• The Zimmer Biomet 12/14 CoCr Femoral Heads are intended for use in total and hemi arthroplasty* in primary and revision patients. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.

Hemi-Arthroplasty indication is for use with Bipolar Systems only.
• The Zimmer Biomet 12/14 CoCr Freedom® 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. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.

Device Description

This traditional 510(k) premarket notification is being submitted to obtain clearance for the Zimmer Biomet 12/14 CoCr Femoral Head and Freedom® Heads. The heads are made from Freedom® Heads cobalt-chromiummolybdenum alloy (CoCrMo) to ISO 5832-12:2007 and ASTM F1537-11.

AI/ML Overview

This document describes the 510(k) premarket notification for the Zimmer Biomet 12/14 CoCr Femoral Head and Freedom® Heads. It outlines the device's characteristics, intended use, indications for use, and a summary of performance data to support its substantial equivalence to predicate devices.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not present explicit acceptance criteria in a formal table format with numerical targets that the device performance must meet. Instead, the "Substantial Equivalence Conclusion" section functions as a high-level summary of how the device meets the criteria for 510(k) clearance, which is demonstrating substantial equivalence to legally marketed predicate devices.

Acceptance Criteria (Implied by 510(k) Requirements):

Criteria Category	Implied Acceptance	Reported Device Performance
Intended Use	Must be equivalent to predicate(s).	"Equivalent to predicate(s)."
Indications for Use	Must be identical to predicate(s).	"Identical to predicate(s)."
Materials	Must be identical or equivalent to predicate(s), posing no new safety or effectiveness concerns.	"Identical to predicate(s)." Specifically, "cobalt-chromium-molybdenum alloy (CoCrMo) to ISO 5832-12:2007 and ASTM F1537-11," which is the same as the primary predicate.
Design Features	Must be equivalent to predicate(s), or any differences must not raise new questions of safety and effectiveness. This often involves demonstrating comparable functional performance and safety.	"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 equivalent although the subject device is available in a larger range of sizes." The implication is that larger size range does not pose new safety/effectiveness issues.
Sterilization	Must be identical or equivalent to predicate(s), ensuring comparable sterility assurance levels.	"Identical to predicate."
Performance Data (Non-Clinical)	Must demonstrate that the device performs as safely and effectively as the predicate device(s) and that any differences do not raise new questions of safety and effectiveness. This typically involves specific mechanical and material testing relevant to the device's function.	Summarized as: "Pull Off Testing," "Accelerated Corrosion Fatigue," "Head Fatigue," and "Resistance to Wear and Head Retention were considered." The conclusion states these analyses demonstrate that "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."
Clinical Tests	For this type of device and submission, often not required if substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.	"N/A" (Not Applicable)

2. Sample sizes used for the test set and the data provenance

The document does not specify sample sizes for the non-clinical tests (e.g., how many heads were subjected to pull-off testing). It only lists the types of non-clinical tests performed.

Regarding data provenance:

Country of Origin: The manufacturer is listed as Zimmer, Inc., Warsaw, IN, USA, with a contact person in the UK (Zimmer Biomet UK, Bridgend). The specific location where the non-clinical tests were conducted is not detailed.
Retrospective or Prospective: The non-clinical tests described are by nature prospective tests performed specifically for this submission to demonstrate substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device is a mechanical implant (femoral head for hip arthroplasty), and its performance is evaluated through engineering and material science testing (non-clinical tests), not through analysis of medical images or patient data that would require expert human interpretation and "ground truth" establishment in the way an AI diagnostic device would.

4. Adjudication method for the test set

This is not applicable as the study involves non-clinical mechanical and material testing, not human-read test sets requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a hip implant component, not an AI-assisted diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be established by the engineering standards and test methodologies (e.g., ISO, ASTM standards, internal validated test protocols) and the resulting objective measurements (e.g., force, cycles to failure, corrosion rates). There isn't a "ground truth" in the sense of expert consensus, pathology, or outcomes data, as these tests are simulating mechanical and material performance rather than diagnosing a condition.

8. The sample size for the training set

This is not applicable. The device is a mechanical implant. There is no concept of a "training set" for an algorithm in this context. The manufacturing process and materials used are based on established engineering principles and prior validated designs.

9. How the ground truth for the training set was established

This is not applicable. As there is no training set for an algorithm, there is no ground truth to be established in that context.

Summary

{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.

November 5, 2019

Zimmer, Inc. % Dean Heit Global Regulatory Affairs Project Manager ZimmerBiomet Waterton Ind Estate Bridgend, CF31 3XA Gb

Re: K183457

Trade/Device Name: Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head 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, OQG, KWY, KWZ Dated: October 4, 2019 Received: October 7, 2019

Dear Dean Heit:

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/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 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,

FOR Vesa Vuniqi Acting 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K183457

Device Name

Zimmer Biomet 12/14 CoCr Femoral Heads and Freedom® Heads

Indications for Use (Describe)

Hemi-Arthroplasty indication is for use with Bipolar Systems only.

• The Zimmer Biomet 12/14 CoCr Freedom® 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. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 12/14 CoCr Femoral Head and Freedom® Head 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:	Dean HeitGlobal Regulatory Affairs Project ManagerZimmer Biomet UK.Waterton Industrial EstateBridgendUKCF31 3XAPhone: +44 (0) 1656 678359Mobile: +44 (0) 7429075094
Date:	12th December 2018
Subject Device:	Trade Name: Zimmer Biomet 12/14 CoCr FemoralHead and Freedom® Head
	Common Name: Zimmer Biomet 12/14 CoCr FemoralHead and Freedom® Head
	Classification Name: Zimmer Biomet 12/14 CoCrFemoral Head.
	LPH- prosthesis, hip, semi-constrained,metal/polymer, porous uncemented (21 CFR888.3358)
	OQG - hip prosthesis, semi-constrained, cemented,metal/polymer, + additive, porous, uncemented (21CFR 888.3358)
	KWY - Hip joint femoral (hemi-hip)metal/polymer cemented or uncemented prosthesis(21 CFR 888.3390)
	Classification Name: Zimmer Biomet 12/14 CoCrFreedom® Head.

{4}------------------------------------------------

• KWZ - Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310)
Primary Predicate Device(s):	K953337 –	Beta Hip ProsthesisZimmer Inc.
	K142882	G7 Freedom® And Offset Liners,Freedom® Head, Size 32.Biomet Inc.
Additional Predicates:	K121874 –	G7 Acetabular System.Biomet Manufacturing Corp.
Purpose and Device Description:	This traditional 510(k) premarket notification is being

submitted to obtain clearance for the Zimmer Biomet 12/14 CoCr Femoral Head and Freedom® Heads. The heads are made from Freedom® Heads cobalt-chromiummolybdenum alloy (CoCrMo) to ISO 5832-12:2007 and ASTM F1537-11.

Intended Use and Indications for Use:

The Zimmer Biomet 12/14 CoCr Femoral Heads are intended for use in total and hemi arthroplasty* in primary and revision patients. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.

Hemi-Arthroplasty indication is for use with Bipolar Systems only.

The Zimmer Biomet 12/14 CoCr Freedom® 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. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.

{5}------------------------------------------------

Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: Equivalent to predicate(s).
Indications for Use: Identical to predicate(s). ●
Materials: Identical to predicate(s).
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 equivalent although the subject device is available in a larger range of sizes.
Sterilization: Identical to predicate. 0

Summary of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Tests: ●

Pull Off Testing. O
Accelerated Corrosion Fatigue. O
Head Fatigue. O
Resistance to Wear and Head Retention were O considered.
Clinical Tests: ●
- o N/A

Substantial Equivalence Conclusion

The subject device has the same intended use and equivalent indication for use as the predicate devices. The subject device is made of the identical material using a equivalent manufacturing process as the primary predicate device. In addition, the subject device has equivalent 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

§ 888.3358 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.