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.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia, and Porous Patella which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Revision VVC+, e+™ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:

Absence or loss of both cruciate ligaments
Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon
Bone loss that requires supplemental fixation in the clinical judgment of the surgeon

Device Description

The EMPOWR Revision Knee™ system is intended for use in total knee arthroplasty. The system includes femoral components, tibial components, tibial inserts, cones, stems, stem extenders, and augments. Components are available in various sizes and configurations to accommodate a range of patient anatomies and surgeon preferences.

The purpose of this submission is to obtain clearance for using vaporized hydrogen peroxide (VHP) as a sterilization method for the EMPOWR VVC+, e+ Tibial Insert component. The subject device is identical in design, materials, and intended use to the predicate.

AI/ML Overview

This FDA 510(k) clearance letter pertains to a medical device, the EMPOWR Revision Knee™ system, specifically focusing on the clearance for a new sterilization method (Vaporized Hydrogen Peroxide - VHP) for the EMPOWR Revision VVC+, e+ Tibial Insert component. The document explicitly states that no clinical data or animal studies were submitted for this clearance. Instead, the substantial equivalence to the predicate device is based on non-clinical performance data (verification and validation activities).

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for a clinical or AI-based study cannot be extracted from this document, as it is not relevant to the type of submission described.

The document discusses the following non-clinical performance data:

A table of acceptance criteria and the reported device performance:

This information is not explicitly presented in a table format within the provided document. However, the document states that "Verification and validation activities demonstrate substantial equivalence between the subject and predicate devices." and lists the types of tests conducted. To fully answer this, one would typically need access to the actual verification and validation reports.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Sterilization Efficacy	Validated for VHP
Shelf-Life Stability	Demonstrated stability
Packaging Integrity	Demonstrated integrity
Biocompatibility (Cytotoxicity)	Met biocompatibility requirements
Material Properties	Maintained material characteristics
Wear Resistance	Comparable to predicate (Pin-on-disk)
Fatigue Strength (Lock Detail)	Met strength requirements
Fatigue Strength (Tibial Post)	Met strength requirements

Sample sizes used for the test set and the data provenance:
- Sample sizes: Not specified in the provided text. These would be detailed in the individual test reports for each verification and validation activity.
- Data provenance: Not specified. This would typically come from internal laboratory testing or contract research organizations. The document indicates these are "Verification and validation activities," implying laboratory-based testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth in the traditional sense. The "ground truth" for non-clinical testing refers to established engineering or biological standards.
Adjudication method for the test set:
- Not applicable. Adjudication is typically for clinical or interpretation-based studies. Non-clinical tests follow predefined protocols and acceptance limits.
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. The document explicitly states: "No clinical data submitted." This is not a study involving human readers or AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-based device.
The type of ground truth used:
- For the non-clinical tests listed (Sterilization Validation, Shelf-Life Study, Packaging Testing, Cytotoxicity, Material Characterization, Pin-on-disk Wear, Lock Detail Fatigue, Tibial Post Fatigue), the "ground truth" would be established engineering standards, regulatory requirements, and validated testing methodologies.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device requiring a training set.

In summary, the provided document is a 510(k) clearance letter for a medical device that highlights a change in sterilization method. The substantial equivalence argument is based entirely on non-clinical performance testing, not clinical trials or AI performance evaluations. Therefore, most of the requested information related to clinical studies, AI performance, expert ground truth, and sample sizes for such studies is not applicable to this specific submission.

Summary

FDA 510(k) Clearance Letter - EMPOWR Revision Knee™

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 8, 2025

Encore Medical, L.P.
Morgan Paronish
Senior Regulatory Affairs Specialist
9800 Metric Boulevard
Austin, Texas 78758

Re: K251776
Trade/Device Name: EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)
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 10, 2025
Received: June 10, 2025

Dear Morgan Paronish:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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K251776 - Morgan Paronish Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K251776 - Morgan Paronish Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lixin Liu -S

Lixin Liu, Ph.D
Assistant Director
DHT6A: Division of Joint Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Page 4

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K251776

Device Name
EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)

Indications for Use (Describe)

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.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Revision VVC+, e+™ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:

Absence or loss of both cruciate ligaments
Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon
Bone loss that requires supplemental fixation in the clinical judgment of the surgeon

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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Office of Chief Information Officer
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PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) Summary

K251776 - Page 1 of 3

I. SUBMITTER

Encore Medical, L.P.
9800 Metric Blvd.
Austin, TX 78758

Contact Person: Morgan Paronish
Email: morgan.paronish@enovis.com
Phone: 317-519-5611
Date: July 8, 2025

II. DEVICE

Name of Device: EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)
Common or Usual Name: Total Knee Prosthesis
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis.
Regulation: 21 CFR 888.3560
Regulatory Class: II
Product Codes: JWH
Secondary Product Code: OIY

III. PREDICATE DEVICE

EMPOWR Revision VVC+, e+ Tibial Insert (K230169)

IV. DEVICE DESCRIPTION

V. 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;

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K251776 - Page 2 of 3

moderate valgus, varus or flexion deformities;
treatment of fractures that are unmanageable using other techniques.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring and reducing pain for many patients.

The EMPOWR Revision VVC+, e+™ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:

Absence or loss of both cruciate ligaments
Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon
Bone loss that requires supplemental fixation in the clinical judgment of the surgeon

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

There are no changes to technological characteristics being introduced with this submission except for the change in sterilization method. The addition of the VHP sterilization method for use with the EMPOWR Revision VVC+, e+ Tibial Insert does not affect the materials, design features, indications, or packaging of the implant. Verification and validation activities demonstrate substantial equivalence between the subject and predicate devices.

Verification and Validation

Risks were identified based on the proposed sterilization method and testing was conducted to mitigate those risks. Based on the risk analysis, the following tests were conducted.

Sterilization Validation
Shelf-Life Study
Packaging Testing
Cytotoxicity
Material Characterization
Pin-on-disk Wear
Lock Detail Fatigue
Tibial Post Fatigue

Animal Studies

No animal data submitted.

Clinical Studies

No clinical data submitted.

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K251776 - Page 3 of 3

VII. CONCLUSIONS

Based on the intended use, indications for use, and the technological differences supported by the verification and validation activities, the EMPOWR Revision Knee™ system with the VHP sterilized EMPOWR Revision VVC+, e+ Tibial Insert is substantially equivalent to the predicate system with the Hydrogen Peroxide Gas Plasma (HPGP) sterilized components.

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.