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™ Distal Centralizers 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 material used for the Distal Centralizers identically conforms to the same material standard as the predicate devices (molded PMMA), but will use a new material resin. Like the predicate, the replacement resin will contain 2 copolymers, designed to contribute to material properties.

AI/ML Overview

This document describes a 510(k) summary for the PROFEMUR® X™ Distal Centralizers, a medical device used in total hip arthroplasty. The submission claims substantial equivalence to predicate devices based on nonclinical testing.

Here's an analysis of the provided text with respect to acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance in the traditional sense (e.g., statistical thresholds for accuracy, sensitivity, specificity). Instead, the acceptance is based on demonstrating "equivalence" to predicate devices through functional and biocompatibility testing, and chemical analysis.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence in material properties to predicate devices	"The material used for the Distal Centralizers identically conforms to the same material standard as the predicate devices (molded PMMA), but will use a new material resin. Like the predicate, the replacement resin will contain 2 copolymers, designed to contribute to material properties." "The material used for the Distal Centralizers identically conforms to ASTM F451 as does the material used for the predicate devices (molded PMMA)."
Ability to withstand expected in vivo conditions without failure	"The worst case design of the subject material for the PROFEMUR® X™ Centralizers was evaluated via functional testing, chemical analysis and biocompatibility. A review of these that the PROFEMUR® X" Centralizers are equivalent to predicate devices and are capable of withstanding expected in vivo conditions without failure."
Identical indications for use as predicate devices	"The indications for use of the PROFEMUR® X™ Distal Centralizers are identical to the previously cleared predicate devices."
Unchanged design features and processing	"The design features and processing of the devices are unchanged."
Unchanged fundamental scientific technology	"The fundamental scientific technology of the modified devices has not changed relative to the predicate devices."

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "test set" in the context of clinical or performance data from human subjects. The evaluation was based on nonclinical (laboratory) testing. Therefore, sample sizes for functional testing, chemical analysis, and biocompatibility would be relevant here, but they are not provided in the document.
- Data Provenance: The data provenance is from nonclinical testing conducted by Wright Medical Technology, Inc. There is no mention of country of origin for any data, nor if it was retrospective or prospective, as it's not a clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this submission. The ground truth was established through engineering and scientific testing standards (e.g., ASTM F451 for material conformity, biocompatibility testing standards). There is no mention of human experts establishing ground truth for performance in the way experts would for medical image review or diagnostic accuracy.
Adjudication method for the test set:
- This is not applicable. There was no "test set" requiring adjudication by human experts. The evaluation focused on material and functional equivalence demonstrated through nonclinical tests.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical implant (a centralizer for hip surgery), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI" is not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the nonclinical evaluation was based on established engineering and material standards, and the performance characteristics of the predicate devices. For example, conformity to ASTM F451 for PMMA is a form of ground truth for material properties, and the ability to withstand in vivo conditions without failure is a ground truth established through functional testing simulating those conditions.
The sample size for the training set:
- This is not applicable. There was no "training set" as this is not an AI/machine learning device. The material properties and design were likely developed through standard engineering design processes, possibly involving iterative testing and refinement, but not in the context of a "training set" for an algorithm.
How the ground truth for the training set was established:
- This is not applicable as there was no training set for an algorithm.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

APR 1 9 2013

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® X™ Distal Centralizers.

Submitted By:

.
.
.
.

Date:

Contact Person:

5677 Airline Rd, Arlington TN, 38002 (800) 238-7188

Wright Medical Technology, Inc.

January 22, 2013

Matt Paul Regulatory Affairs

Proprietary Name:

Common Name:

Classification Name and Reference:

Subject Product Code and Panel Code:

Predicate Devices Name and Number:

PROFEMUR® X™ Distal Centralizers

Centralizer

21 CFR 888. 3353 LZO Hip joint metal/ceramic/ polymer, cemented or non-porous, uncemented prosthesis Class II

Orthopedics/87/ LZO, JDI

PROFEMUR® X™ (PROFEMUR XTR)

510(k): K052915

Predicate Classification and Number:

Orthopedics/87/ LZO, 888.3353

DEVICE INFORMATION

A. Device Description

The worst case design of the subject material for the PROFEMUR® X™ Centralizers was evaluated via functional testing, chemical analysis and biocompatibility. A review of these that the PROFEMUR® X" Centralizers are equivalent to predicate devices and are capable of withstanding expected in vivo conditions without failure.

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B. Intended Use

Wright 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.

Indications for Use

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.
correction of functional deformity; and, 3.
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™ Distal Centralizers have the same technological characteristics as the predicate devices. The PMMA Distal Centralizers are placed on 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).

D. Nonclinical Testing

The PROFEMUR® X" Distal Centralizers have been tested by functional and biocompatibility testing, and chemical analysis. A review of the results indicates that the PROFEMUR® X™ Centralizers are equivalent to predicate devices and are capable of withstanding expected in vivo conditions without failure.

ن Clinical Testing

Clinical data was not provided for the centralizers.

ﻨﺎ Conclusions

The indications for use of the PROFEMUR® X™ Distal Centralizers are identical to the previously cleared predicate devices. The design features and processing 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™ Distal Centralizers are adequately supported by the substantial equivalence information, materials information, and analysis data summarized within this Premarket Notification.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: April 19, 2013

Wright Medical Technology. Incorporated % Mr. Matt Paul Project Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002

Re: K130167

Trade/Device Name: PROFEMUR® X™ Distal Centralizers Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, JDI Dated: February 28, 2013 Received: March 1, 2013

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. Iisting 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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N.Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K130167

Indications for Use

Device Name: PROFEMUR® X™ Distal Centralizers

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:

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;
ന് 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)

Elizabet កើរ

Division of Orthopedic Devices

Regulation Number and Section

N/A