← Product Code [MBH](/productcode/MBH) · K251840 # Zimmer® Persona® Personalized Knee System (K251840) _Zimmer, Inc. · MBH · May 28, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K251840 ## Device Facts - **Applicant:** Zimmer, Inc. - **Product Code:** [MBH](/productcode/MBH.md) - **Decision Date:** May 28, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3565 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for 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 AlignmentTM* 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. *Check for country clearances of the Persona Personalized Alignment surgical technique; not licensed in the European Union ## Device Story Total knee system for resurfacing articulating surfaces of femur, tibia, and patella; femoral components articulate against articular surfaces to accommodate high flexion up to 155°. Used in total knee replacement surgery by orthopedic surgeons in clinical settings. System includes femoral components, articular surfaces, tibial baseplates, and optional patellar components. Subject of this submission is the addition of an alternative porous plasma spray (PPS) coating vendor and updated MR conditional labeling. Output is a restored joint surface; clinical decision-making relies on surgeon assessment of patient need and alignment approach (mechanical vs. personalized). Benefits include pain relief and improved joint function. ## Clinical Evidence No clinical data. Substantial equivalence supported by non-clinical bench testing, including posterior condyle fatigue testing, porous plasma spray coating product requirements/design verification, biocompatibility, and expanded MRI compatibility evaluation. ## Technological Characteristics Total knee prosthesis; metal/polymer construction. Features porous plasma spray (PPS) coating for biological fixation. Components include femoral, tibial, and patellar elements. Sterilization and materials are identical to predicate K221479. MR conditional labeling updated. ## Regulatory 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® Personalized Knee System ([K221479](/device/K221479.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION May 28, 2026 Zimmer Inc. Dora Hu Senior Regulatory Affairs Specialist 1800 W. Center Street Warsaw, Indiana 46580 Re: K251840 Trade/Device Name: Zimmer® Persona® Personalized Knee System 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: May 1, 2026 Received: May 1, 2026 Dear Dora Hu: 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 {1} K251840 - Dora Hu Page 2 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), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (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 ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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- {2} K251840 - Dora Hu Page 3 assistance/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, LIXIN LIU -S 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 {3} Zimmer® Persona® Personalized Knee System Page 10 of 43 | 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. | K251840 | ? | | Please provide the device trade name(s). | | ? | | Zimmer® Persona® Personalized Knee System | | | | 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 AlignmentTM* 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. *Check for country clearances of the Persona Personalized Alignment surgical technique; not licensed in the European Union | | | | 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) | ? | {4} K251840 Page 1 of 2 | 510(k) #: K251840 | 510(k) Summary | Prepared on: 2026-05-28 | | --- | --- | --- | | 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 | +86 18892625295 | | | Applicant Contact | Ms. Dora Hu | | | Applicant Contact Email | Dora.Hu@zimmerbiomet.com | | | Device Name | | 21 CFR 807.92(a)(2) | | Device Trade Name | Zimmer® Persona® Personalized Knee System | | | Common Name | Total Knee System | | | Classification Name | Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis | | | 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® Personalized Knee System | JWH, MBH, | | Device Description Summary | | 21 CFR 807.92(a)(4) | | The purpose of this submission is to add an alternative Porous Plasma Spray coating vendor DOT America and update MR conditional labeling for the subject Persona® Personalized Knee System components: Persona Porous Plasma Spray (PPS) Femoral Components. The Persona Knee System resurfaces the articulating surfaces of the femur, tibia, and patella bones. The femoral components are used in combination with the existing Persona articular surfaces (required), an existing Persona tibial baseplate (required), and an optional, existing, Persona patellar component in total knee replacement surgery. The Persona femoral components articulate against the articular surfaces with or without an intact PCL, depending on configuration and patient need. They have highly polished condyles to minimize wear with the mating articular surfaces. They are able to safely accommodate high flexion of up to 155°, which is dependent upon the selected type of articular surface and femoral component. Conformity is achieved through the interaction of the femoral condyles with the articular surface. The femoral components are designed to articulate against a resurfaced or a non-resurfaced patella. | | | | 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. When a Personalized AlignmentTM® approach is utilized, this device is indicated for patients with severe knee pain and disability due to: | | | {5} K251840 Page 2 of 2 - 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. *Check for country clearances of the Persona Personalized Alignment surgical technique; not licensed in the European Union **Indications for Use Comparison** 21 CFR 807.92(a)(5) The subject device has the same intended use as the predicate devices and the same indications for use as the predicate devices. **Technological Comparison** 21 CFR 807.92(a)(6) The intended use, materials, design, packaging and sterilization method of the Persona the Personalized Knee System are unchanged since last 510(k) clearance (K221479). The proposed change is to add an alternate vendor to perform the porous plasma spray coating process to the Persona Porous Plasma Spray (PPS) femoral components. The PPS coating, supplied by this and the predicate's vendor meets the specifications for the design of the subject device. The proposed device has similar technological characteristics to the predicate, and the information provided herein demonstrates that: - any differences do not raise different questions of safety and effectiveness; and - the proposed device is at least as safe and effective as the legally marketed predicate device. **Non-Clinical and/or Clinical Tests Summary & Conclusions** 21 CFR 807.92(b) **Non-Clinical Tests:** - Posterior Condyle Fatigue Testing - Porous Plasma Spray Coating Product Requirements - Porous Plasma Spray Coating Product Design Verification Requirements - Biocompatibility - Expanded MRI Compatibility Evaluation for the Persona Primary Knee System **Clinical Tests:** No clinical testing was required to support substantial equivalence. **Conclusion:** Non-clinical testing demonstrated that the subject devices are substantially equivalent to the predicate devices. --- **Source:** [https://fda.innolitics.com/device/K251840](https://fda.innolitics.com/device/K251840) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com