Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
Revision procedures where other treatment or devices have failed

Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented use.

Indications for G7® Vivacit-E® Freedom® Constrained Liner:

The G7® Vivacit-E® Freedom® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of distory of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

Device Description

The G7 Acetabular System currently offers a constrained Vitamin E infused highly crosslinked ultra high molecular weight polyethylene (UHMWPE) liner, branded E1 polyethylene, with a preassembled titanium alloy constraining ring. The constrained liner is designed for use in primary or revision total hip arthroplasty (THA) patients that are at a greater risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Zimmer Biomet has designed and developed a new constrained liner for use within the G7 Acetabular System, the G7® Vivacit-E® Freedom® Constrained Liner. The purpose of this submission is to obtain clearance for this new constrained liner.

AI/ML Overview

The provided text describes the 510(k) submission for the G7® Vivacit-E® Freedom® Constrained Liner, a medical device for total hip arthroplasty. The document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of a diagnostic AI/ML device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for medical device approval in the United States. This involves comparing the new device's characteristics and performance to a legally marketed predicate device.

Therefore, I cannot extract the requested information from the provided text for the following reasons:

No acceptance criteria for an AI/ML device are described. The document pertains to a physical orthopedic implant, not a diagnostic AI/ML software. Acceptance criteria for mechanical implant devices typically involve benchmarks for physical properties, wear, and mechanical strength, which are mentioned in the "Summary of Performance Data," but these are not the type of diagnostic performance metrics expected for an AI/ML device.
No study proving diagnostic performance is detailed. The studies listed are engineering performance tests for a physical implant (e.g., insertion energy, torque out, wear testing, fatigue testing, range of motion), not studies to assess diagnostic accuracy, sensitivity, or specificity of an AI/ML algorithm.
No information on ground truth, expert consensus, or training/test sets for an AI/ML model is present. These concepts are not applicable to the type of device described in the document.

In summary, the provided document does not align with the request to describe acceptance criteria and a study for an AI/ML diagnostic device. It describes a traditional medical device (a hip implant component) and its substantial equivalence submission to the FDA.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

April 28, 2022

Zimmer, Inc. Adam Haas Regulatory Affairs Senior Specialist 1800 W. Center Street Warsaw, Indiana 46580

Re: K212512

Trade/Device Name: G7® Vivacit-E® Freedom® Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip Joint Metal/Polymer Constrained Or Uncemented Prosthesis Regulatory Class: Class II Product Code: PBI, JDI, KWZ, LPH, LZO, OOG, OQH, OQI Dated: April 1, 2022 Received: April 1, 2022

Dear Adam Haas:

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

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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,

Limin Sun, Ph.D. 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

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Indications for Use

510(k) Number (if known) K212512

Device Name

G7® Vivacit-E® Freedom® Constrained Liner

Indications for Use (Describe)

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head

involvement, unmanageable by other techniques

Revision procedures where other treatment or devices have failed

Indications for G7® Vivacit-E® Freedom® Constrained Liner:

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

Sponsor:	Zimmer, Inc.1800 W. Center StreetWarsaw, IN 46580Establishment Registration Number: 1822565
Contact Person:	Adam HaasRegulatory Affairs Senior SpecialistTelephone: (908-361-7475)Adam.Haas@zimmerbiomet.com
Date:	April 27, 2022
Subject Device:	Trade Name: G7 ® Vivacit-E ® Freedom ® ConstrainedLiner
	Primary Classification Name:
	• PBI - Prosthesis, Hip, Constrained, Cemented orUncemented, Metal/Polymer, + Additive (21 CFR888.3310 - Hip joint metal/polymer constrainedcemented or uncemented prosthesis)
	Additional Classification Names:
	• JDI - Prosthesis, Hip, Semi-Constrained,Metal/Polymer, Cemented (21 CFR 888.3350 – Hipjoint metal/polymer semi-constrained cementedprosthesis)• KWZ - Prosthesis, Hip, Constrained, Cemented OrUncemented, Metal/Polymer (21 CFR 888.3310 – Hipjoint metal/polymer constrained cemented oruncemented prosthesis)• LPH - Prosthesis, Hip, Semi-Constrained,Metal/Polymer, Porous Uncemented (21 CFR 888.3358– Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis)• LZO - Prosthesis, Hip, Semi-Constrained,Metal/Ceramic/Polymer, Cemented Or Non-Porous,Uncemented (21 CFR 888.3353 – Hip jointmetal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis)

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· OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented (21 CFR 888.3358 - Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis)
· OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented (21 CFR 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis)
· OOI Hip. Semi-Constrained. Cemented. Metal/Ceramic/Polymer + Additive, Porous Uncemented (21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis)

510(k) Number	Device Name	Applicant
K121874 (primary)	G7 E1® Freedom	Biomet
and K142882	Constrained Liner	Orthopedics

Reference Predicate:

Predicate Device(s):

510(k) Number	Device Name	Applicant
K071718	Trilogy LongevityConstrained Liner	Zimmer, Inc.

Device Description:

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Indications for Use:

1 ) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head

involvement, unmanageable by other techniques 5) Revision procedures where other treatment or devices have failed

Indications for G7® Vivacit-E® Freedom® Constrained Liner:

The G7® Vivacit-E® Freedom® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

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

Intended Use: Same as the predicate device.
Indications for Use: Same as the predicate device. ●
Variants/Sizes: Same as the predicate device.
Design Features: Similar to the predicate device
. Material: The constraining ring and plug materials are same as the predicate device. The polyethylene materials used for the subject and the predicate devices are both Vitamin E infused highly crosslinked ultra high molecular weight polyethylenes. The two polyethylene materials use the same resin (GUR1020) but have different concentrations of Vitamin E and different manufacturing processes.
Sterility: Same as the predicate device. ●
Shelf Life: Same as the predicate device.

Summary of Technological Characteristics:

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Summary of Performance Data (Nonclinical and/or Clinical):

Following performance testing/evaluation were performed for the subject liner and are included in this 510(k) submission -

Minimum Dynamic Insertion Energy Required to . Seat G7 ® Vivacit-E ® Freedom ® Constrained Liner
G7® Vivacit-E® Freedom® Constrained Liner Torque Out Evaluation, Freedom Femoral Head Push-in and Pull-out forces from G7 ® Vivacit-E ® Freedom® Constrained Liner
Freedom Femoral Head Lever Out from G7 ® Vivacit-E® Freedom® Constrained Liner
Disassembly of the G7 ® Vivacit-E ® Freedom ® ● Constrained Liner Construct via Lever-Out
Disassembly of the 36mm G7 ® Vivacit-E ® . Freedom® ® Constrained Liner Construct via Lever-Out
In-Vitro Wear Testing of the G7 ® Vivacit-E ® ● Freedom® Constrained Liner
Constraining Ring Disassembly from the G7 ® . Vivacit-E® Freedom® Constrained Liner
Evaluation of G7 ® Vivacit-E ® Freedom® Constrained Liner in the Magnetic Resonance (MR) Imaging Environment
Anatomic Fatigue Testing of G7 ® Vivacit-E ® . Freedom® Constrained Liner
Rim Impingement Testing of G7 ® Vivacit-E ® ● Freedom® Constrained Liner
G7® Vivacit-E® Freedom® Constrained Liner ● Range of Motion
G7® Vivacit-E® Freedom® Constrained Liner . Lever-Out Test
In-Vitro Wear Testing of the G7 ® Vivacit-E ® Freedom® Constrained Liners in the Presence of Abrasive Particles

Substantial Equivalence Conclusion:

The intended use, indications for use, variants, sizes, materials (for the constraining ring and the plug). sterilization method, and shelf life of the subject liner are same as that of the predicate device. There are differences in the design features and material between the subject liner and the predicate device. However, these differences do not

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raise new questions of safety and/or effectiveness. The performance testing/evaluation and the biological safety risk assessment included in this 510(k) submission demonstrates that the subject liner is at least as safe and effective as the predicate device. Therefore, it is concluded that the G7® Vivacit-E® Freedom ® Constrained Liner is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”