GLADIATOR HIP STEM

K111910 · Wrightmedicaltechnologyinc · KWA · Oct 14, 2011 · Orthopedic

Device Facts

• Record ID: K111910
• Device Name: GLADIATOR HIP STEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: Oct 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Gladiator 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. The Gladiator cpTi Plasma Sprayed hip stem is intended for cementless hip arthroplasty. The Cemented hip stem is intended for cemented hip arthroplasty.

Device Story

Gladiator Hip Stems are modular hip prostheses designed for total hip arthroplasty. System includes cementless stems (Ti alloy with proximal cpTi plasma spray coating) and cemented stems (CoCr alloy with distal centralizers). Stems feature proximal trapezoidal and distal rectangular cross-sections with vertically tapered profiles for three-plane fixation stability. Devices are implanted by orthopedic surgeons in clinical settings to replace diseased hip joints, aiming to reduce pain and restore function. Stems couple with modular necks. Safety and performance are established through mechanical fatigue, fretting, and distraction testing.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including distal and proximal fatigue evaluation performed in accordance with ISO 7206-4, -6, and -8 standards.

Technological Characteristics

Modular hip stems; cementless (Ti alloy, proximal cpTi plasma spray) and cemented (CoCr alloy) variants. Features proximal trapezoidal and distal rectangular cross-sections; vertically tapered profile for three-plane fixation. Mechanical testing per ISO 7206-4, -6, -8.

Indications for Use

Indicated for skeletally mature patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, or requiring revision procedures after failed prior treatments.

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® Z (K091423)
• PROFEMUR® Hip System (K021346)
• PROFEMUR® X™ Hip Stem (K012091)
• PROFEMUR® TL Hip Stem (K052915)
• CORAIL® Hip Prosthesis (K060358)
• DYNASTY® BIOFOAM™ Acetabular System (K953111, K042992, K082924)

Submission Summary (Full Text)

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## KIII910 (pq1/2)

### OCT 1 4 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, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® Gladiator Hip Stems.

| Submitted By: | Wright Medical Technology, Inc.<br>5677 Airline Rd, Arlington TN, 38002<br>[phone] |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 30, 2011 |
| Contact Person: | Gregory Neal<br>Regulatory Affairs Specialist II |
| Proprietary Name: | Gladiator Hip Stems |
| Common Name: | Hip Stem |
| Classification Name and Reference: | 21 CFR 888.3330 Hip joint metal/metal semi-<br>constrained, with an uncemented acetabular<br>component prosthesis<br>Class III |
| Subject Product Code and Panel Code: | Orthopedics/87/KWA, JDL, LPH, LZO, JDI |
| Predicate Devices Name and Number: | PROFEMUR ^® Hip System Modular Necks<br>PROFEMUR ^® Z<br>PROFEMUR ^® Hip System<br>PROFEMUR ^® X™ Hip Stem<br>PROFEMUR ^® TL Hip Stem<br>CORAIL ^® Hip Prosthesis<br>DYNASTY ^® BIOFOAM™ Acetabular System<br>510(k): K100866, K091423, K021346, K012091,<br>K052915, K060358, K953111, K042992, K082924 |
| Predicate Classification and Number: | Orthopedics/87/ KWA, 888.3330 |

### Device Information

#### A. Device Description

The Gladiator stems are 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 10 sizes r
- i Manufactured from Ti alloy
- . Cemented
- Available in 5 sizes
- . Manufactured from CoCr alloy
- 배 Distal centralizers available

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

#### 8. Intended Use

The Gladiator 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;
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and, 3.
- 4. revision procedures where other treatments or devices have failed

The Gladiator cpTi Plasma Sprayed hip stem is intended for cementless hip arthroplasty. The Cemented hip stem is intended for cemented hip arthroplasty.

#### C. Technological Characteristic of the Device

The GLADIATOR® Hip Stems have the same technological characteristics as the predicate device. GLADIATOR® Hip Stems are straight cemented and uncemented hip stems with a modular design. They feature a proximal trapezoidal cross-section and a distal rectangular cross-section. For fixation stability in three planes, the stem has a vertically tapered profile in the frontal and lateral planes. The materials used for the GLADIATOR® Hip Stems are identical to the materials used for the predicate devices.

#### D. Nonclinical Testing

The GLADIATOR® 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 Gladiator 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 Gladiator Hip Stems are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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

OCT 1 4 2011

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

Re: K111910

Trade/Device Name: Gladiator 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, LPH, LZO, JDI Dated: October 12, 2011 Received: October 13, 2011

Dear Mr. 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

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Page - 2 - Mr. Matt Paul

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin Keith

Sr 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

# 510(k) Number (if known): K1119106pq 1/1)

Device Name: Gladiator Hip Stems

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.
- correction of functional deformity; and, ന്
- revision procedures where other treatments or devices have failed. 4.

The Gladiator cpTi Plasma Sprayed hip stem is intended for cementless hip arthroplasty.

The Gladiator Cemented hip stem is intended for cemented 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)

Richard Owens to MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K111910
510(k) Number