EMPOWR Dual Mobility (Metal Liner and Poly Bearing) is indicated as part of a total hip replacement for patients suffering from pain and dysfunction due to:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
Revision of previously failed total hip arthroplasty
Dislocation risks
To be used for uncemented applications

Device Description

EMPOWR Dual Mobility (Metal Liner and Poly Bearing) introduces a modular dual mobility bearing to the current acetabular system. The benefit of the new system is enhanced stability due to a larger femoral head with more ROM for a given cup size than the previously cleared single articulation liners. Bearings are offered in nominal OD sizes of 38-58mm compatible with previously cleared cups.

The subject bearing includes a Metal Liner made of CoCr alloy that locks to the cup with a modular taper junction and a Poly Bearing (Head) made from highly crossed linked UHMWPE infused with Vitamin E that captures an Inner Head made of ceramic or CoCr. The bearing provides two articulating surfaces. The Poly Bearing component articulates inside the Metal Liner and the permanently captured Inner Head articulates inside the Poly Bearing. The two articulations can occur independently or simultaneously.

AI/ML Overview

The provided text is a 510(k) summary for the EMPOWR Dual Mobility Metal Liner and Poly Bearing. This document indicates that clinical testing was not required for this device. Therefore, the comprehensive information regarding acceptance criteria and a study proving device performance as requested cannot be extracted from this document, as such a study was not performed or submitted for this regulatory clearance.

However, I can provide the available information:

A table of acceptance criteria and the reported device performance:
Since no clinical study was required or performed, there is no "reported device performance" in terms of clinical outcomes or specific acceptance criteria for clinical efficacy. The device's substantial equivalence was based on non-clinical mechanical testing.

Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
Demonstrated ability to perform under expected conditions for: Wear Testing, Metal Liner Disassembly, Head Disassembly, Metal Liner Corrosion, Impingement Testing, Range of Motion.	Mechanical testing demonstrated the device's ability to perform under expected conditions for all listed tests.
Pyrogen limit specifications met.	Device testing assures pyrogen limit specifications are met via Kinetic Chromogenic method for bacterial endotoxin testing.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable, as no clinical test set was used. Non-clinical testing would involve physical prototypes or samples rather than patient data.
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, as no clinical test set was used requiring expert ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set was used.
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 physical medical implant (hip replacement component), not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical study or patient data requiring ground truth was used for this submission. The "ground truth" for non-clinical mechanical testing would be the engineering specifications and performance expectations.
The sample size for the training set:
Not applicable, as no AI algorithm or clinical training set was used.
How the ground truth for the training set was established:
Not applicable, as no AI algorithm or clinical training set was used.

Summary

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February 10, 2021

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

Re: K203557

Trade/Device Name: EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH Dated: February 5, 2021 Received: February 8, 2021

Dear Teffany 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. 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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

Vesa Vuniqi 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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K203557

Device Name

EMPOWR Dual Mobility Metal Liner EMPOWR Dual Mobility Poly Bearing

Indications for Use (Describe)

EMPOWR Dual Mobility (Metal Liner and Poly Bearing) is indicated as part of a total hip replacement for patients suffering from pain and dysfunction due to:

· Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
· Correction of functional deformity
· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
Revision of previously failed total hip arthroplasty
· Dislocation risks
· To be used for uncemented applications

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Date: February 9, 2021

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: (760) 597-3466 Email: teffany.hutto@@djoglobal.com

Product	Common Name	Classification	Product Code
EMPOWR Dual Mobility Metal Liner
EMPOWR Dual Mobility Poly Bearing	Total Hip Implant	Class II	LPH

Product Code	Regulation and Classification Name
LPH	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesisper 888.3358

Description:

Indications for Use:

EMPOWR Dual Mobility (Metal Liner and Poly Bearing) is indicated as part of a total hip replacement for patients suffering from pain and dysfunction due to:

Noninflammatory degenerative joint disease including osteoarthritis and avascular ● necrosis
Rheumatoid arthritis
Correction of functional deformity ●
. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
Revision of previously failed total hip arthroplasty
Dislocation risks ●
To be used for uncemented applications ●

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Device	Manufacturer	510(k) Number
G7 Dual Mobility (Primary)	Biomet	K150522
Trident MDM (Reference)	Stryker	K103233
OR30 Dual Mobility (Reference)	Smith & Nephew	K191002
DJO EMPOWR Acetabular System (Reference)	DJO Surgical	K190057 K973119
DJO FMP Acetabular System (Reference)	DJO Surgical	K072888 K130365
DJO CoCr Femoral Heads (Reference)	DJO Surgical	K935449

Comparable Features to Predicate Device(s):

Intended Use and Indications for Use .
Materials
Design Features (Bearing Design, Modular Connection, Head/Cup Differential) ●
Poly Head/Inner Head Capture Feature
Bearing Surface ●
Size Range

There are no key differences in subject device to predicate

Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. This testing includes:

. Wear Testing
Metal Liner Disassembly
Head Disassembly
Metal Liner Corrosion ●
Impingement Testing ●
. Range of Motion

Based on the equivalent features, basic design, intended uses, and the comparative assessment included in this application, the EMPOWR Dual Mobility can be considered substantially equivalent to predicate devices.

Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.

Clinical Testing: Clinical testing was not required

Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.