EMPHASYS Acetabular System

• K Number: K243977
• Device Name: EMPHASYS Acetabular System
• Manufacturer: DePuy Ireland UC
• Date Cleared: 2025-01-22 ( 30 days)
• Product Code: LPH , LZO
• Regulation Number: 888.3358
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K221636 , K071784 , K231873
• Predicate For: N/A

Intended Use

The EMPHASYS Acetabular System is indicated for use in total hip replacement procedures.
Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   EMPHASYS Acetabular Cups are indicated for cementless use only.

Device Description

The subject devices in this line extension to the EMPHASYS Acetabular System (previously cleared through Primary Predicate 510(k) K221636) include three additional porous-coated titanium alloy Acetabular Shells in a multi-hole configuration and ten corresponding AOX polyethylene Acetabular Liners in three configurations (Neutral, +4 Neutral and ELV)

AI/ML Overview

This is a medical device submission, not a software or AI device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable in the context of this document. This document pertains to the clearance of an acetabular system for total hip replacement, which involves physical device testing and comparison to predicate devices, not algorithmic performance.

Here's why each point is not applicable:

• A table of acceptance criteria and the reported device performance: This usually applies to diagnostic or AI algorithms where performance metrics like sensitivity, specificity, AUC are relevant. For a physical orthopedic implant, performance is assessed through mechanical and material testing against established standards, not necessarily a concise table of "acceptance criteria" as would be seen for software. The document states that testing was done for "Interconnection strength of shell and liner per ASTM F1820-22," implying adherence to a standard, but does not provide specific acceptance values or results in this summary.
• Sample sized used for the test set and the data provenance: Not applicable for a physical implant. "Test set" in an AI/software context refers to data. Here, it refers to physical units of the device tested in a lab.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is generally for classification/detection tasks. For an implant, "ground truth" would be the physical properties confirmed through engineering tests.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in expert reviews of data/images.
• 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 is for AI-assisted diagnostic tools, not an orthopedic implant.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, ground truth relates to its material properties and mechanical performance confirmed by standardized testing, not expert consensus on medical images or pathology.
• The sample size for the training set: Not applicable. This is for AI/machine learning models.
• How the ground truth for the training set was established: Not applicable. This is for AI/machine learning models.

Summary of Relevant Information (from the document) for a Physical Device:

• Performance Testing: The EMPHASYS Acetabular System subject devices were compared to predicate devices. Testing and analyses included:

  • Interconnection strength of shell and liner per ASTM F1820-22.
  • No new worst-case was identified for: Range of motion, Deformation, Impingement, Unsupported Shell Fatigue, Analysis of shell and liner thickness, Articular clearance, Wear Friction, MRI Safety.

• Substantial Equivalence: The device is substantially equivalent to identified predicates with respect to intended use, indications, materials, geometry, range of sizes, and method of fixation. Performance testing and analyses demonstrate that it performs as well as the predicate devices.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 21, 2025

DePuy Ireland UC Amy Joyce Senior Regulatory Affairs Associate Loughbeg Ringaskiddy Co. Cork. Ireland

Re: K243977

Trade/Device Name: EMPHASYS Acetabular 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: December 19, 2024 Received: December 23, 2024

Dear Amy Joyce:

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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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 (OS) 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-device-advicecomprehensive-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-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

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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,

Image /page/2/Picture/3 description: The image contains the text "Limin Sun -S" in a large, sans-serif font. The text is black and is set against a white background. The words "Limin" and "Sun" are separated by a space, and "Sun" is followed by a hyphen and the letter "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

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Indications for Use

Submission Number (if known)

K243977

Device Name

EMPHASYS Acetabular System

Indications for Use (Describe)

The EMPHASYS Acetabular System is indicated for use in total hip replacement procedures.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,

hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

EMPHASYS Acetabular Cups are indicated for cementless use only.

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)

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510(k) Summary

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg, RingaskiddyCo. Cork, IRELAND
Establishment RegistrationNumber	3015516266
Name of contact person	Amy Joyce
e-mail address	[e-mail]
Alternative contact person	Elaine Pears
e-mail address	[e-mail]
Work mobile	[phone] (UK time zone)
Date prepared	19th December 2024
Name of device
Trade or proprietary name	EMPHASYS Acetabular System
Common or usual name	Total Hip Arthroplasty Prosthesis
Classification name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented OrNon-Porous, Uncemented
Class	II
Classification panel	87 Orthopedics
Regulation	21 CFR 888.3358; 888.3353
Product Code(s)	LPH; LZO
Legally marketed device(s)to which equivalence isclaimed	Primary predicate – EMPHASYS Acetabular System K221636Secondary predicate – DePuy PINNACLE with Gription Acetabular CupsK071784Secondary predicate – PINNACLE Marathon Liners (DePuy Hip Portfolio –MR Conditional) K231873
Reason for 510(k)submission	The purpose of this 510(k) submission is to expand the scope of the legallymarketed DePuy Synthes EMPHASYS Acetabular System to includeadditional sizes.
Device description	The subject devices in this line extension to the EMPHASYS Acetabular System(previously cleared through Primary Predicate 510(k) K221636) include threeadditional porous-coated titanium alloy Acetabular Shells in a multi-holeconfiguration and ten corresponding AOX polyethylene Acetabular Liners inthree configurations (Neutral, +4 Neutral and ELV)
Intended use of the device	The system is intended for use with a compatible DePuy femoral stem andfemoral head as a total hip prosthesis.
Indications for use	Total hip replacement is indicated in the following conditions:1. A severely painful and/or disabled joint from osteoarthritis, traumaticarthritis, rheumatoid arthritis, or congenital hip dysplasia.2. Avascular necrosis of the femoral head.3. Acute traumatic fracture of the femoral head or neck.4. Failed previous hip surgery including joint reconstruction, internalfixation, arthrodesis, hemiarthroplasty, surface replacementarthroplasty, or total hip replacement.5. Certain cases of ankylosis.EMPHASYS Acetabular Cups are indicated for cementless use only.
Performance Testing	The EMPHASYS Acetabular System subject devices were compared to thepredicate devices and assessed for worst-case, only those situations where anew worst-case was identified were testing conducted. No new worst-case wasidentified for the following:Range of motion Deformation Impingement Unsupported Shell Fatigue Analysis of shell and liner thickness Articular clearance Wear Friction MRI Safety The EMPHASYS Acetabular System subject devices were tested to demonstrate substantial equivalence to the identified predicate devices. Testing and analyses included: Interconnection strength of shell and liner per ASTM F1820-22
Substantial Equivalence	The EMPHASYS Acetabular System is substantially equivalent to the identified predicates with respect to intended use, indications, materials, geometry, range of sizes, and method of fixation. Results of performance testing and analyses demonstrates that the EMPHASYS Acetabular System performs as well as the predicate devices.

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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.