2000
510(k) Summary
K001551
12.10/2

**Name of Sponsor:**
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Est. Reg. No. 1818910

**510(k) Contact:**
Marcia J. Arentz
Senior Regulatory Associate
Phone: [phone]
FAX: [phone]

**Trade Name:**
Titan™ Porocoat® Hip Prosthesis

**Common Name:**
Total Hip Joint Replacement Prosthesis with porous coating

**Classification:**
Class II Device per 21 CFR 888.3358:
Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis

**Device Product Code:**
Code: 87LPH Prosthesis Hip Semi-constrained, Metal/Polymer, Porous Uncemented
No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems.

**Substantially Equivalent Device:**
UNI-ROM Femoral Hip Stem K974331
Stability Hip Femoral Component with Porocoat K934457
Vision AML Hip Prosthesis K953694

**Device Descriptions:**
The Titan Porous Hip is a collarless, titanium, tapered, press-fit femoral stem. The hip stem is manufactured from Titanium (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat®) applied to the stem. The hip stem consists of 11 body sizes ranging in diameter from 6mm to 18mm with each body size having two offset options.

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K001991
p. 3 of 2

# 510(k) Summary (continued)

## Intended use:

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.

## Indications for use:

Total hip replacement is indicated in the following conditions:

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

## Substantial equivalence:

The Titan Porocoat Hip Prosthesis has the same intended use and basic design as the predicate devices and is therefore substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

AUG 25 2000

Ms. Marcia J. Arentz
Senior Regulatory Associate
DePuy Orthopaedics, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988

Re: K001991
Trade Name: Titan™ Porocoat® Hip Prosthesis
Regulatory Class: II
Product Code: LPH
Dated: June 26, 2000
Received: June 29, 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,

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): K001991

Device Name: Titan™ Porocoat® Hip Prosthesis

## Indications for Use:

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.
2. Avascular necrosis of the femoral head.
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.
5. Certain cases of ankylosis.

The Titan Porocoat® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K001991

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use

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