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:

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;
correction of functional deformity; and,
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.

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
Manufactured from Ti alloy
Cemented
Available in 5 sizes
Manufactured from CoCr alloy
Distal centralizers available

AI/ML Overview

Acceptance Criteria and Study for PROFEMUR® Gladiator Hip Stems

This section details the acceptance criteria and the study conducted to demonstrate the safety and effectiveness of the PROFEMUR® Gladiator Hip Stems.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Strength	Ability to withstand expected in vivo loading without failure, as evaluated through fatigue, fretting, and distraction testing.	"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.""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." (Implies meeting the standards set by these ISO specifications, which are designed to ensure mechanical integrity for hip implants.)
Material Compatibility	Use of materials identical to those used in predicate devices with established safety and performance records.	"The materials used for the GLADIATOR® Hip Stems are identical to the materials used for the predicate devices."
Technological Equivalence	The fundamental scientific technology and design features (e.g., modular design, cross-section, tapered profile) are substantially equivalent to predicate devices.	"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 fundamental scientific technology of the modified devices has not changed relative to the predicate devices."
Intended Use & Indications	The intended use and indications for use are identical to previously cleared predicate devices.	"The indications for use of the Gladiator Hip Stems are identical to the previously cleared predicate devices."

2. Sample Size and Data Provenance for the Test Set

Sample Size: Not applicable. This submission relies on non-clinical (mechanical) testing and comparison to predicate devices, not a clinical test set with human subjects.
Data Provenance: The mechanical testing data would be generated from laboratory experiments. The country of origin for this testing is not specified, but it would presumably be conducted by or for Wright Medical Technology, Inc., located in Arlington, TN, USA. The data is prospective in the sense that the tests were conducted specifically for this device submission.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Number of Experts: Not applicable. The ground truth for mechanical testing is established by adherence to international standards (e.g., ISO 7206 series) and engineering principles, not expert consensus on clinical cases.
Qualifications of Experts: Not applicable in the context of clinical ground truth. However, the testing would be overseen by qualified engineers and scientists specialized in biomechanical testing of orthopedic implants.

4. Adjudication Method (Test Set)

Adjudication Method: Not applicable. No clinical test set requiring adjudication of findings was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No.
Effect size of human reader improvement: Not applicable, as no MRMC study was conducted. This device is an implantable orthopedic device, and its approval relies on mechanical performance and substantial equivalence to predicate devices, not on the interpretation of medical images or data by human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Was a standalone study done? Yes, in the context of mechanical testing. The device's performance was evaluated in isolation through fatigue, fretting, and distraction tests as per ISO standards. This is a "standalone" evaluation of the physical device's mechanical integrity.
Details of the study: The GLADIATOR® Hip Stems underwent "distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8," in addition to fretting and distraction evaluation. The results demonstrated equivalence to predicate devices and the capability to withstand in vivo loading.

7. Type of Ground Truth Used (Test Set)

Type of Ground Truth: The ground truth for this submission is based on adherence to international mechanical testing standards (ISO 7206-4, -6, and -8) and the established safety and effectiveness profile of predicate devices through direct comparison of design features, materials, and mechanical performance. There is no clinical or pathology-based ground truth from a test set of human cases.

8. Sample Size for the Training Set

Sample Size: Not applicable. This device approval is based on a 510(k) submission demonstrating substantial equivalence, primarily through mechanical testing and comparison to existing predicate devices. It does not involve machine learning algorithms or a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable. As there is no training set for a computational model, there is no ground truth to establish for it. The "ground truth" in the broader sense for this submission is derived from the established performance and safety of the predicate devices and the robust mechanical testing standards it adheres to.

Summary

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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.5677 Airline Rd, Arlington TN, 38002(800) 238-7188
Date:	September 30, 2011
Contact Person:	Gregory NealRegulatory 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-constrained, with an uncemented acetabularcomponent prosthesisClass III
Subject Product Code and Panel Code:	Orthopedics/87/KWA, JDL, LPH, LZO, JDI
Predicate Devices Name and Number:	PROFEMUR ® Hip System Modular NecksPROFEMUR ® ZPROFEMUR ® Hip SystemPROFEMUR ® X™ Hip StemPROFEMUR ® TL Hip StemCORAIL ® Hip ProsthesisDYNASTY ® BIOFOAM™ Acetabular System510(k): K100866, K091423, K021346, K012091,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;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and, 3.
1. 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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
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).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.