Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Collagen disorders, and/or avascular necrosis of the femoral condyle.
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities.
The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

When a Personalized Alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Collagen disorders, and/or avascular necrosis of the femoral condyle.
Moderate valgus, varus, or flexion deformities.

The Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.

Porous coated components may be used cemented or uncemented (biological fixation), except for the Persona Osseo Ti Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMVPE and VEHXPE) patella components are indicated for cemented use only.

Device Description

The purpose of this submission is to add the Personalized Alignment surgical technique indication to the Persona Personalized Knee System

AI/ML Overview

The provided text is a 510(k) summary for the Zimmer® Persona® Personalized Knee System, which is a knee prosthesis. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving a device meets specific acceptance criteria for performance as one might expect for a digital health or AI device.

Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is largely not applicable in the context of this 510(k) submission.

Here's why and what can be extracted:

Acceptance Criteria & Reported Performance: This document does not describe specific performance-based acceptance criteria for the device itself (e.g., accuracy, sensitivity, specificity, or surgical outcome percentages). Instead, it relies on demonstrating that the new indication (Personalized Alignment surgical technique) is substantially equivalent in terms of safety and effectiveness to existing predicate devices.
Study That Proves the Device Meets Acceptance Criteria: No clinical study demonstrating performance against acceptance criteria in the traditional sense is described. The "performance data" section explicitly states "Non-Clinical Tests" and "Clinical Tests: None provided."
Algorithm/AI Context: The Persona™ Personalized Knee System is a physical medical device (knee prosthesis), not an AI-powered diagnostic or therapeutic software. Therefore, concepts like "test set," "training set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance" are not relevant to this type of device submission.

Summary of Extracted Information based on the provided text's context:

Since the provided text is for a physical medical device (knee prosthesis) seeking 510(k) clearance based on substantial equivalence, the questions regarding acceptance criteria, study design, sample sizes, ground truth, experts, and AI analysis are generally not applicable. The submission focuses on comparing the new use of the device to existing predicate devices.

What can be inferred or directly stated from the text:

Device Type: Zimmer® Persona® Personalized Knee System (Knee Prosthesis)
Purpose of Submission: To add the "Personalized Alignment surgical technique indication" to the existing Persona Personalized Knee System.
Basis for Clearance: Substantial Equivalence to predicate devices (K113369, K172524, K221479).
Rationale for Substantial Equivalence: Based on identical/similar characteristics:
- Intended Use: Identical
- Indications for Use: Similar (expanded with Personalized Alignment)
- Materials: Identical
- Design Features: Identical
- Sterilization: Identical
Non-Clinical Tests Performed:
- Persona® 0° Keel Tibial and Persona® PPS® Femur Design Validation - Device Comparison.
- Persona 0° Tibia Keel and Peg Perforation Personalized Alignment.
Clinical Tests: None provided.
Ground Truth: Not applicable in the context of this submission. The "ground truth" for a physical device is its physical properties and mechanical performance as demonstrated through non-clinical testing and comparison to predicates.

If this were a submission for an AI/digital health product, the information would be very different.

Summary

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March 8, 2023

Image /page/0/Picture/1 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zimmer, Inc. Gregory Foster Sr. Regulatory Affairs Specialist 1800 W. Center Street Warsaw. Indiana 46580

Re: K230321

Trade/Device Name: Persona™ Personalized Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OIY Dated: February 3, 2023 Received: February 6, 2023

Dear Gregory Foster:

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,

Ting Song -S

Ting Song, Ph.D. 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) K230321

Device Name

Zimmer® Persona® Personalized Knee System

Indications for Use (Describe)

When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Collagen disorders, and/or avascular necrosis of the femoral condyle.
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities.
The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

When a Personalized Alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Collagen disorders, and/or avascular necrosis of the femoral condyle.
Moderate valgus, varus, or flexion deformities.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708Establishment Registration Number: 1822565
Contact Person:	Gregory FosterSr. Regulatory SpecialistTelephone: (574) 371-0519Fax: (574) 377-3718Gregory.foster@zimmerbiomet.com
Date:	03-Feb-2023
Subject Device:	Trade Name: Persona® Personalized Knee System
	Common Name: Knee Prosthesis
Classification Name:	Classification Name:JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560) MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained Uncemented, Porous, Coated, Polymer/Metal/Polymer (21 CFR 888.3565) OIY- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (21 CFR 888.3560)

Predicate Device(s):

K113369	Zimmer®Persona™ KneeSystem	Zimmer, Inc.
K172524	Zimmer®Persona™ KneeSystem	Zimmer, Inc.
K221479	Zimmer®Persona™ KneeSystem	Zimmer, Inc.

Device Description:

The purpose of this submission is to add the Personalized Alignment surgical technique indication to the Persona Personalized Knee System

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Indications for Use:	When a mechanical alignment approach is utilized, this device isindicated for patients with severe knee pain and disability due to:— Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.— Collagen disorders, and/or avascular necrosis of the femoral condyle.— Post-traumatic loss of joint configuration, particularly when there ispatellofemoral erosion, dysfunction or prior patellectomy.— Moderate valgus, varus, or flexion deformities.— The salvage of previously failed surgical attempts or for a knee inwhich satisfactory stability in flexion cannot be obtained at the time ofsurgery.
	When a Personalized Alignment approach is utilized, this device isindicated for patients with severe knee pain and disability due to:— Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.— Collagen disorders, and/or avascular necrosis of the femoral condyle.— Moderate valgus, varus, or flexion deformities.
	The Personalized Alignment (PA) surgical technique may only be usedwith Persona cemented and uncemented CR femoral components,Persona CR, Ultra Congruent (UC), and Medial Congruent (MC)articular surface components, the Persona Cemented Stemmed tibialcomponents without a stem extension, and the Persona OsseoTi KeelTibia and Cemented Keel Tibia.
	Porous coated components may be used cemented or uncemented(biological fixation), except for the Persona OsseoTi Keel Tibia which isfor uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components areindicated for cemented use only.

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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: Identical to the predicate
o Design Features: Identical to the predicate
Sterilization: Identical to the predicate ●

Summary of Performance Data (Nonclinical and/or Clinical)

o Non-Clinical Tests:

Persona® 0° Keel Tibial and Persona® PPS® Femur Design O Validation - Device Comparison.
Persona 0° Tibia Keel and Peg Perforation Personalized O Alignment

Clinical Tests: ●

None provided o

Substantial Equivalence Conclusion

Based on the information contained within this submission, it is concluded that the Persona® Personalized Knee System are substantially equivalent to the identified predicate devices.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.