PRESERVE HIP STEM

K112080 · Wrightmedicaltechnologyinc · KWA · Dec 28, 2011 · Orthopedic

Device Facts

• Record ID: K112080
• Device Name: PRESERVE HIP STEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: Dec 28, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Preserve Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Device Story

Preserve Hip Stems are short, modular, cementless hip stems designed for total hip arthroplasty. The device couples with modular necks to replace the femoral component of the hip joint. Used by orthopedic surgeons in a clinical/surgical setting, the device provides structural support for the hip joint to reduce pain and improve function. The stem features a triple-tapered design with proximal medial curvature and is manufactured from titanium alloy with a proximal commercially pure titanium plasma spray coating for osseointegration. The device is implanted during surgery; clinical outcomes depend on proper surgical placement and patient recovery. The device benefits patients by restoring joint function and alleviating pain associated with degenerative joint disease or previous surgical failure.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by mechanical bench testing, including fatigue evaluation per ISO 7206-4, -6, and -8.

Technological Characteristics

Straight, uncemented, modular hip stem. Material: Titanium alloy. Surface: Proximal commercially pure titanium plasma spray coating (ASTM F1580). Design: Triple-tapered with proximal medial curvature. Available in 9 sizes (4-12). Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients requiring uncemented total hip arthroplasty for: 1) non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia); 2) inflammatory degenerative joint disease (rheumatoid arthritis); 3) correction of functional deformity; 4) revision procedures where other treatments/devices failed.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• PROFEMUR® Hip System Modular Necks (K100866)
• PROFEMUR® TL Hip Stem (K091423)
• PROFEMUR® Z (STEM) (K060358)
• PRO-FEMUR® Hip System (K021346)
• PRO-FEMUR® Hip System (K012091)

Submission Summary (Full Text)

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#### 510(K) Summary of Safety and Effectiveness

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® Preserve Hip Stems.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Subject Product Code and Panel Code:

Predicate Devices Name and Number:

Predicate Classification and Number:

Wright Medical Technology, Inc. 5677 Airline Rd, Arlington TN, 38002 [phone]

July 14, 2011

Matt Paul Project Regulatory Affairs Specialist

Preserve Hip Stems

Hip Stem

21 CFR 888.3330 Hip joint metal/metal semiconstrained, with an uncemented acetabular component prosthesis Class III

Orthopedics/87/KWA, JDL, LZO

PROFEMUR® Hip System Modular Necks PROFEMUR® TL Hip Stem. PROFEMUR® Z (STEM) PRO-FEMUR® Hip System

510(k): K100866, K091423, K060358, K021346, K012091

Orthopedics/87/ KWA, 888.3330

### DEVICE INFORMATION

#### A. Device Description

The Preserve stems are short modular hip stems that couple with modular necks. Design features of the stems are summarized below:

- . Cementless stem with proximal cpTi plasma spray coating
- Available in 9 sizes (4-12)
- Manufactured from Ti alloy

The Preserve Hip Stems were evaluated via mechanical testing; including fatigue, fretting; and distraction evaluation. A review of these results indicates that the Preserve Hip Stems are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

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K1120500

#### B. Intended Use

The Preserve Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

#### Indications for Use

- 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- 3. correction of functional deformity: and.
- 4. revision procedures where other treatments or devices have failed

#### C. Technological Characteristic of the Device

The Preserve Hip Stem has the same technological characteristics as the predicate devices. Preserve Hip Stems are straight uncemented hip stems with a modular design. They feature both a triple tapered design and a proximal medial curvature. The proximal portion is coated with a commercially pure titanium plasma spray (conforming to ASTM F1580) that decreases distally in thickness. The materials used for the Preserve® Hip Stems are identical to the materials used for the predicate devices.

#### D. Nonclinical Testing

The Preserve Hip Stems have been tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8.

#### E. Clinical Testing

Clinical data was not provided for the class III hip stem.

#### F. Conclusions

The indications for use of the Preserve Hip Stems are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the Preserve Hip Stem is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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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 stylized depiction of an eagle or bird with three wing-like shapes, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the bird symbol.

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

Wright Medical Technology, Inc. % Mr. Matt Paul 5677 Airline Rd Arlington TN, 38002

DEC 2 8 2011

Re: K112080

Trade/Device Name: Preserve Hip Stems 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, JDL, LZO Dated: December 22, 2011 Received: December 23, 2011

Dear Mr. Matt Paul:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Matt Paul

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.

Sincerely yours.

Sincerely yours,

Mark N Mulkerso

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

Enclosure

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# KII 2080

## Indications for Use

510(k) Number (if known):

Device Name: PRESERVE Hip Stems

Indications For Use:

- 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed.

The Preserve hip stem is intended for cementless hip arthroplasty.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

ulu l'hosse

510(k) Number K112080

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