(158 days)
No
The summary describes a ceramic femoral head, a passive implantable device, and the performance testing focuses on mechanical properties and biocompatibility. There is no mention of software, algorithms, or any computational processing that would suggest AI/ML.
Yes.
The device is a component of a prosthesis intended to treat conditions like severely painful/disabled joints, avascular necrosis, and traumatic fractures.
No
The device description indicates it is a prosthetic component for hip replacement surgery, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a ceramic femoral head, which is a physical implant component used in hip replacement surgery, not software. The performance studies also focus on physical properties and testing of the ceramic head.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip replacement, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a ceramic femoral head, a component of a hip prosthesis. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or analytical methods.
The testing performed (mechanical testing, wear testing, biocompatibility, etc.) is consistent with the evaluation of a surgical implant, not an IVD.
N/A
Product codes (comma separated list FDA assigned to the subject device)
LZO
Intended Use / Indications for Use
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
Device Description
The ARTICUL/EZE Ceramic Heads are a zirconia toughened alumina 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 wide range of outer diameter sizes and offsets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint / femoral head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 ARTICUL/EZE Ceramic Heads were tested to demonstrate the substantial equivalence to the identified predicate devices. Testing and analyses included:
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
No clinical tests were conducted to demonstrate substantial equivalence.
Results of performance testing and analyses demonstrate that the ARTICUL/EZE Ceramic Heads perform as well as the predicate devices.
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.
DEPUY CERAMIC FEMORAL HEADS: K031803, ARTICUL/EZE FEMORAL HEADS: K980513
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.
ICONACY I-Hip K151307
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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.
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.
1
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:
- A severely painful and/or disabled joint from osteoarthritis, 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, arthrodesis, hemiarthroplasty, surface
replacement arthroplasty, or total hip replacement.
- 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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3
510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | Loughbeg, Ringaskiddy |
| Co. Cork Munster, IRELAND | |
| Establishment Registration | |
| Number | 3015516266 |
| Name of contact person | Paige Myers |
| E-Mail Address | pmyers1@its.jnj.com and |
| 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 |
| uncemented prosthesis | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3353 |
| Product Code(s) | LZO |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary Predicate Device: DEPUY CERAMIC FEMORAL HEADS: |
| K031803 | |
| Secondary Predicate Device: ARTICUL/EZE FEMORAL HEADS: | |
| K980513 | |
| Reference Device: ICONACY I-Hip K151307 | |
| Reason for 510(k) submission | The purpose of this 510K submission is to obtain market clearance for |
| ARTICUL/EZE Ceramic Heads | |
| Device description | The ARTICUL/EZE Ceramic Heads are a zirconia toughened alumina |
| 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 | |
| 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: |
- 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. |
| Performance Testing | The ARTICUL/EZE Ceramic Heads were tested to demonstrate the substantial
equivalence to the identified predicate devices. Testing and analyses included:
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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5
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE | |||||
|---|---|---|---|---|---|
| Characteristics | Subject Device: | ||||
| ARTICUL/EZE Ceramic | |||||
| Heads | Primary Predicate Device: | ||||
| DEPUY CERAMIC | |||||
| FEMORAL HEADS | |||||
| (K031803) | Secondary Predicate Device: | ||||
| ARTICUL/EZE COCR | |||||
| FEMORAL HEADS | |||||
| (K980513) | Reference Device: | ||||
| ICONACY I-Hip (K151307) | |||||
| Intended Use | Same as primary predicate | ||||
| device | Intended for use in total hip | ||||
| arthroplasty | Same as primary predicate | ||||
| device | Same as primary predicate | ||||
| device | |||||
| Indications for | |||||
| Use | Same as primary predicate | ||||
| device | 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. | Total hip replacement is
indicated in the following
conditions: - A severely painful and/or
disabled joint from
osteoarthritis, traumatic
arthritis, or rheumatoid arthritis - 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. | 1. A severely painful and/or
disabled hip joint as a result of
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
- Nonunions, correction of
functional deformity, and
trochanteric fractures of the
proximal femur with head
involvement that are
unmanageable using other
techniques. | |
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| | Cerasurf-w, a Zirconia-toughened
Alumina Ceramic (ZTA)
(ISO 6474-2:2019) | CeramTec BIOLOX® delta, a
Zirconia-toughened Alumina
Ceramic (ZTA)(ISO 6474-2:2019) | CoCrMo (ASTM F1537-11) | Ceramic heads: Cerasurf-p, a
Zirconia-toughened Alumina
Ceramic (ZTA)(ISO 6474-2:2019) |
|-------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Material | | | | |
| Outer Diameter
Sizes | Same as secondary predicate
device | 28mm, 32mm, 36mm | 22.225mm, 28mm, 32mm,
36mm, 40mm | 28mm, 32mm, 36mm |
| Taper | Same as primary predicate
device | 12/14 ARTICUL/EZE taper | Same as primary predicate
device | 12/14 taper |
| Offsets | Same as secondary predicate
device | 28mm: +1.5, +5, +8.5
32mm: +1, +5, +9
36mm: +1.5, +5, +8.5, +12 | 22.225mm: +4, +7
28mm: +1.5, +5, +8.5,
32mm: +1, +5, +9
36mm: -2, +1.5, +5, +8.5, +12
40mm: -2, +1.5, +5, +8.5, +12 | 28mm: -4, +0, +4
32mm: -4, +0, +4, +7
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)