The PROFEMUR® Z Classic Stems are indicated 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 PROFEMUR® Z Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

Device Description

The purpose of this submission is to add a monolithic femoral neck option to the PROFEMUR® Z Hip System. The PROFEMUR® Z Classic Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Z Classic Stems are available in 9 sizes (1-9) and are available in two surface finish options: gritblast or titanium plasma spray conforming to ASTM F1580. Each size is available with either a long or short fixed femoral neck and all sizes are available in two neck offset options, Standard (neutral) and Extended (varus). The surface finish options, neck lengths, and neck offset are designed to create options identical to those available with the predicate modular devices.

AI/ML Overview

The provided text describes the PROFEMUR® Z Classic Stems and a special 510(k) submission. It focuses on the comparison of the new device to predicate devices for substantial equivalence, primarily through nonclinical testing.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Proximal fatigue tests in accordance with ISO 7206-4, 6, and 8	Satisfied the acceptance criteria of each.
Distal fatigue tests in accordance with ISO 7206-4, 6, and 8	Satisfied the acceptance criteria of each.
Range of motion evaluated in accordance with ISO 21535	Satisfied the acceptance criteria.
Titanium plasma spray coating applied according to WMT specification	Identical to that used in the predicate device (K111699). (Verified by testing present within a vendor Master File)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Clinical data was not provided for the subject devices."
Therefore, there is no test set of clinical data for human performance, and thus no information on sample size or data provenance in that regard. The "test set" here refers to the physical devices undergoing nonclinical testing. The sample sizes for these physical tests are not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is an orthopedic implant, and the ground truth for its performance is established through engineering and biomechanical testing (nonclinical), not expert interpretation of clinical data in the way medical imaging devices might require.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, the "test set" refers to physical devices undergoing nonclinical testing, not clinical cases requiring expert adjudication.

5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical imaging or diagnostic devices where human readers interpret data, often with or without AI assistance. This document pertains to a hip stem implant, which does not involve human readers interpreting AI output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm or a diagnostic device. The "standalone" performance here refers to the physical device's mechanical integrity and range of motion, which was evaluated through nonclinical testing as described in section (b)(1).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the device's performance is based on:

Engineering specifications and standards: Adherence to ISO 7206-4, 6, and 8 for fatigue tests, and ISO 21535 for range of motion.
Manufacturer specifications: Conformity to Wright Medical Technology (WMT) specifications for the titanium plasma spray coating, and comparison to predicate device material and design characteristics (ASTM F620 for titanium alloy).
Vendor Master File: Verification of the titanium plasma spray coating through testing summarized in a vendor Master File.

8. The sample size for the training set

Not applicable. The document explicitly states "Clinical data was not provided for the subject devices." There is no mention of an AI model or a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI algorithm mentioned in the document.

Summary

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PROFEMUR® Z Classic Stems Special 510(k) 510(k) Summary

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510(k) Summary

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 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® Z Classic Stems.

(a)(1) Submitted By:

Date:

Contact Person:

(a)(2) Proprietary Name of Modified Device:

Common Name:

Classification Name and Reference:

Subject Product Code and Panel Code:

(a)(3) Predicate Devices:

Wright Medical Technology, Inc. 5677 Airline Rd Arlington, TN 38002 (800) 238-7188

November 5, 2012

David Fitch, PhD Clinical Affairs Specialist

· PROFEMUR® Z Classic Stems

Femoral Hip Stem

888.3350 JDI Hip joint metal/polymer semiconstrained cemented prosthesis Class II

888.3353 LZO Hip joint metal/ceramic/polymer, cemented or non-porous, uncemented prosthesis Class II

Orthopedics/87/JDI/LZO

PROFEMUR® Z Plasma-Coated Hip Stem, K111699

STEM Hip Replacement System, K021346

Tab 07: Page 1 of 3

FEB 5 2013

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PROFEMUR® Z Classic Stems Special 510(k)

510(k) Summary

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(a)(4) Device Description

(a)(5) 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.

The PROFEMUR® Z Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

(a)(6) Technological Characteristics of the Device

The indications for use of the PROFEMUR® Z Classic Stems are identical to those for the predicate devices (K111699, K021346). The subject devices are made from an identical titanium alloy (ASTM F620) as the predicate devices. The PROFEMUR® Z Classic Stems are designed to provide identical range of sizes, surface finishes, neck lengths, and neck offsets as those provided by the modular predicates. The subject device design is identical to that of the predicate devices with the exception of featuring a monolithic neck design and a slightly modified impaction slot.

(b)(1) Nonclinical Testing

The PROFEMUR® Z Classic Stems were evaluated in proximal and distal fatigue tests in accordance with ISO 7206-4, 6, and 8 and satisfied the acceptance criteria of each. Range of motion was evaluated in accordance with ISO 21535 and the subject device satisfied the acceptance criteria. The titanium plasma spray coating is applied according to WMT specification and is identical to that used in the predicate device (K111699). The titanium plasma spray coating was verified by testing present within a vendor Master File and summarized within this premarket notification.

Headquarters

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone www.wmt.com

Tab 07: Page 2 of 3

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PROFEMUR® Z Classic Stems Special 510(k) 510(k) Summary

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(b)(2) Clinical Testing

Clinical data was not provided for the subject devices.

(b)(3) Conclusions

The indications for use and fundamental scientific technology of the PROFEMUR® Z Classic Stems are identical to those of the predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The safety and effectiveness of the PROFEMUR® Z Classic Stems is adequately supported by the substantial equivalence information, materials information, and nonclinical testing data provided within this premarket notification.

Headquarters Arlington, TN 38002 Wright Medical Technology, Inc. 5677 Airline Road www.wmt.com

Tab 07: Page 3 of 3

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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

Wright Medical Technology, Incorporated % David Fitch, Ph.D. Clinical Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Letter dated: February 5, 2013

Re: K123434

Trade/Device Name: PROFEMUR®Z Classic Stems 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: January 7, 2013 Received: January 8, 2013

Dear Dr. Fitch:

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 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 - Dr. David Fitch

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,

Mark N. Melkerson

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

Enclosure

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PROFEMUR® Z Classic Stems Special 510(k) Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K123434

Device Name: PROFEMUR® Z Classic Stems

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.

The PROFEMUR® Z Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael C. Owens 2013.02.05 12:11:26 -05'00'

Division of Orthopedic Devices

Headquarters Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone www.wmt.com

Tab 06: Page 1 of 1

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.