degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle; .
post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
moderate valgus, varus or flexion deformities; .
treatment of fractures that are unmanageable using other techniques. .

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications

Device Description

The Exprt Revision Knee (ERK) is a tri-compartmental posterior stabilized knee for cemented applications. The system is comprised of three primary components: Femur, Tibial Insert, and Tibial Baseplate. The system is intended to treat patients who are candidates for revision total knee arthroplasty or difficult primary arthroplasty where bone loss may be substantial and the collateral ligaments may be compromised. The design of the knee system is a total condylar design, increasing sagittal conformity and stability. The post and cam of the posterior stabilized design are crucial to inducing femoral rollback and providing resistance to tibial subluxation, substituting the function of the absent PCL. The tibial post, in combination with the femoral cam, provides for greater patient flexion by forcing the femur posteriorly on the tibia.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the "Exprt Revision Knee" device, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as acceptance criteria in terms of specific thresholds for the revision knee device itself. The primary criterion for FDA clearance in this document is demonstrating substantial equivalence to predicate devices.	Mechanical testing demonstrated substantial equivalence to predicate devices in the following aspects: - Static contact area/contact stress testing - Static testing in anterior-posterior draw - Static testing in rotary laxity - Patella subluxation evaluation

Note: The document does not provide specific numerical acceptance criteria or performance metrics (e.g., minimum load bearing capacity, maximum wear rate) for the device. Instead, the focus is on comparability to existing, cleared devices.

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

No test set was used for clinical evaluation. The document explicitly states "Clinical Testing: None provided." The evaluation of the device for substantial equivalence relied solely on non-clinical (mechanical) testing.

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

Not applicable, as no clinical testing with a test set involving human data was performed.

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing with a test set involving human data was performed.

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 device is a revision knee implant, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is a physical knee implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical mechanical testing, the "ground truth" or reference for evaluating substantial equivalence was the performance of predicate devices. The specific types of measurements (e.g., force, displacement, stress) during the mechanical tests served as the data points compared against the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical knee implant, not a machine learning algorithm that requires a training set.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "Exprt Revision Knee" device's acceptance was based on non-clinical mechanical testing demonstrating its substantial equivalence to legally marketed predicate devices.

Study Design: The study involved a series of mechanical tests designed to evaluate the physical performance and characteristics of the Exprt Revision Knee.
Tests Performed:
- Static contact area/contact stress testing
- Static testing in anterior-posterior draw
- Static testing in rotary laxity
- Patella subluxation evaluation
Acceptance Criteria/Outcome: The device was deemed to have met the acceptance criteria because "All testing has determined that the device is substantially equivalent to the predicate devices." The specific quantitative metrics and thresholds for this equivalence are not detailed in the summary but were presumably part of the full 510(k) submission.
Absence of Clinical Data: The submission explicitly states "Clinical Testing: None provided," indicating that FDA clearance was granted based solely on the non-clinical mechanical testing and comparison to existing predicate devices.

Summary

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

JUL 1 1 2014

510(k) Summarv

Date: April 4, 2014

Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djoglobal.com

Comments of Children Comments of Children" " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "and and and the later in the later in the first of the first of the first and a program andToduc-става радации седание продавание с мести представления представления при в пристемента се велические по седельности се подать по-www.backedd.if/forelous/relife/diff/in asserves and the many as a cases an a cases	and a seals nearches child a fine a contra a contra a contra a contra a contra contra a contra contra a contra contra a contra a contra control and contra contra contra a con- 10-Citico-	ANTIQUE AND ALL AND AL AND LAL A CL A ALL L LE CLAND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AMan All Maller Annual And Career Partigen Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company CompMANAGERALE SECURES SECURES FOR CART L------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Carlos C112Auto V	000	A CONSULTION CONSULTION CONSULTION CONTRACTOR COLLECTION OFல்பு

Product Code	Regulation and Classification Name
JWH	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesisper 21 CFR 888.3560
OIY	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesisper 21 CFR 888.3560

Description:

Indications for Use:

Joint replacement is indicated for patients suffering from disability due to:

degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle:
post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, ♥ dysfunction or prior patellectorny;
moderate valgus, varus or flexion deformities:
treatment of fractures that are unmanageable using other techniques. .

The patient's joint must be anatomically and structurally suited to receive the selected implant(s). This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications

Predicate Devices:

DJO Surgical Foundation PS Knee System - K933539 DJO Surgical Movation Knee System -- K100900, K121727 DJO Surgical e+ FMP Acetabular Liner (Accessory Sterilization) -- K130365

Page 1 of 2

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

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same material, indications, surgical implantation technique, and intended use. The same technological characteristics include: same size offerings, same posterior stabilization, same tibial snap lock feature, and same femoral component box width. Differences to the predicate include tibial baseplate dimensions, femoral component dimensions, tibial insert post height, and length of the stem extensions.

Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing included static contact area/contact stress testing, static testing in anterior-posterior draw, static testing in rotary laxity, and patella subluxation evaluation. All testing has determined that the device is substantially equivalent to the predicate devices.

Clinical Testing: None provided.

Page 2 of 2

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus, with flowing lines suggesting movement or connection.

Public Health Service

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

July 11, 2014

Encore Medical, L.P. Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758

Re: K140830 Trade/Device Name: Exprt™ Revision Knee Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: June 5, 2014 Received: June 6, 2014

Dear Ms. Hutto:

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

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

Page 2 - Ms. Teffany Hutto

forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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/ReportalProblem/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 Industry and Consumer Education 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,

Lori A. Wiqqins

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

Enclosure

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

K140830

K140830 510(k) Number (if known):

Device Name: Exprt Revision Knee

Indications for Use:

Exprt™ Revision Knee Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle; .
post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
moderate valgus, varus or flexion deformities; .
treatment of fractures that are unmanageable using other techniques. .

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications

Prescription Use ਮ (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)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Page 1 of 1

000309

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.