PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM

K111699 · Wrightmedicaltechnologyinc · KWA · Aug 19, 2011 · Orthopedic

Device Facts

• Record ID: K111699
• Device Name: PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: Aug 19, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is a single use component, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

Device Story

Modular, uncemented distal femoral implant; designed for total hip arthroplasty. Couples with PROFEMUR® CoCr modular necks and ceramic or metal femoral heads. Features titanium plasma spray coating on proximal 1/3 of stem to facilitate bone apposition. Used by orthopedic surgeons in clinical settings. Provides structural support for hip joint; intended to reduce pain and improve function. Single-use device.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by bench testing, including distal and proximal fatigue tests (ISO 7206-4, 6, 8) and evaluation of fretting corrosion and axial disassembly force (ASTM F1875, F2009).

Technological Characteristics

Material: Forged Titanium Alloy (ASTM F620). Coating: Titanium plasma spray (ASTM F1580) on proximal 1/3. Modular design with taper socket. Uncemented fixation. Mechanical device; no software or energy source.

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), correction of functional deformity, or revision procedures where other treatments 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

• STEM Hip Replacement System (K021346)
• PRO-FEMUR Hip System (K012091)
• Metal TRANSCEND Articulation System (JDL)
• Hip joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis (K004043)

Submission Summary (Full Text)

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K111699(pg1/2)

Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the text "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company".

AUG 1 9 2011

## 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 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem.

| (a)(1) Submitted By<br>Submitter's Name: | Wright Medical Technology, Inc.<br>5677 Airline Rd. Arlington, TN 38002<br>800-238-7188 (phone), 901-867-4190 (fax) |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 19, 2011 |
| Contact Person: | Gregory Neal<br>Regulatory Affairs Specialist II |
| (a)(2) Device Name<br>Proprietary Name: | PROFEMUR® Z Titanium Plasma Sprayed Hip<br>Stem |
| Common Name: | Hip Stem |
| Classification Name and Reference: | 21 CFR 888.3320 Hip joint metal/metal semi-<br>constrained, with an uncemented acetabular<br>component, prosthesis Class III |
| Subject Device Product Code and Panel Code: | Orthopedics/87/ JDL, KWA, LPH, LZO |
| (a)(3) Predicate Device<br>Predicate Proprietary Name:<br>Predicate Classification and Number: | STEM Hip Replacement System<br>888.3358 LPH Hip joint metal/polymer/ metal semi-<br>constrained porous-coated uncemented prosthesis<br>Class II (510k-K021346) |
| | PRO-FEMUR Hip System<br>888.3353 LZO Hip joint metal/ceramic/polymer<br>semi-constrained cemented or nonporous uncemented<br>prosthesis Class II (510k-K012091) |
| | Metal TRANSCEND Articulation System<br>888.3320 JDL Hip joint metal/metal semi-<br>constrained, with a cemented acetabular component<br>prosthesis Class III |
| | 888.3330 KWA Hip joint metal/metal semi-<br>constrained, with an uncemented acetabular<br>component prosthesis Class III (510k-K004043) |

## (a)(4) Device Description

The modular PROFEMUR® Z Titanium Plasma Sprayed hip stem is an uncemented distal femoral implant designed to couple with Wright Medical Technology's PROFEMUR® CoCr modular necks. The stem design was developed from the previously marketed PROFEMUR® Z Hip Stem ('STEM' K021346) and features the identical modular neck taper socket and is made of the identical Titanium alloy (ASTM F620) as previous hip stem designs by Wright.

The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem leatures the identical substrate cross-sectional geometry

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as the PROFEMUR® Z Hip Stem (K0213146) with the addition of titanium plasma spray coating conforming to ASTM F1580 applied according to WMT specifications which covers the proximal 1/3 of the stem.

### (a)(5) Intended Use of the Device

Intended Use

The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is intended for use in 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;
- 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 PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is a single use component, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

#### (a)(6) Technological Characteristics of the Device

The indications for use for the PROFEMUR® Z Titanium Plasma Sprayed are identical to those for all existing Wright PROFEMUR® hip stems. The indications are applied to all PROFEMUR® hip stems and have been cleared in 510(k)s: K041114, K041586, K051995, K052915, K053588, K060358, K080663, K081090, K091423, and K100866.

The PROFEMUR® Z Titanium Plasma Sprayed Stem is identical in design and manufactured from the same forged Titanium Alloy (ASTM F620) as the PROFEMUR® Z Hip Stem ('STEM Hip Replacement System' K021346). The subject device has titanium plasma spray coating on the proximal 1/3of its surface, is offered in the same range of sizes, has the same features, and has the same intended use (non-cemented total hip replacement) as the predicate device. The titanium plasma spray coating to WMT specifications. The titanium plasma sprav coating is identical to the plasma spray coating used on the PRO-FEMUR Hip System (K012091). The surface finish of the non-coated portions of the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is identical to the PROFEMUR® Z Hip Stem ('STEM Hip Replacement System' K021346),

### (b)(1) Nonclinical Testing

The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem conforms to the Guidance for Industry and FDA Staff titled "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" issued April 28, 1994. The titanium plasma spray coating used for the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is verified by tesent within a vendor Master File. The coated stem was evaluated in distal and proximal fatigue tests according to ISO 7206-4, 6, and 8. Fretting corrosion and axial disassembly force of the coated stem were evaluated according to ASTM F1875 and F2009. Titanium Plasma Spray Coating is applied according to WMT specification and is identical to the titanium plasma spray used for the previously cleared PRO-FEMUR Hip System (K012091).

#### (b)(2) Clinical Testing

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

#### (b)(3) Conclusions

The indications for use of the PROFEMUR® Z Titanium Plasma Sprayed 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 subject device has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® Z Titanium Plasma Sprayed is adequately supported by the substantial equivalence information, and analysis data provided within this Premarket Notification.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Wright Medical Technology, Inc. % Mr. Gregory Neal Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

AUG 1 9 2011

Re: K111699

Trade/Device Name: PROFEMUR® Z Titanium Plasma Sprayed 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, JDL, LPH, LZO Dated: July 21, 2011 Received: July 22, 2011

Dear Mr. Neal:

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

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Page - 2 - Mr. Gregory Neal

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 device-related adverse events) (21 CFR 803): vood 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.

Sincerely yours,

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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# Indications for Use

Device Name: PROFEMUR® Z Titanium Plasma Sprayed Hip Stem

Indications For Use:

The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

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

The PROFEMUR® Z Titanium Plasma Sprayed Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111699