(176 days)
No
The 510(k) summary describes a ceramic hip implant component and its mechanical properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to treat various conditions of the hip joint, such as osteoarthritis, avascular necrosis, and fractures, which qualifies it as a therapeutic device.
No
The device description and intended use indicate that the Zimmer Biomet™ Select Ceramic Heads are prosthetic components for hip replacement surgery, not a device used to diagnose medical conditions.
No
The device description clearly states it is a modular ceramic head with adapter sleeves, intended for mating with femoral stems. This describes a physical implant, not software.
Based on the provided information, the Zimmer Biomet™ Select Ceramic Heads are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating various hip joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a modular ceramic head designed to be implanted in the body and mate with femoral stems. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue) or providing information for diagnosis.
- Performance Studies: The performance studies focus on mechanical properties, wear resistance, and MRI compatibility, which are relevant to the safety and function of an implantable device, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Zimmer Biomet™ Select Ceramic Heads do not fit this description.
N/A
Intended Use / Indications for Use
The Zimmer Biomet™ Select Ceranic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
When used with constrained acetabular liners, the Zimmer Biomet™ Select Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Product codes (comma separated list FDA assigned to the subject device)
LZO, KWY, KWZ
Device Description
The Zimmer Biomet™ Select™ Ceramic Heads are modular ceramic heads with a Type 1, 12/14 or 6 Degree adapter sleeve. They are offered in a variety of head diameters and neck configurations. They are intended for mating with a variety of Titanium Alloy and Cobalt-Chromium Alloy, as well as Stainless Steel, femoral stems equipped with tapered necks.
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
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)
Non-Clinical Tests:
- Static Compression
- Axial Fatigue and Post-Fatigue Compression
- Axial Pull-Off
- On-axis and Off-axis Impaction and Compression
- Magnetic Resonance Imaging (MRI) studies
- Resistance to Wear and Head Retention were considered
- Range of Motion
Clinical Tests:
- Clinical data were not deemed necessary for the subject device.
Key results: any differences do not raise new questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed 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.
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.
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 for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 26, 2018
Zimmer, Inc. Carol Vierling Regulatory Affairs Project Manager PO Box 708 Warsaw, Indiana 46581-0708
Re: K181761
Trade/Device Name: Zimmer Biomet Select 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, KWY, KWZ Dated: November 28, 2018 Received: November 30, 2018
Dear Carol Vierling:
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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/1/Picture/5 description: The image shows a digital signature. The signature is by Vesa Vuniqi-S. The date of the signature is 2018.12.26. The time of the signature is 16:20:28 -05'00'.
Mark N. Melkerson For: Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181761
Device Name Zimmer BiometTM Select Ceramic Heads
Indications for Use (Describe)
The Zimmer Biomet™ Select Ceranic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
When used with constrained acetabular liners, the Zimmer Biomet™ Select Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
| 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
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Zimmer Biomet™ Select™ Ceramic Heads 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708
Establishment Registration Number: 1822565 | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------|
| Contact Person: | Carol Vierling
Regulatory Affairs Project Manager
Telephone: (706-476-2938) | | |
| Date: | November 28, 2018 | | |
| Subject Device: | Trade Name: Zimmer Biomet™ Select™ Ceramic Heads
Common Name: Ceramic Femoral Head Prosthesis | | |
| | Classification Name:
• LZO— Hip joint/metal/ceramic/polymer
semiconstrained cemented or nonporous uncemented
prosthesis (21 CFR 888.3353)
• KWZ—Hip joint femoral (hemi-hip), metal/polymer
cemented or uncemented prosthesis (21 CFR 888.3390)
• KWZ—Hip joint metal/polymer constrained cemented
or uncemented prosthesis (21 CFR 888.3310) | | |
| Primary Predicate: | K141653 | Biolox® delta
Option Ceramic
Heads | Biomet, Inc. |
| Additional Predicate: | K073567 | BIOLOX® OPTION
Ceramic Femoral
Head System | Zimmer GmbH |
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K181761 Page 2 of 4
| Reference Devices: | K151307 | ICONACY™ I-Hip™ | ICONACY Orthopedic Implants, LLC |
|---|---|---|---|
| K960658 | Collarless Polished Hip Prosthesis | Zimmer, Inc. | |
| K032396 | RingLoc® 36mm Liners and Modular Femoral Heads | Biomet, Inc. |
Purpose and Device Description:
This traditional 510(k) premarket notification is being submitted to obtain clearance for the Zimmer Biomet™ Select™ Ceramic Heads. The heads are made from an alumina matrix composite. The adapter sleeve is made from Ti-6Al-4V Alloy.
The Zimmer Biomet™ Select™ Ceramic Heads are modular ceramic heads with a Type 1, 12/14 or 6 Degree adapter sleeve. They are offered in a variety of head diameters and neck configurations. They are intended for mating with a variety of Titanium Alloy and Cobalt-Chromium Alloy, as well as Stainless Steel, femoral stems equipped with tapered necks.
Intended Use and Indications for Use:
The Zimmer Biomet™ Select Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of 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, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
When used with constrained acetabular liners, the Zimmer Biomet™ Select Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity,
5
neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to the predicate ●
- Indications for Use: Similar to the predicate ●
- Materials: Similar to the predicate. Both ceramic . heads meet ISO 6472-2, Implants for Surgery-Ceramic Materials. Identical to the reference device, the ICONACY™ I-Hip™ Ceramic Heads, and similar manufacturing process
- Design Features: Both the subject and predicate ● devices mate with a variety of femoral stems equipped with tapered necks. The variety of head diameters and neck configurations is similar although the subject device is available in a larger range of tapers and offsets.
- Sterilization: Identical
Summary of Performance Data (Nonclinical and/or Clinical)
● Non-Clinical Tests:
- Static Compression O
- Axial Fatigue and Post-Fatigue Compression O
- Axial Pull-Off O
- On-axis and Off-axis Impaction and Compression O
- Magnetic Resonance Imaging (MRI) studies O
- Resistance to Wear and Head Retention were O considered
- Range of Motion O
- Clinical Tests:
- Clinical data were not deemed necessary for the O subject device.
Substantial Equivalence Conclusion
The subject device has the same intended use and similar indication for use as the predicate devices. The subject device is made of a similar material as the primary predicate device. In addition, the subject device has
6
similar technological characteristics to the predicate and reference devices. The performance data and analyses demonstrate that:
- o any differences do not raise new questions of safety and effectiveness; and
- the proposed device is at least as safe and o effective as the legally marketed predicate devices.