DEPUY RECLAIM REVISION HIP SYSTEM

K102080 · Depuy(Ireland) · LZO · Nov 23, 2010 · Orthopedic

Device Facts

• Record ID: K102080
• Device Name: DEPUY RECLAIM REVISION HIP SYSTEM
• Applicant: Depuy(Ireland)
• Product Code: LZO · Orthopedic
• Decision Date: Nov 23, 2010
• 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.

Device Story

Modular tapered hip stem system for revision hip arthroplasty; used to replace damaged hip joint articulation in patients with sufficient bone stock. Device implanted by orthopedic surgeons in clinical settings. System provides structural support to restore mobility and reduce pain following failed prior hip procedures. Substantial equivalence established via bench testing comparing geometry, design, and fatigue performance to predicate systems.

Clinical Evidence

No clinical testing was required to demonstrate substantial equivalence; evidence is based on non-clinical bench testing.

Technological Characteristics

Modular tapered hip stem system. Materials and geometry designed for cementless revision arthroplasty. Performance validated via neck fatigue testing (ISO 7206-6:1992) and distal fatigue testing (ISO 7206-4:1989).

Indications for Use

Indicated for cementless use in patients requiring treatment for failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

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 Spectrum Modular System (K033893)
• DePuy Solution Hip System (K060581)

Submission Summary (Full Text)

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# KID200000g 1/2)

,

## Section 5: 510 (k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93)

| NAME OF SPONSOR: | DePuy (Ireland)<br>Loughbeg<br>Ringaskiddy<br>Co. Cork<br>Ireland<br>Establishment Registration Number: 9616671 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer<br>Senior Regulatory Affairs Associate<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | July 14, 2010 |
| PROPRIETARY NAME: | DePuy RECLAIM Revision Hip System |
| COMMON NAME: | Hip Stem Prosthesis |
| CLASSIFICATION AND<br>REGULATION: | Class III per 21 CFR 888.3330: Hip joint<br>metal/metal semi-constrained, with an<br>uncemented acetabular component, prosthesis<br>(KWA)<br><br>Class II per 21 CFR 888.3353: Hip joint<br>metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prosthesis<br>(LZO) |
| DEVICE PRODUCT CODE AND<br>DESCRIPTION: | KWA: prosthesis, hip, semi-constrained (metal<br>uncemented acetabular component)<br><br>LZO: prosthesis, hip, semi-constrained,<br>metal/ceramic/polymer, cemented or non-porous,<br>uncemented |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE(S): | DePuy Spectrum Modular System, K033893<br>DePuy Solution Hip System, K060581 |

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#### DEVICE DESCRIPTION:

The ReClaim Revision Hip System is a modular tapered hip stem system that is intended for use in revision hip arthroplasty.

#### INDICATIONS AND INTENDED USE:

#### Indications:

The DePuy RECLAIM Revision Hip System is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

#### 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.

#### Summary of Technologies/Substantial Equivalence:

The substantial equivalence of the subject RECLAIM Revision Hip System is demonstrated by similarities in intended use, indications for use, materials, geometry, design and performance as compared to the predicate devices. The changes presented in this 510(k) do not present new issues of safety or effectiveness.

#### Non-clinical Testing:

RECLAIM neck fatigue testing meets the ISO-7206-6:1992 specification when tested to 10 million cycles at 1200 lbf in air. Distal fatigue testing per ISO 7206-4:1989 demonstrated that the subject device achieved higher maximum loads prior to failure when compared to the predicate Spectrum and Solution devices. This testing, coupled with evaluations of the device design and geometry, demonstrated that the subject devices met the applicable performance requirements and are as safe and effective as the predicates.

#### Clinical Testing:

No clinical testing was required to demonstrate substantial equivalence.

#### Conclusion:

The subject DePuy RECLAIM Revision Hip System is substantially equivalent to the predicate devices identified in this premarket notification.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DePuy (Ireland) % DePuy Orthopaedics, Inc. Ms. Rhonda Myer Senior Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46582

NOV 2 3 2010

Re: K102080

Trade/Device Name: DePuy RECLAIM Revision Hip Stem 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 Dated: November 10, 2010 Received: November 12, 2010

Dear Ms. Myer:

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 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); medical device reporting of medical

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Page 2 - Ms. Rhonda Myer

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

ncerely yours.

Вавае Вжецнр

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Section 4: Indications for Use Statement

510 (k) Number (if known): _K102080(pq 1/1)

Device Name: DePuy RECLAIM Revision Hip System

NOV 2 3 2010

#### Indications for Use:

The DePuy RECLAIM Revision Hip System is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line. Continue on another page if needed.)

Omtu for mxm
(Division Sign-off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102080