EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing

K203557 · Encore Medical L.P. · LPH · Feb 10, 2021 · Orthopedic

Device Facts

• Record ID: K203557
• Device Name: EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
• Applicant: Encore Medical L.P.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Modular dual mobility hip implant system; consists of CoCr metal liner and Vitamin E-infused highly cross-linked UHMWPE poly bearing. Device provides two articulating surfaces: poly bearing inside metal liner and inner head (ceramic or CoCr) inside poly bearing. Enhances stability and range of motion (ROM) via larger femoral head compared to single articulation liners. Used in total hip arthroplasty; implanted by orthopedic surgeons in clinical/OR settings. Benefits include reduced dislocation risk and improved joint stability. System is compatible with previously cleared acetabular cups.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including wear testing, metal liner and head disassembly, metal liner corrosion, impingement testing, and range of motion analysis.

Technological Characteristics

Modular dual mobility acetabular bearing system. Materials: CoCr alloy (metal liner), Vitamin E-infused highly cross-linked UHMWPE (poly bearing). Articulation: Dual-bearing surface. Sizes: 38-58mm nominal OD. Uncemented application. No software or electronic components.

Indications for Use

Indicated for patients requiring total hip replacement due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (non-union, femoral neck, trochanteric), or revision of failed arthroplasty. Indicated for patients at risk of dislocation. For uncemented applications.

Regulatory Classification

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.

Predicate Devices

• G7 Dual Mobility (K150522)

Reference Devices

• Trident MDM (K103233)
• OR30 Dual Mobility (K191002)
• DJO EMPOWR Acetabular System (K190057, K973119)
• DJO FMP Acetabular System (K072888, K130365)
• DJO CoCr Femoral Heads (K935449)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.

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 Food and Drug Administration 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."

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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: [phone] Fax: [phone] 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 prosthesis<br>per 888.3358 |

## 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.

## 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<br>K973119 |
| DJO FMP Acetabular System (Reference) | DJO Surgical | K072888<br>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.