(30 days)
Not Found
No
The document describes a mechanical implant (acetabular system) and its components, with no mention of AI/ML in the intended use, device description, or performance studies.
Yes.
The device is an acetabular system used in total hip replacement procedures, which is a therapeutic intervention for various painful and disabling hip conditions.
No
This device is an acetabular system used in total hip replacement procedures, which is a treatment for certain hip conditions, not a diagnostic tool for identifying a disease or condition.
No
The device description clearly states it includes physical components: porous-coated titanium alloy Acetabular Shells and polyethylene Acetabular Liners. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total hip replacement procedures, which is a surgical intervention on the human body. IVDs are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is an acetabular system (hip implant components), which is a physical implant placed within the body. IVDs are typically reagents, instruments, or systems used to perform tests on specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the EMPHASYS Acetabular System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EMPHASYS Acetabular System is indicated for use in total hip replacement procedures.
Total hip replacement is indicated in the following conditions:
- A severely painful and and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
EMPHASYS Acetabular Cups are indicated for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The EMPHASYS Acetabular System subject devices were compared to the predicate devices and assessed for worst-case, only those situations where a new worst-case was identified were testing conducted. No new worst-case was identified 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Primary predicate – EMPHASYS Acetabular System K221636, Secondary predicate – DePuy PINNACLE with Gription Acetabular Cups K071784, Secondary predicate – PINNACLE Marathon Liners (DePuy Hip Portfolio – MR Conditional) K231873
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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:
-
A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
Avascular necrosis of the femoral head.
-
Acute traumatic fracture of the femoral head or neck.
-
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- 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, Ringaskiddy |
| Co. Cork, IRELAND | |
| Establishment Registration | |
| Number | 3015516266 |
| Name of contact person | Amy Joyce |
| e-mail address | AJoyce1@its.jnj.com |
| DePuySynthesJointsRegulatoryAffairs@its.jnj.com | |
| Alternative contact person | Elaine Pears |
| e-mail address | EPears@its.jnj.com |
| Work mobile | +44 7876217532 (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 Uncemented |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or | |
| Non-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 is | |
| claimed | Primary predicate – EMPHASYS Acetabular System K221636 |
| Secondary predicate – DePuy PINNACLE with Gription Acetabular Cups | |
| K071784 | |
| Secondary 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 legally |
| marketed DePuy Synthes EMPHASYS Acetabular System to include | |
| additional sizes. | |
| 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) | |
| Intended use of the device | The system is intended for use with a compatible DePuy femoral stem and |
| femoral head as a total hip prosthesis. | |
| Indications for use | Total hip replacement is indicated in the following conditions: |
- A severely painful and/or disabled joint from osteoarthritis, traumatic
arthritis, rheumatoid arthritis, or congenital hip dysplasia. - Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal
fixation, arthrodesis, hemiarthroplasty, surface replacement
arthroplasty, or total hip replacement. - Certain cases of ankylosis.
EMPHASYS Acetabular Cups are indicated for cementless use only. |
| Performance Testing | The EMPHASYS Acetabular System subject devices were compared to the
predicate devices and assessed for worst-case, only those situations where a
new worst-case was identified were testing conducted. No new worst-case was
identified 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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