Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)

K253189 · Zimmer, Inc. · MBH · Mar 9, 2026 · Orthopedic

Device Facts

• Record ID: K253189
• Device Name: Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
• Applicant: Zimmer, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Mar 9, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. 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 OsseoTi Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

Device Story

Persona Personalized Knee System is a semiconstrained modular knee prosthesis; resurfaces articulating surfaces of femoral, tibial, and patellar bones. Femoral components match patient anatomy; provided sterile and single-use. Submission adds new Porous Plasma Spray (PPS) coating supplier. Used in total knee arthroplasty by orthopedic surgeons in clinical settings. Components articulate against tibial and patellar components to restore joint function and reduce pain.

Clinical Evidence

No clinical data. Bench testing included fatigue testing (cantilever loading and three-point bend), design verification, structural/microstructural characterization of PPS coating, and assessment of constraint, range of motion, and contact area/stress.

Technological Characteristics

Semiconstrained modular knee prosthesis; femoral components feature Porous Plasma Spray (PPS) coating for biological fixation. Materials include CoCr. Components are sterile and single-use. Identical articulating geometry to predicate.

Indications for Use

Indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of femoral condyle, post-traumatic joint loss, or moderate valgus/varus/flexion deformities. Includes salvage of failed surgeries or unstable knees.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• Persona the Personalized Knee System: Persona Porous Plasma Spray (PPS) Femurs (K221479)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 9, 2026

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

Re: K253189
Trade/Device Name: Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
Regulation Number: 21 CFR 888.3565
Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis
Regulatory Class: Class II
Product Code: MBH, JWH, OIY
Dated: February 9, 2026
Received: February 9, 2026

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253189 - Gregory Foster
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the Medical Device File (21 CFR 820.181).

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K253189 - Gregory Foster
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Peter G.
Allen -S

Digitally signed by Peter
G. Allen -S
Date: 2026.03.09
16:22:42 -04'00'

For Lixin Liu, 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 | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K253189 | ? |
| Please provide the device trade name(s). | | ? |
| Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | | |
| Please provide your Indications for Use below. | | ? |
| 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. | | |
| 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 OsseoTi Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and all-
polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only. | | |
| Please select the types of uses (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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K253189 Page 1 of 2

| 510(k) #: K253189 | 510(k) Summary | Prepared on: 2026-02-09 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Zimmer, Inc. | |
| Applicant Address | 1800 W. Center Street Warsaw IN 46580 United States | |
| Applicant Contact Telephone | [phone] | |
| Applicant Contact | Dr. Gregory Foster | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | |
| Common Name | Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis | |
| Classification Name | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | |
| Regulation Number | 888.3565 | |
| Product Code(s) | MBH, JWH, OIY | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K221479 | Persona the Personalized Knee System: Persona Porous Plasma Spray (PPS) Femurs | MBH |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The purpose of this submission is to add a new Porous Plasma Spray (PPS) Coating Supplier for the Persona PPS Femurs of the Persona Personalized Knee System. The addition of this new supplier does not change the intended use, design, or fundamental scientific technology of the device.
The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones. The femoral components articulate against an articular surface of the tibial component, as well as, a patellar component, as part of a total knee system. The femoral components come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| 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. | | |

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K253189 Page 2 of 2

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 OsseoTi Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

**Indications for Use Comparison** 21 CFR 807.92(a)(5)

The indications are identical between the predicate and the subject device.

**Technological Comparison** 21 CFR 807.92(a)(6)

The subject and predicate devices are both porous plasma sprayed (PPS) femoral components. The articulating geometry identical between the predicate and the subject devices. Both devices have the same technological characteristics.

**Non-Clinical and/or Clinical Tests Summary & Conclusions** 21 CFR 807.92(b)

- Persona PPS CoCr Posterior Condyle Fatigue – Cantilever Loading
- Persona PPS Posterior Condyle Fatigue – Three Point Bend
- Evaluation of Persona PPS CoCr Product Design Verification Requirements
- Evaluation of Product Requirements for the Persona PPS Femurs PPS coating
- Visual, Structural and Microstructural Characterization of the Porous Plasma Spray (PPS) Coating
- Assessment of the Constraint, Range of Motion, and Contact Area/Stress of the Persona PPS Femurs

Clinical Testing Not Applicable

The proposed device has the same intended use as the predicate(s). The proposed device has the same technological characteristics to the predicate(s), and the information provided herein demonstrates 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 device(s).