CORAIL AMT HIP PROSTHESIS

K042992 · DePuy Orthopaedics, Inc. · LZO · Feb 11, 2005 · Orthopedic

Device Facts

• Record ID: K042992
• Device Name: CORAIL AMT HIP PROSTHESIS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Feb 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• 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. 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 non-porous Corail AMT Hip Stem is indicated for cementless use only.

Device Story

Corail AMT Hip Prosthesis is a tapered femoral hip stem designed for total hip arthroplasty. Manufactured from F-136 titanium (Ti-6Al-4V) with a hydroxyapatite (HA) coating. Available in multiple configurations: collarless/collared, standard offset, lateralized high offset, and Coxa vara lateralized offset. Implanted by orthopedic surgeons to replace damaged hip joint articulation; aims to increase patient mobility and reduce pain. Device relies on cementless fixation into sound bone. No software or electronic components.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use comparisons to predicate devices.

Technological Characteristics

Material: F-136 titanium (Ti-6Al-4V) with hydroxyapatite (HA) coating. Design: Tapered femoral stem, available in collared/collarless and various offsets. Fixation: Cementless. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head/neck, failed previous hip surgery, or ankylosis. Requires sufficient sound bone for component seating. For cementless use only.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• HA Coating (K953111)
• DePuy Corail Hip stem
• DePuy Titan (K001991)

Submission Summary (Full Text)

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# FEB 1 1 2005

# K042992

# 510(k) Summary

### Name of Sponsor:

510(k) Contact:

Trade Name:

Common Name:

Device Classification And Product Code:

Substantially Equivalent Device:

Device Descriptions:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Est. Reg. No. 1818910

Nancy S. Friddle Senior Regulatory Associate Phone: [phone] FAX: [phone]

### Corail AMTTM Hip Prosthesis

Total Hip Prosthesis

### Class II

LZO; 21 CFR 888.3353; Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

### Class III

KWA; 21 CFR 888.3330; Hip joint metal/metal semi-constrained, with an uncemented acctabular component, prosthesis

HA Coating K953111 DePuy Corail® Hip stem DePuy Titan™ K001991 (Marketed by name Summit™)

The Corail AMT Hip is a tapered stem available both collarless and collared. This hip stem is manufactured from F-136 titanium (Ti-6Al-4V) and has a layer of hydroxyapatite (HA) coating applied. The Corail AMT Hip is available in standard offset, lateralized high offset and a Coxa vara lateralized offset. The standard offset

# 00000006

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### 510(k) Summary (continued)

stems, collared and collarless, are available in 11 sizes (Size 8 to Size 20). The lateralized high offset and the lateralized Coxa vara high offset are available in 8 sizes (Size 9 to Size 16).

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:

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

The non-porous Corail AMT Hip Stem is indicated for cementless use only.

The Corail AMT Hip Prosthesis has the same intended use, is made from the same material and has a similar design as the predicate devices and is therefore substantially equivalent.

No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems.

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Intended use:

#### Indications for use:

Substantial equivalence:

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Public Health Service

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FEB 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nancy S. Friddle Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K042992

Trade/Device Name: Corail AMTTM Hip Prosthesis Regulation Number: 21 CFR 888.3330 and 21 CFR 888.3353 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis and Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Regulatory Class: III Product Code: KWA, LZO, LWJ, and MEH Dated: December 30, 2004 Received: January 3, 2005

Dear Ms. Friddle:

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.

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# Page 2 - Ms. Nancy S. Friddle

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 240-276-0120. 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/industry/support/index.html.

Sincerely vours.

Mark McMillan

Celia 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): _ KO42992 Corail AMTTM Hip Prosthesis Device Name:

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 ostcoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- 2. Avascular necrosis of the femoral head.
- 3. Acute traumatic fracture of the femoral hoad or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. న్న

The non-porous Corail AMT Hip Stem is indicated for cementless use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millison

Division of General, Restorative, and Neurological Devices

KC42992

510(k) Number-

0000008