DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS

K070554 · DePuy Orthopaedics, Inc. · LZO · Sep 11, 2007 · Orthopedic

Device Facts

• Record ID: K070554
• Device Name: DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Sep 11, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Corail AMT Hip Prosthesis is intended for use in total hip arthroplasty and is intended for press fit (uncemented) 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

Collarless, hydroxyapatite-coated titanium alloy femoral stem; used in total hip arthroplasty; press-fit (uncemented) application. Modification of previously cleared Corail AMT stems featuring shorter stem length, shorter neck length, and smaller cross-section. Implanted by orthopedic surgeons in clinical settings to replace damaged hip joint articulation; aims to increase patient mobility and reduce pain. Contraindicated for patients > 84 lbs.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence supported by fatigue testing results.

Technological Characteristics

Hydroxyapatite-coated titanium alloy femoral stem; collarless design; cementless/press-fit fixation. Dimensions modified (shorter stem/neck, smaller cross-section) compared to predicate.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to osteoarthritis, traumatic/rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture, failed previous hip surgery, or ankylosis. Requires sufficient sound bone for component seating. Contraindicated in patients weighing > 84 lbs.

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

• DePuy Corail AMT Hip Prosthesis (K042992)
• DePuy S-Rom Femoral Hip Stem, Size 12 x 06 x 115 (K961939)

Submission Summary (Full Text)

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#### SUMMARY OF SAFETY AND EFFECTIVENESS

SEP 1 1 2007

| NAME OF FIRM: | DePuy France S.A.<br>7 Allee Irene Joliot Curie<br>69801 Saint Priest cedex<br>France<br>Establishment Registration Number: 9007981 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Kathy Harris<br>Director, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone] |
| TRADE NAME: | DePuy Corail AMT™ Hip Prosthesis |
| COMMON NAME: | Hip Stem |
| CLASSIFICATION: | 21 CFR 888.3330: Hip joint metal / metal semi-constrained<br>prosthesis, with an uncemented acetabular component; Class III<br>21 CFR 888.3353: Hip joint metal / ceramic / polymer semi-<br>constrained cemented or nonporous uncemented prosthesis; Class III |

### DEVICE PRODUCT CODES: LZO, MEH, KWA

| SUBSTANTIALLY | |
|---------------------|--------------------------------------------------|
| EQUIVALENT DEVICES: | DePuy Corail AMT Hip Prosthesis (K042992) |
| | DePuy S-Rom Femoral Hip Stem, Size 12 x 06 x 115 |
| | (K961939) |

#### DEVICE DESCRIPTION:

The Corail AMT Hip Prosthesis is a collarless, hydroxyapatite coated titanium alloy femoral stem. The Corail AMT Hip Prosthesis is similar to the previously cleared Corail AMT Hip Prostheses but has a shorter stem length, shorter neck length and smaller cross-section. The Corail AMT Hip Prostheses is contraindicated in patients weighing more than 84 lbs.

#### INDICATIONS FOR USE:

The Corail AMT Hip Prosthesis is intended for use in total hip arthroplasty and is intended for press fit (uncemented) 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:

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- 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.

## BASIS FOR SUBSTANTIAL EQUIVALENCE:

The Corail AMT Hip Prosthesis is a modification of the Corail AMT Hip Prostheses that were cleared in K042992. Based on similarities in indications, intended use, design, materials, method of manufacture and the results of fatigue testing, DePuy believes that the Corail AMT Hip Prosthesis is substantially equivalent to the previously cleared Corail AMT Hip Prostheses.

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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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 2007

DePuy Orthopaedics, Inc. % Ms. Kathy Harris Director, Regulatory Affairs P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K070554

Trade/Device Name: Corail AMT Hip Prosthesis Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, LZO, MEH Dated: August 13, 2007 Received: August 16, 2007

Dear Ms. Harris:

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 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

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Page 2 - Ms. Kathy Harris

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Barbara Mehm

Mark N. Melkerson 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 Statement

510(k) Number (if known): ____K070554

# Device Name: DePuy Corail AMT Hip Prosthesis

The Corail AMT Hip Prosthesis is intended for use in total hip arthroplasty and is intended for press fit (uncemented) 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oubou Buelund fompon
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

**Neurological Devices**

51000 V. K070554

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