The PROFEMUR® RENAISSANCE® 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® RENAISSANCE® 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 PROFEMUR® RENAISSANCE® Classic Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® RENAISSANCE® Classic Stems offer both reduced flare stems (7 sizes, 10-16), and standard flare stems (9 sizes, 10 - 18) and are coated with titanium plasma spray conforming to ASTM F1580. The subject device offers two neck offset options, Standard (neutral) and Extended (varus), as well as two proximal flare options, Standard and Reduced. The stem geometry, neck length, and neck offset are designed to create options identical to those available with the predicate modular device. The subject devices feature one minor additional change in that they have an impaction slot that is oriented 90 degrees from the impaction feature of the predicate device.

AI/ML Overview

This document describes a 510(k) submission for the PROFEMUR® RENAISSANCE® Classic Stems. The provided text is a summary for a medical device and does not pertain to an AI device or a study involving human readers or AI assistance. Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided information, focusing on the available details from a medical device submission rather than an AI study:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a medical implant (femoral hip stem), and its performance is evaluated through mechanical testing, not through metrics like sensitivity, specificity, or AUC typically used for AI diagnostics.

Acceptance Criteria (Test Standard)	Reported Device Performance Observations
ISO 7206-4 (Proximal Fatigue Test)	Satisfied the acceptance criteria.
ISO 7206-6 (Distal Fatigue Test)	Satisfied the acceptance criteria.
ISO 7206-8 (Fatigue Test)	Satisfied the acceptance criteria.
ISO 21535 (Range of Motion)	Satisfied the acceptance criteria.
Titanium Plasma Spray Coating	Applied according to WMT specification and identical to predicate device.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in terms of number of devices tested, but the tests were mechanical fatigue and range of motion tests on the physical device. This is not a "test set" in the context of AI or clinical studies with patient data.
Data Provenance: The data comes from nonclinical laboratory testing of the device itself (mechanical tests). There is no patient data or geographical provenance described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for mechanical tests is established by meeting predefined engineering specifications and international standards (e.g., ISO). There are no "experts" establishing ground truth in the sense of medical diagnoses or image interpretations.

4. Adjudication method for the test set

Not applicable. This concept pertains to methods for resolving discrepancies in expert opinions, which isn't relevant for mechanical testing.

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

Not applicable. This is not an AI device, and no MRMC study was conducted.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

For mechanical testing, the "ground truth" is defined by compliance with established international standards (ISO 7206-4, 6, 8, and 21535) and internal company specifications for material properties and design.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

Summary of the Study:

The study conducted was a series of nonclinical mechanical tests designed to demonstrate the safety and effectiveness of the PROFEMUR® RENAISSANCE® Classic Stems. These tests were performed on the device itself and were in accordance with recognized international standards for orthopedic implants (ISO 7206 and ISO 21535). The key finding was that the device satisfied the acceptance criteria for all specified tests, including proximal and distal fatigue and range of motion. The titanium plasma spray coating was also confirmed to be identical to that of the predicate device and applied according to specifications. No clinical data was provided. The submission states that the device's substantial equivalence is supported by the nonclinical testing data, materials information, and design features being similar to predicate devices.

Summary

{0}------------------------------------------------

K130984 (pg 1/3)

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

Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a graphic of two angled lines that appear to be overlapping. The text and graphic are black against a white background.

510(k) Summary

MAY 2 4 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 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® RENAISSANCE® Classic Stems.

(a)(1) Submitted By:

Wright Medical Technology, Inc. 5677 Airline Rd Arlington, TN 38002 (901) 867-4146

Date:

Contact Person:

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

Common Name:

Classification Name and Reference:

April 03, 2013

Yuan Li. PhD Regulatory Affairs Specialist II ·

PROFEMUR® RENAISSANCE® Classic Stems

Femoral Hip Stem

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

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

Subject Product Code and Panel Code:

(a)(3) Predicate Devices:

Orthopedics/87/JDI/LZO

PROFEMUR® RENAISSANCE® Hip Stem, K051995

{1}------------------------------------------------

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

(a)(4) Device Description

The purpose of this submission is to add a monolithic femoral neck option to the PROFEMUR® RENAISSANCE® Hip System. The PROFEMUR® RENAISSANCE® Classic Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® RENAISSANCE® Classic Stems offer both reduced flare stems (7 sizes, 10-16), and standard flare stems (9 sizes, 10 - 18) and are coated with titanium plasma spray conforming to ASTM F1580, provided by plasma vendors cleared in K123688. The subject device offers two neck offset options, Standard (neutral) and Extended (varus), which are identical to the predicate stems used with modular necks cleared in K100866 and K091423; as well as two proximal flare options, Standard and Reduced. The stem geometry, neck length, and neck offset are designed to create options identical to those available with the predicate modular device.

The subject devices feature one minor additional change in that they have an impaction slot that is oriented 90 degrees from the impaction feature of the predicate device. This is viewed a minor design change, as the rounded slot is not a worse case compared to the predicate design. This modification to the impaction slot was cleared in K123434 and K123688 with similar devices. In addition, these modifications were evaluated by proximal and distal fatigue testing. These modifications do not affect the intended use or alter the fundamental technology of the device.

Instruments used with the system are identical to ones for the predicate system, except for the stem impactor which was reviewed in K123434 and K123688. The subject devices may also be implanted with instruments for alternative surgical approaches, as cleared in K121221 and K122382. Wright has previously provided validation for the cleaning/sterilization of instruments in previous reviews (K122218).

(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® RENAISSANCE® 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.

The indications for use can be also found in the package insert previously cleared in

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

Tab 007: Page 2 of 3

{2}------------------------------------------------

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

Image /page/2/Picture/1 description: The image shows the word "WRIGHT." in large, bold, sans-serif font. Above the word "WRIGHT." is the text "K130984 (pg 3/3)". Below the word "WRIGHT." is a graphic of two overlapping shapes.

K123434 and K123688.

(a)(6) Technological Characteristics of the Device

The indications for use of the PROFEMUR® RENAISSANCE® Classic Stems are identical to those for the predicate device (K051995). The subject devices are made from an identical titanium alloy (ASTM F620) and possess an identical titanium plasma spray coating (ASTM 1580) as the predicate device. The PROFEMUR® RENAISSANCE® Classic Stems are designed to provide identical range of sizes, neck lengths, and neck offsets as those provided by the modular predicate with the exception of featuring a monolithic neck design and a slightly modified impaction slot.

(b)(1) Nonclinical Testing

The PROFEMUR® RENAISSANCE® Classic Stems were evaluated by 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 (K051995).

(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® RENAISSANCE® Classic Stems are identical to those of the predicate device. 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® RENAISSANCE® 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 901.867.9971 phone Wright Medical Technology, Inc. 5677 Airline Road www.wmt.com

Tab 007: Page 3 of 3

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

May 24, 2013

Wright Medical Technology, Incorporated % Dr. Yuan Li Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K130984

Trade/Device Name: PROFEMUR® RENAISSANCE® 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: April 25, 2013 Received: April 26, 2013

Dear Dr. Li:

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

{4}------------------------------------------------

Page 2 - Dr. Yuan Li

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin I. Keith

For

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

Enclosure

{5}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K130984 (pg 1/1)

Device Name: PROFEMUR® RENAISSANCE® 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® RENAISSANCE® 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)

Elizabeth - Brank -S

Division of Orthopedic Devices

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.