The EMPOWR Revision Knee™ Symmetric TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon. The EMPOWR Revision Knee™ Symmetric TT Cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Indications for Use:

The EMPOWR Revision Knee™:

Total 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.

This device may also be indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves cones or extensions.

The EMPOWR Revision Knee™ Symmetric TT Cones are indicated for the following conditions:

EMPOWR Revision Knee™ Symmetric TT Cones are indicated for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon.
EMPOWR Revision Knee™ Symmetric TT Cones are indicated for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Device Description

The EMPOWR Revision Knee™ Symmetric TT (Trabecular Titanium) Cones are an optional accessory in primary or revision Total Knee Arthroplasty. The EMPOWR Symmetric TT Cones are sterile, single-use devices that are compatible for use with the EMPOWR Revision Knee™ components. The EMPOWR Symmetric TT Cones are composed of Ti6Al4V alloy (per ASTM F1472 and ISO 5832-3) and feature a porous Trabecular Titanium (TT) structure on the external surface of the implant. The EMPOWR Symmetric TT Cones are additively manufactured via Electron Beam Melting in the same manner as the reference AMF TT Cones device.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device: the EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones).

It is crucial to understand that this document DOES NOT contain information about acceptance criteria or specific studies proving the device meets those criteria in the context of an AI/ML medical device.

The 510(k) clearance process for this orthopedic implant relies on demonstrating substantial equivalence to a previously cleared predicate device, primarily through bench testing (mechanical performance) and, in some cases, clinical data if significant differences exist. This is a very different type of clearance than for AI/ML devices, which require performance data related to algorithmic accuracy or clinical utility.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes for test/training sets, experts, adjudication, MRMC, standalone performance, ground truth establishment) because it is not present in this document.

The document states:

"No animal data submitted."
"No clinical data submitted."
"All testing and evaluations demonstrate that the subject device is substantially equivalent to the primary predicate."

The performance testing listed focuses on mechanical properties (Dynamic Fatigue Testing, MR Conditional Labeling), which are relevant for an orthopedic implant but entirely different from the performance metrics and study designs expected for an AI/ML diagnostic or assistive device.

In summary, the provided document does not support a response to the prompt's specific questions regarding acceptance criteria and performance data for an AI/ML device.

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 2, 2025

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

Re: K251241
Trade/Device Name: EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)
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, MBH
Dated: April 21, 2025
Received: April 22, 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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K251241 - 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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K251241 - 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

Enclosure

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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): K251241

Device Name: EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

Indications for Use (Describe)

Total 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.

This device may also be indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves cones or extensions.

The EMPOWR Revision Knee™ Symmetric TT Cones are indicated for the following conditions:

EMPOWR Revision Knee™ Symmetric TT Cones are indicated for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon.
EMPOWR Revision Knee™ Symmetric TT Cones are indicated for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

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
Paperwork Reduction Act (PRA) Staff
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

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

II. DEVICE

Trade Name: EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)
Common Name: Total Knee Prosthesis
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis.
Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
Regulation: 21 CFR 888.3560 / 21 CFR 888.3565
Regulatory Class: II
Primary Product Code: JWH
Secondary Product Code: MBH

III. PREDICATE / REFERENCE DEVICES

Predicate (primary): EMPOWR Revision Knee™ Symmetric Cones (K240324)
Predicate (secondary): EMPOWR Revision VVC+, e+ Tibial Insert (K230169)
Reference: AMF TT Cones (K200653)

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE / INTENDED USE

Intended Use:

The EMPOWR Revision Knee™ Symmetric TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires

K251241 Page 1 of 3

Page 6

supplemental fixation in the clinical judgment of the surgeon. The EMPOWR Revision Knee™ Symmetric TT Cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Indications for Use:

The EMPOWR Revision Knee™:

Total 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.

This device may also be indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves cones or extensions.

The EMPOWR Revision Knee™ Symmetric TT Cones are indicated for the following conditions:

EMPOWR Revision Knee™ Symmetric TT Cones are indicated for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon.
EMPOWR Revision Knee™ Symmetric TT Cones are indicated for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject EMPOWR Revision Knee™ Symmetric TT Cones have similar technological characteristics as the primary predicate EMPOWR Revision Knee™ Symmetric Cones.

The subject and primary predicate have the same substrate material, size offerings, sterility, method of fixation, and cones specific indications for use. The subject and secondary predicate have identical indications for use for joint replacement.

The subject and primary predicate differ in manufacturing process, coating, and packaging. The manufacturing process and coating are identical to the AMF TT Cones reference device. Packaging testing provided evidence that the new configuration is able to protect the product and maintain sterility.

Performance testing demonstrates substantial equivalence between the subject and predicate device.

Performance Testing

The following testing was performed to FDA recognized standards and internal protocols:

Dynamic Fatigue Testing: ASTM F1800-19e1 (modified)
MR Conditional Labeling: ASTM F2052 -21, ASTM F2213-17, ASTM F2119-07(2013), ASTM F2182-10e2

K251241 Page 2 of 3

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Animal Studies
No animal data submitted.

Clinical Studies
No clinical data submitted.

VIII. CONCLUSIONS

All testing and evaluations demonstrate that the subject device is substantially equivalent to the primary predicate.

K251241 Page 3 of 3

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.