ARTICUL/EZE Ceramic Heads
Device Facts
| Record ID | K222296 |
|---|---|
| Device Name | ARTICUL/EZE Ceramic Heads |
| Applicant | Depuy Ireland UC |
| Product Code | LZO · Orthopedic |
| Decision Date | Jan 6, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3353 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Total hip arthroplasty
Device Story
ARTICUL/EZE Ceramic Heads are zirconia-toughened alumina (ZTA) composite ceramic femoral head prostheses; used as a component in total hip arthroplasty systems. Device replaces diseased or damaged native femoral head; assembled intraoperatively with compatible femoral stem and acetabular component. Available in various outer diameters and offsets; utilizes 12/14 taper interface. Operated by orthopedic surgeons in clinical/hospital settings. Provides a bearing surface for hip joint articulation; restores joint function; reduces pain associated with hip pathologies. Performance verified via mechanical testing (compression, pull-off, torque, wear, impact) and biocompatibility assessment.
Clinical Evidence
No clinical tests were conducted. Substantial equivalence is supported by non-clinical bench testing, including static compression, axial pull-off, torque-off, wear testing per ISO 14242-1:2014, material wear after aging per ISO 6474-2:2019, impact strength per ISO 11491:2017, MRI safety evaluation, and biocompatibility testing per ISO 10993-1:2018.
Technological Characteristics
Material: Zirconia-toughened alumina (ZTA) ceramic compliant with ISO 6474-2:2019. Interface: 12/14 taper. Form factor: Femoral head prosthesis with various outer diameters and offsets. Sterilization: Standardized method (SAL, packaging, and shelf-life equivalent to predicates).
Indications for Use
Indicated for patients with severely painful and/or disabled hip joints due to 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 (joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement); or certain cases of ankylosis.
Regulatory Classification
Identification
A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.
Predicate Devices
Reference Devices
- ICONACY I-Hip (K151307)
Submission Summary (Full Text)
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January 6, 2023
Depuy Ireland UC Paige Myers Regulatory Affairs Specialist Loughbeg, Ringaskiddy Cork Ireland
Re: K22296
Trade/Device Name: ARTICUL/EZE Ceramic Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO Dated: December 2, 2022 Received: December 2, 2022
Dear Paige Myers:
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.
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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 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 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).
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 Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
Device Name
ARTICUL/EZE Ceramic Femoral Heads
Indications for Use (Describe)
#### INDICATIONS FOR USE
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, 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, arthrodesis, hemiarthroplasty, surface
replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
| 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)
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## 510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | DePuy Ireland UC |
| Address | Loughbeg, Ringaskiddy<br>Co. Cork Munster, IRELAND |
| Establishment Registration<br>Number | 3015516266 |
| Name of contact person | Paige Myers |
| E-Mail Address | pmyers1@its.jnj.com and<br>DePuySynthesJointsRegulatoryAffairs@its.jnj.com |
| Alternate Contact Person | Clare Hill |
| Alternate Contact E-Mail | Chill7@its.jnj.com |
| Alternate Contact Phone | +44 7795 389956 (UK time zone) |
| Date prepared | 6 January 2023 |
| Name of device | |
| Trade or proprietary name | ARTICUL/EZE Ceramic Heads |
| Common or usual name | Ceramic femoral ball prosthesis |
| Classification name | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous<br>uncemented prosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3353 |
| Product Code(s) | LZO |
| Legally marketed device(s) to<br>which equivalence is claimed | Primary Predicate Device: DEPUY CERAMIC FEMORAL HEADS:<br>K031803<br>Secondary Predicate Device: ARTICUL/EZE FEMORAL HEADS:<br>K980513<br>Reference Device: ICONACY I-Hip K151307 |
| Reason for 510(k) submission | The purpose of this 510K submission is to obtain market clearance for<br>ARTICUL/EZE Ceramic Heads |
| Device description | The ARTICUL/EZE Ceramic Heads are a zirconia toughened alumina<br>composite ceramic femoral head designed to be used as one component of a |
| system of prostheses in hip arthroplasty. The femoral heads are available in a<br>wide range of outer diameter sizes and offsets. | |
| Intended use of the device | Total hip arthroplasty |
| Indications for use | Total hip replacement is indicated in the following conditions:<br>1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,<br>rheumatoid arthritis, or congenital hip dysplasia.<br>2. Avascular necrosis of the femoral head.<br>3. Acute traumatic fracture of the femoral head or neck.<br>4. Failed previous hip surgery including joint reconstruction, internal fixation,<br>arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.<br>5. Certain cases of ankylosis. |
| Performance Testing | The ARTICUL/EZE Ceramic Heads were tested to demonstrate the substantial<br>equivalence to the identified predicate devices. Testing and analyses included:<br>Static Compression (Burst) testing per ISO 7206-10:2018 Axial Pull-off testing per ISO 7206-10:2018 Torque-off testing per ISO 7206-13:2016 Wear testing per ISO 14242-1:2014 Material Wear after Aging testing per ISO 6474-2:2019 Impact strength per ISO 11491:2017 MRI Safety Evaluation testing per ISO 14630:2012 Biocompatibility testing per 10993-1:2018 Bacterial endotoxin per ANSI/AAMI ST 72:2019 |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE | | | | | |
|---------------------------------------------------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Characteristics | Subject Device:<br>ARTICUL/EZE Ceramic<br>Heads | Primary Predicate Device:<br>DEPUY CERAMIC<br>FEMORAL HEADS<br>(K031803) | Secondary Predicate Device:<br>ARTICUL/EZE COCR<br>FEMORAL HEADS<br>(K980513) | Reference Device:<br>ICONACY I-Hip (K151307) | |
| Intended Use | Same as primary predicate<br>device | Intended for use in total hip<br>arthroplasty | Same as primary predicate<br>device | Same as primary predicate<br>device | |
| Indications for<br>Use | Same as primary predicate<br>device | Total hip replacement is<br>indicated in the following<br>conditions:<br>1. A severely painful and/or<br>disabled joint from<br>osteoarthritis, traumatic<br>arthritis, rheumatoid arthritis,<br>or congenital hip dysplasia.<br>2. Avascular necrosis of the<br>femoral head.<br>3. Acute traumatic fracture of<br>the femoral head or neck.<br>4. Failed previous hip surgery<br>including joint reconstruction,<br>internal fixation, arthrodesis,<br>hemiarthroplasty, surface<br>replacement arthroplasty, or<br>total hip replacement.<br>5. Certain cases of ankylosis. | Total hip replacement is<br>indicated in the following<br>conditions:<br>1. A severely painful and/or<br>disabled joint from<br>osteoarthritis, traumatic<br>arthritis, or rheumatoid arthritis<br>2. Avascular necrosis of the<br>femoral head.<br>3. Acute traumatic fracture of<br>the femoral head or neck.<br>4. Failed previous hip surgery<br>including joint reconstruction,<br>internal fixation, arthrodesis,<br>hemiarthroplasty, surface<br>replacement arthroplasty, or<br>total hip replacement.<br>5. Certain cases of ankylosis. | 1. A severely painful and/or<br>disabled hip joint as a result of<br>osteoarthritis, traumatic<br>arthritis, rheumatoid arthritis,<br>or congenital hip dysplasia.<br>2. Avascular necrosis of the<br>femoral head.<br>3. Acute traumatic fracture of<br>the femoral head or neck.<br>4. Failed previous hip surgery<br>including joint reconstruction,<br>internal fixation, arthrodesis,<br>hemiarthroplasty, surface<br>replacement arthroplasty, or<br>total hip replacement.<br>5. Certain cases of ankylosis<br>6. Nonunions, correction of<br>functional deformity, and<br>trochanteric fractures of the<br>proximal femur with head<br>involvement that are<br>unmanageable using other<br>techniques. | |
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| | Cerasurf-w, a Zirconia-toughened<br>Alumina Ceramic (ZTA)<br>(ISO 6474-2:2019) | CeramTec BIOLOX® delta, a<br>Zirconia-toughened Alumina<br>Ceramic (ZTA)(ISO 6474-2:2019) | CoCrMo (ASTM F1537-11) | Ceramic heads: Cerasurf-p, a<br>Zirconia-toughened Alumina<br>Ceramic (ZTA)(ISO 6474-2:2019) |
|-------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Material | | | | |
| Outer Diameter<br>Sizes | Same as secondary predicate<br>device | 28mm, 32mm, 36mm | 22.225mm, 28mm, 32mm,<br>36mm, 40mm | 28mm, 32mm, 36mm |
| Taper | Same as primary predicate<br>device | 12/14 ARTICUL/EZE taper | Same as primary predicate<br>device | 12/14 taper |
| Offsets | Same as secondary predicate<br>device | 28mm: +1.5, +5, +8.5<br>32mm: +1, +5, +9<br>36mm: +1.5, +5, +8.5, +12 | 22.225mm: +4, +7<br>28mm: +1.5, +5, +8.5,<br>32mm: +1, +5, +9<br>36mm: -2, +1.5, +5, +8.5, +12<br>40mm: -2, +1.5, +5, +8.5, +12 | 28mm: -4, +0, +4<br>32mm: -4, +0, +4, +7<br>36mm: -4, +0, +4, +8 |
The subject device has the same intended use and inte primary and secondary predicate devices. They are all femoral heads that are intended to replace diseased or broken femoral head and neck bone in combination with a femoral stem prosthesis. They all replace the native femoral head and are assembled intraoperatively with a compatible femoral stem to acetabular component. The subject devices and both predicate devices are intended for total hip arthroplasty and are compatible with 12/14 ARTICULEZE Tapers. The subject device have icentral sizes and offsets. The subject devices have the same method of sterlization. Sterility Asurance Level (SAL), packaging materials, and sheff-life. The ARTICUL/EZE Ceramic Heads are similar to the predicate DEPUY CERAMIC FEMORAL HEADS (K031803) and the predicate ARTICUL/EZE COCR FEMORAL HEADS (K980513) in design. Both the subject device, the primary predicate, and the reference device ICONACY I-Hin (K151307) are made of a zirconia toughened alumina (ZTA) ceramic that is compliant to ISO 6474-2:2019.
The reference device was used to demonstrate biological safety and equivalence for the manufacturing process and raw material of the subject device.
Results of performance testing and analyses demonstrate that the ARTICUL/EZE Ceramic Heads perform as well as the predicate devices.
## SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were conducted to demonstrate substantial equivalence.
### CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject ARTICUL/EZE Ceramic Heads are substantially equivalent to the predicate DEPUY CERAMIC FEMORAL HEADS (K031803) and ARTICUL/EZE COCR FEMORAL HEADS (K980513)
