The Zimmer Biomet™ 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™ 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.

Device Description

This traditional 510(k) premarket notification is being submitted to obtain clearance for the Zimmer Biomet™ Ceramic Heads. The heads are made from an alumina matrix composite. The Zimmer Biomet Ceramic Heads are supplied with a 12/14 bore or Type 1 bore and 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 femoral stems equipped with tapered necks.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) premarket notification for Zimmer Biomet Ceramic Heads, which details the device's classification, indications for use, and a summary of its technological characteristics and non-clinical and clinical tests. However, it does not specify acceptance criteria for performance or a study's results against those criteria.

Summary

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April 2, 2019

Zimmer, Inc Carol Vierling Regulatory Affairs Project Manager P.O Box 708 Warsaw, Indiana 46581-0708

Re: K181171

Trade/Device Name: Zimmer Biomet 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: February 28, 2019 Received: March 4, 2019

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

Daniel S. Ramsey -S 2019.04.02 16:43:05 -04'00'

FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181171

Device Name Zimmer Biomet™ Ceramic Heads

Indications for Use (Describe)

When used with constrained acetabular liners, the Zimmer Biomet™ 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 patients at 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™ 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 708Warsaw, IN 46581-0708Establishment Registration Number: 1822565
Contact Person:	Carol VierlingRegulatory Affairs Project ManagerTelephone: (706-476-2938)
Date:	March 27, 2019
Subject Device:	Trade Name: Zimmer Biomet™ Ceramic HeadsCommon Name: Ceramic Femoral Head Prosthesis
Classification Name:	• KWY—Hip joint femoral (hemi-hip), metal/polymercemented or uncemented prosthesis (21 CFR 888.3390)• KWZ—Hip joint metal/polymer constrained cementedor uncemented prosthesis (21 CFR 888.3310)• LZO— Hip joint/metal/ceramic/polymersemiconstrained cemented or nonporous uncementedprosthesis (21 CFR 888.3353)
Primary Predicate:	K151307	ICONACY™I-Hip™	ICONACYOrthopedicImplants, LLC
Additional Predicates:	K071535	BIOLOX® deltaCeramic FemoralHead	Zimmer, Inc.
	K131684	BIOLOX® deltaCeramic Heads	Biomet UK Ltd.

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Reference Device:	K141653	BIOLOX® delta Option Ceramic Heads	Biomet UK Ltd.
Purpose and Device Description:	This traditional 510(k) premarket notification is being submitted to obtain clearance for the Zimmer Biomet™ Ceramic Heads. The heads are made from an alumina matrix composite.The Zimmer Biomet Ceramic Heads are supplied with a 12/14 bore or Type 1 bore and 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 femoral stems equipped with tapered necks.
Intended Use and Indications for Use:	The Zimmer Biomet™ 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™ 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.
Summary of Technological Characteristics:	The rationale for substantial equivalence is based on consideration of the following characteristics:Intended Use: Identical to the predicate●

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Indications for Use: Similar to the predicate
Materials: Identical to the predicate
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 sizes.
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
O Resistance to Wear and Head Retention were considered.
Range of Motion O

● Clinical Tests:

Clinical data was 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 the identical material using a similar manufacturing process as the primary predicate device. In addition, the subject device has similar technological characteristics to the predicates and reference device. The performance data and analyses demonstrate that:

any differences do not raise new questions of O safety and effectiveness; and
the proposed device is at least as safe and O effective as the legally marketed predicate devices.

Regulation Number and Section

§ 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.