The PMMA Distal Centralizers are intended 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, 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 PMMA Distal Centralizers are single use components, intended for use as part of a cemented total hip arthroplasty.

Device Description

The PROFEMUR® X" Wingless Distal Centralizer and PERFECTA® Distal Centralizer are molded PMMA centralizers placed within the femoral canal before the hip stem implant, providing a guide for the implant and allowing the surgeon to easily center the hip stem implant within a uniformly thick cement mantle. The centralizer bears no body weight, since the cured bone cement transfers all loading forces from the stem to the bone. The materials used for the Distal Centralizers are identical to the materials used for the predicate devices (molded PMMA), but unlike the predicate the replacement will not contain any additives.

AI/ML Overview

The provided 510(k) summary does not describe an AI medical device. It pertains to PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer, which are physical medical devices (molded PMMA centralizers for hip stem implants).

Therefore, the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, which are typically associated with AI/ML device evaluations, is not applicable to this document.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

Intended Use and Indications for Use
Technological Characteristics (materials, function)
Nonclinical Testing (mechanical testing, material analysis, cytotoxicity)

Key points from the document regarding the device's assessment:

Acceptance Criteria/Performance: The device is considered to have met acceptance criteria if it is "substantially equivalent" to predicate devices. The document concludes that the PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer are equivalent to predicate devices and are capable of withstanding expected in vivo conditions without failure based on nonclinical testing.
No Clinical Testing: The document explicitly states, "Clinical data was not provided for the centralizers." This means no human subject studies were conducted to assess the device's performance in a clinical setting.
Ground Truth: For a physical device like this, "ground truth" isn't established in the same way as for AI. Instead, it relies on established material science standards and mechanical testing to demonstrate that the device performs as intended and is safe.
Study Type: This is a nonclinical study focused on material characterization and mechanical performance to demonstrate substantial equivalence to legally marketed predicate devices.

Summary of what can be extracted from the document in relation to the prompt's categories (with N/A where not applicable):

Acceptance Criteria and Device Performance (Non-AI Device)

Acceptance Criteria Category	Reported Device Performance/Conclusion
Material Equivalence & Safety	The materials used for the Distal Centralizers are identical to the materials used for the predicate devices (molded PMMA), but the subject device will not contain any additives. Previous predicate testing on material (Kligman sensitization, intracutaneous injection, reverse mutagen assay, chromosomal aberration assay, rodent micronucleus assay, and a 4-week bone implantation assay) is deemed applicable. Subject material analysis (HPLC for residual monomer, GPC for molecular weight, differential scanning calorimetry, FTIR, NMR, GC-MS, and cytotoxicity) indicates equivalence to predicate devices.
Mechanical Performance	Evaluated via mechanical testing (compressive strength). Conclusion: "capable of withstanding expected in vivo conditions without failure."
Intended Use & Indications for Use Equivalence	The intended use and indications for use are identical to the previously cleared predicate devices.
Design Features & Scientific Technology Equivalence	The design features of the devices are unchanged. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices.
Overall Substantial Equivalence (for 510(k) Clearance)	Based on the information provided (material, design, nonclinical testing), the device is substantially equivalent to the predicate devices.

Study Information (as requested by prompt, but adapted for this non-AI device context)

Sample size used for the test set and the data provenance: Not applicable in the context of an AI device. For this physical device, specific N values for experimental samples in mechanical and material tests are not provided in the summary. The tests are nonclinical, performed in a lab setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material and mechanical properties are evaluated against established ASTM standards and comparable predicate device data, not expert consensus on interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a nonclinical device assessment.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, "ground truth" relates to adherence to material specifications (e.g., ASTM F451), measured mechanical properties (compressive strength), and biochemical analyses (e.g., residual monomer, cytotoxicity) which are compared to predicate devices and recognized safety thresholds.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS NOV 1 0 2011

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 HA Hip Stems.

Submitted By:	Wright Medical Technology, Inc.5677 Airline Rd, Arlington TN, 38002(800) 238-7188
Date:	September 30, 2011
Contact Person:	Matt PaulProject Regulatory Affairs Specialist
Proprietary Name:	PROFEMUR® X™ Wingless Distal CentralizerPERFECTA® Distal Centralizer
Common Name:	Centralizer
Classification Name and Reference:	21 CFR 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabularcomponent prosthesis Class
Subject Product Code and Panel Code:	Orthopedics/87/KWA, JDL, LZO, JDI
Predicate Devices Name and Number:	PROFEMUR® X™ (PROFEMUR XTR)NEXUS™ Femoral Hip Stem
	510(k): K052915, K911052
Predicate Classification and Number:	Orthopedics/87/ KWA, 888.3330

Device Information

A. Device Description

The subject material for the PROFEMUR® X" Wingless Distal Centralizer and PERFECTA® Distal Centralizer was evaluated via mechanical testing (compressive strength), residual monomer analysis (HPLC), molecular weight analysis (GPC), and cytotoxicity. A review of these results indicates that

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the PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer are equivalent to predicate devices and are capable of withstanding expected in vivo conditions without failure.

B. Intended Use

Wright Distal Centralizers are intended for use in cemented 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

Wright Distal Centralizers are indicated for cemented hip arthroplasty.

C. Technological Characteristics of the Device

The PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer have the same technological characteristics as the predicate devices. The PMMA Distal Centralizers are placed on the distal end of the hip stem implant during its final insertion into the bone, providing a guide for the implant and allowing the surgeon to easily center the hip stem implant within the femoral canal, and thereby allow a uniformly thick cement mantle. The centralizer bears no body weight, since the cured bone cement transfers all loading forces from the stem to the bone. The material used for the Distal Centralizers identically conforms to ASTM F451 as does the material used for the predicate devices (molded PMMA), but unlike the predicate the replacement will not contain any additives.

D. Nonclinical Testing

The PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer have been tested by mechanical testing (compressive strength), residual monomer analysis (HPLC), molecular weight analysis (GPC), differential scanning calorimetry, FTIR, NMR, GC-MS, and cytotoxicity

E. Clinical Testing

Clinical data was not provided for the centralizers.

F. Conclusions

The indications for use of the PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer are identical to the previously cleared predicate devices. The design features of the devices are unchanged. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer 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

NOV 1 0 2011

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

Re: K113019

Trade/Device Name: Profemur X™ Wingless Distal Centralizers Perfecta Distal Centralizers

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, JDI

Dated: September 30, 2011

Received: October 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. 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/Resourcesfor You/Industry/default.htm_

Sincerely yours,

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

Enclosure

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Kf13019

Indications for Use

Device Name: PROFEMUR® X™ Wingless Distal Centralizer PERFECTA® Distal Centralizer

Indications For Use:

The PMMA Distal Centralizers are intended 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;
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

The PMMA Distal Centralizers are single use components, intended for use as part of a cemented 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)

Michell Wills for MXM

Page 1 of 1

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

510(k) Number K113019

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.