The GLADIATOR® Plasma Classic 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:

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

GLADIATOR® Plasma Classic Hip Stems are intended for use during uncemented hip arthroplasty.

Device Description

The GLADIATOR® Plasma Classic Hip Stem is a straight uncemented stem, and features a rectangular cross-section, proximally a trapezoidal section manufactured from base material of Titanium alloy (Ti6Al4V - ASTM F620, equivalent to ISO 5832-3). The profile tapers vertically both in frontal and lateral view, to achieve fixation stability in three planes. The stem possesses a 0.5mm thick titanium plasma spray coating on the proximal third of the stem surface, conforming to ASTM F1580. The stem length ranges from 125 mm in length, is available in 10 sizes (1-10), and features 0.5mm thick titanium plasma spray on the proximal third of the stem surface. The stem is available in standard and extended neck offsets.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GLADIATOR® Plasma Classic Hip Stem. This submission aims to demonstrate substantial equivalence to existing predicate devices, not to prove the device meets specific acceptance criteria through a clinical study in the way a new drug or high-risk medical device might.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Nonclinical Testing:
Distal and Proximal Fatigue Evaluation (per ISO 7206-4, -6 and -8)	The GLADIATOR® Plasma Classic Hip Stem "has been tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8." (Implies successful completion of these tests to demonstrate mechanical durability and safety comparable to predicate devices).
Range of Motion Evaluation (per ISO 21535)	The range of motion "was evaluated for GLADIATOR® Plasma Classic Hip Stem according to ISO 21535 (2007)." (Implies the range of motion is within acceptable limits, comparable to predicate devices and suitable for intended use).
Substantial Equivalence (General Criteria for 510(k) pathway):
Identical Indications for Use to Predicate Devices	"The indications for use of the GLADIATOR® Plasma Classic Hip Stem are identical to the previously cleared predicate devices." (This is a statement of claim, not a performance metric per se, but a key acceptance criterion for 510(k)).
Substantially Equivalent Design Features to Predicate Devices	"The design features of the subject device are substantially equivalent to the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices." (Again, a statement of claim for 510(k); the nonclinical tests would support this claim regarding performance).
Identical Materials to Predicate Devices	"The materials used for the GLADIATOR® Plasma Classic Hip Stem are identical to the materials used for the predicate devices." (A direct statement comparing materials for substantial equivalence).
Safety and Effectiveness Adequately Supported by Substantial Equivalence Information, Materials Information, and Analysis Data	"The safety and effectiveness of the GLADIATOR® Plasma Classic Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." (This is the ultimate conclusion, asserting that the provided nonclinical data and comparison to predicates are sufficient for regulatory approval via 510(k)). This is an overall acceptance criterion for the submission itself.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify a "test set" in the context of clinical data for the new device. The testing mentioned in the nonclinical section (fatigue and range of motion) would typically involve a small number of physical samples of the device components, rather than patient data. The document does not provide the number of samples used for these nonclinical tests.
Data Provenance: The data provided is purely nonclinical (mechanical testing). Therefore, there is no country of origin for patient data and it is not retrospective or prospective clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This is not a clinical study involving diagnosis or outcome assessment where expert consensus on "ground truth" would be established. The "ground truth" for the nonclinical tests would be the predetermined international standards (ISO 7206, ISO 21535) and the results of the physical tests against these standards.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" in the clinical sense requiring an adjudication method. The nonclinical tests follow established international standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not provided for the class III hip stem." This indicates that no human factors or reader performance studies were conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical hip stem, not an algorithm or AI product.

7. The Type of Ground Truth Used:

For the nonclinical tests, the "ground truth" is the compliance with established international standards (ISO 7206 series for fatigue and ISO 21535 for range of motion). These standards define acceptable performance parameters for hip joint prostheses.

8. The Sample Size for the Training Set:

Not applicable. There is no training set in the context of a machine learning model or clinical trial for this device. The "training" for this type of device involves engineering design, material selection, and manufacturing processes guided by established engineering principles and prior knowledge from predicate devices.

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

Not applicable. As there's no training set for a data-driven model, there's no ground truth to establish for it. The underlying "ground truth" for the device's design and manufacturing is the body of medical engineering knowledge, regulatory requirements, and the successful performance history of its predicate devices.

Summary

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K 110399 (pg. 1 of 3)

WRIGHT TRADITIONAL 510(k) SUMMARY Gladiator® Plasma Classic Hip Stem

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 Anterior Approach Hip Surgery Instruments.

(a)(1) Submitted By Wright Medical Technology, Inc. Submitter's Name: 5677 Airline Rd Arlington, TN 38002 Phone: (901) 867-4350 Fax No: (901) 867-4190 Date: February 9, 2011 Matt Paul Contact Person: Manager, Regulatory Affairs (a)(2) Device Name Proprietary Name: GLADIATOR® Plasma Classic Hip Stem. Hip Joint Common Name: Classification Name and Reference: Class III - Hip joint metal/metal semiconstrained, with an uncemented acetabular component, prosthesis (21 CFR 888.3330 -Product Code KWA). Class III - Hip joint metal/metal semicemented acetabular constrained, with a component, prosthesis (21CFR 888.3320 -Product Code: JDL). Class II - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21CFR 888.3353 -Product Code: LZO). KWA, JDL, LZO. Orthopedics/87. Subject Product Code and Panel Code: (a)(3) Predicate Device Predicate Proprietary Name: STEM Hip Replacement System - K021346. PRO-FEMUR Hip System - K012091. Metal TRANSCEND Articulation System -K004043. PROFEMUR TL Hip Stem - K060358 Class III - Hip joint metal/ceramic/polymer Predicate Classification and Number: semi-constrained cemented or nonporous uncemented prosthesis (21CFR 888.3353 -

Product Code: LZO).

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K110399 (pg. 2 of 3)

WRIGHT TRADITIONAL 510(k) SUMMARY Gladiator® Plasma Classic Hip Stem

Class III - Hip joint metal/metal semiconstrained, with a cemented acetabular component prosthesis. (21CFR 888.3320 Product Code: JDL).

Class III Hip joint metal/metal . semiconstrained, with an uncemented acetabular component prosthesis. (21CFR 888.3330 -Product Code: KWA).

(a)(4) Device Description

(a)(5) Intended Use

The GLADIATOR® Plasma Classic 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;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
1. correction of functional deformity; and,
revision procedures where other treatments or devices have failed 4.

GLADIATOR® Plasma Classic Hip Stems are intended for use during uncemented hip arthroplasty.

(a)(6) Technological Characteristics of the Device

The GLADIATOR® Plasma Classic Hip Stem has the same technological characteristics as the predicate device. GLADIATOR® Plasma Classic Hip Stem is a straight uncemented hip stem with a monolithic design, possessing a fixed neck. It features 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® Plasma Classic Hip Stem are identical to the materials used for the predicate devices.

(b)(1) Nonclinical Testing

Brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence:

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K 110399 . (pg. 3 of 3)

WRIGHT TRADITIONAL 510(k) SUMMARY Gladiator® Plasma Classic Hip Stem

The GLADIATOR® Plasma Classic Hip Stem has been tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8.

The range of motion was evaluated for GLADIATOR® Plasma Classic Hip Stem according to ISO 21535 (2007).

(b)(2) Clinical Testing

Brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence:

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

(b)(3) Conclusions

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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 Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002

MAY 1 0 2011

Re: K110399

Trade/Device Name: GLADIATOR® Plasma Classic 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, LZQ Dated: February 9, 2011 Received: February 11, 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.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

AS B-nk

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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K.1.0399

WRIGHT TRADITIONAL 510(k) PREMARKET NOTIFICATION GLADIATOR® Plasma Classic Hip Stem

Image /page/5/Picture/2 description: The image shows the word "WRIGHT." in bold, black letters. Below the word are two stylized, overlapping shapes that resemble wings or chevrons. The shapes are also black and appear to be part of the logo or branding associated with the name "WRIGHT."

Indications for Use

510(k) Number (if known):

GLADIATOR® Plasma Classic Hip Stem Device Name:

The GLADIATOR® Plasma Classic 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;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed

GLADIATOR® Plasma Classic Hip Stems are intended for use during uncemented hip arthroplasty.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	for M. Melkerom
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
	K110399

510(k) Number ebruary 9, 2011

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.