Who is the manufacturer of EMPHASYS Dual Mobility System?

Depuy Ireland UC filed the 510(k) submission for EMPHASYS Dual Mobility System (K231522).

What is the FDA product code for EMPHASYS Dual Mobility System?

LPH. It is classified under 21 CFR 888.3358 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for EMPHASYS Dual Mobility System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for EMPHASYS Dual Mobility System?

PINNACLE Dual Mobility Liners (K200854); BI-MENTUM Dual Mobility System (K181744).

Who can help prepare an FDA 510(k) submission like EMPHASYS Dual Mobility System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EMPHASYS Dual Mobility System

K231522 · Depuy Ireland UC · LPH · Feb 15, 2024 · Orthopedic

Device Facts

Record ID	K231522
Device Name	EMPHASYS Dual Mobility System
Applicant	Depuy Ireland UC
Product Code	LPH · Orthopedic
Decision Date	Feb 15, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3358
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The EMPHASYS Dual Mobility System is designed to provide additional stability where there is an unstable joint and is for use in total hip arthroplasty, which is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Device Story

The EMPHASYS Dual Mobility System is a hip arthroplasty prosthesis consisting of Co-Cr-Mo dual mobility liners and AOX polyethylene mobile bearing heads. It is designed for cementless implantation in patients undergoing total hip replacement. The device functions as an artificial hip joint articulation, replacing damaged bone surfaces to restore mobility and reduce pain. It provides increased joint stability, particularly for patients at risk of dislocation. The system is used by orthopedic surgeons in a clinical/surgical setting. By replacing the natural joint with these components, the device aims to improve patient function and quality of life. It is compatible with previously cleared hip system components.

Clinical Evidence

No clinical data. Substantial equivalence is supported by extensive bench testing, including ISO 14242-1/2/4 wear testing (standard, high angle, and third-body abrasive), ASTM F2582-20 impingement testing, ASTM F1820-22 liner fixation testing (push-out, pull-out, torque-out), ASTM F1875 Method I testing, and MRI safety evaluations per ASTM F2503-23 and related standards.

Technological Characteristics

Liners: Cobalt-chromium-molybdenum alloy (CoCrMo) per ASTM F1537. Mobile Bearing Heads: AOX Polyethylene. Fixation: Cementless. Testing standards include ISO 21535:2007 (ROM), ASTM F2582-20 (impingement), ASTM F1820-22 (liner fixation), ISO 14242 series (wear), ASTM F3143-20 (friction), and various ASTM standards for MRI safety (F2503-23, F2182-19e2, F2052-21, F2213-17, F2119-07).

Indications for Use

Indicated for patients requiring total hip replacement due to severely painful and/or disabled joints (typically non-inflammatory degenerative joint disease), failed previous hip surgery, or dislocation risks. Intended for cementless 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

PINNACLE Dual Mobility Liners (K200854)
BI-MENTUM Dual Mobility System (K181744)

Reference Devices

Stryker MDM Acetabular System (K103233)
Zimmer Biomet G7 Dual Mobility (K150522)
DePuy SUMMIT Porocoat Hip Prosthesis (K231873)
DePuy SUMMIT DuoFix Hip Prosthesis (K231873)
DePuy SUMMIT Cemented Hip Prosthesis (K231873)
DePuy SUMMIT FX Cemented Hip Prosthesis (K231873)
DePuy SUMMIT Basic Press-Fit Hip Prosthesis (K231873)
EMPHASYS Acetabular AOX Liners (K221636)
Smith & Nephew OR3O (K232667)

Related Devices

K190535 — BiMobile Dual Mobility System - E-Dur Inserts · Waldemar Link GmbH & Co. KG · Aug 6, 2019
K221636 — EMPHASYS Acetabular System · Depuy Ireland UC · Sep 6, 2022
K171273 — LINK® BiMobile(TM) Dual Mobility System · Waldemar Link GmbH & Co. KG · Jan 19, 2018
K181491 — Delta Dual Mobility System · Lima Corporate S.P.A. · May 9, 2019
K243977 — EMPHASYS Acetabular System · Depuy Ireland UC · Jan 22, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 15, 2024 DePuy Ireland UC Farah Valli Project lead Regulatory Affairs Loughbeg, Ringaskiddy Co. Cork Ireland Re: K231522 Trade/Device Name: EMPHASYS™ Dual Mobility System 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, LZO Dated: January 19, 2024 Received: January 19, 2024 Dear Farah Valli: 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 (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/cdrb/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. {1}------------------------------------------------ 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 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-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 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. 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-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). {2}------------------------------------------------ Sincerely, # Limin Sun -S Limin Sun, 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 {3}------------------------------------------------ ### Indications for Use Submission Number (if known) K231522 Device Name EMPHASYS™ Dual Mobility System Indications for Use (Describe) Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease). 2. Failed previous hip surgery. 3. Dislocation risks. EMPHASYS Dual Mobility Liners and Mobile Bearing Heads are intended for cementless applications. 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 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." {4}------------------------------------------------ ## 510(K) SUMMARY (As required by 21 CFR 807.87(h)) | | Submitter Information | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | DePuy Ireland UC | | Address | Loughbeg, Ringaskiddy Co. Cork, IRELAND | | Phone number | 574-372-7211 | | Fax number | 574-371-4987 | | Establishment Registration Number | 3015516266 | | Name of contact person | Farah Valli | | Date prepared | 15 Feb 2024 | | | Name of device | | Trade or proprietary name | EMPHASYST™ Dual Mobility System | | Common or usual name | Total Hip Arthroplasty Prosthesis | | Classification name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | | Class | II | | Classification panel | 87 Orthopedics | | Regulation | 888.3358; 888.3353 | | Product Code(s) | LPH; LZO | {5}------------------------------------------------ | Legally marketed device(s) to which equivalence is claimed | Subject Device: EMPHASYS Dual Mobility Liners | Predicate Device: DePuy PINNACLE Dual Mobility Liners (K200854) | Reference Devices: Stryker MDM Acetabular System (K103233) Zimmer Biomet G7 Dual Mobility (K150522) DePuy SUMMIT Porocoat Hip Prosthesis - MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis - MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis - MR Conditional, DePuy SUMMIT Basic Press- Fit Hip Prosthesis – MR Conditional (K231873) | |---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device: EMPHASYS Mobile Bearing Heads | Predicate Device: BI-MENTUM Dual Mobility System (K181744) | Reference Devices: EMPHASYS Acetabular AOX Liners (K221636) Zimmer Biomet G7 Dual Mobility (K150522) Smith & Nephew OR3O (K232667) DePuy SUMMIT Porocoat Hip Prosthesis - MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis - MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis - MR Conditional, DePuy SUMMIT Basic Press- Fit Hip Prosthesis - MR Conditional (K231873) | | Reason for 510(k) submission | The purpose of this 510(k) submission is to obtain market clearance for the DePuy EMPHASYS Dual Mobility System. | | | | Device description | The EMPHASYS Dual Mobility System includes Co-Cr-Mo Dual Mobility Liners and AOX Polyethylene Mobile Bearing Heads as well as other previously cleared compatible components. | | | | Intended use of the device | The EMPHASYS Dual Mobility System is designed to provide additional stability where there is an unstable joint and is for use in total hip arthroplasty, which is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. | | | {6}------------------------------------------------ | Indications for use | Total hip replacement is indicated in the following conditions: A severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease). Failed previous hip surgery. Dislocation risks. EMPHASYS Dual Mobility Liners and EMPHASYS Mobile Bearing Heads are intended for cementless applications. | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison of Technological Characteristics | The EMPHASYS Dual Mobility System proposes no new applications, intended use, or indications relative to the predicate devices. The material of construction of the EMPHASYS Dual Mobility Liners is identical to that of the predicate (Cobalt- chromium-molybdenum alloy (CoCrMo) conforming to ASTM F1537). The EMPHASYS Mobile Bearing Heads are manufactured from AOX Polyethylene, identical to the reference device (EMPHASYS Acetabular AOX Liners (K221636)). While there are minor differences in design between the subject devices and the predicate/reference devices, DePuy has provided comparative testing to demonstrate equivalence with existing products. | | Performance Testing | The EMPHASYS Dual Mobility System was tested to demonstrate its substantial equivalence to the identified predicate devices. Testing and analyses included: EMPHASYS Mobile Bearing Head Thickness Assessment EMPHASYS Dual Mobility Liner Thickness Assessment Range of Motion Analysis- ISO 21535:2007 EMPHASYS Mobile Bearing Head Impingement-ASTM F2582-20 EMPHASYS Dual Mobility Impingement Testing to ASTM F2582-20 EMPHASYS Dual Mobility Liner Push-Out- ASTM F1820-22 EMPHASYS Dual Mobility Liner Offset Pull-Out- ASTM F1820-22 EMPHASYS Dual Mobility Liner Torque-Out- ASTM F1820-22 EMPHASYS Mobile Bearing Head Lever-Out EMPHASYS Dual Mobility ASTM F1875 Method I Test EMPHASYS Dual Mobility Non-Aged Standard Walking Wear Test- ISO 14242-1:2014 and ISO 14242-2:2016. EMPHASYS Dual Mobility Standard Walking with Mode 3 Third Body Abrasive Wear Test - ISO 14242-1:2014, ISO 14242-1 AMD 1:2018, ISO 14242-2:2016 and ISO 14242-4:2018. | | | EMPHASYS Dual Mobility High Angle Standard Walking Wear Test- ISO 14242-1:2014, ISO 14242-2:2016 and ISO 14242-4:2018. EMPHASYS Dual Mobility Worst Case Outer Bearing Wear of EMSYS DM under Standard Walking Wear- ISO 14242-1:2014 and ISO 14242-2:2016 EMPHASYS Dual Mobility Friction Test- ASTM F3143-20 MRI Safety Evaluation Testing of Total Hip Systems- ASTM F2503-23, ASTM F2182 -19e2, ASTM F2052-21, ASTM F2213-17, and ASTM F2119-07 | | Substantial Equivalence | The EMPHASYS Dual Mobility System is substantially equivalent to the identified predicates with respect to intended use, indications, materials, geometry, and method of fixation. Results of performance testing and analyses demonstrate that the EMPHASYS Dual Mobility System performs as well as the predicate devices. | {7}------------------------------------------------