(82 days)
Not Found
No
The summary describes a knee prosthesis and surgical instrumentation, focusing on mechanical and kinematic alignment techniques. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is a knee prosthesis, which is explicitly described as resurfacing articulating surfaces to address severe knee pain and disability, indicating its therapeutic purpose of treating a condition.
No
This device is described as a "semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones" and includes "surgical instrumentation that facilitate implantation of the above described implant components." Its intended use is for patients with severe knee pain and disability due to various conditions (e.g., rheumatoid arthritis, osteoarthritis) primarily for surgical intervention (resurfacing). It does not perform any diagnostic function.
No
The device description explicitly states it includes "surgical instrumentation" and describes physical components like "femoral rotation guide and anterior-posterior cutting blocks." This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Persona Personalized Knee System is a "semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones." It is an implantable device used in surgery.
- Intended Use: The intended use describes the conditions for which the knee prosthesis is indicated, all of which relate to severe knee pain and disability requiring surgical intervention and implantation of the device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, this device is a surgical implant and associated instrumentation, not an in vitro diagnostic device.
N/A
Intended Use / 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 kinematic 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 kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.
Porous coated components may be used cemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OIY, MBH
Device Description
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 Persona Personalized Knee System includes surgical instrumentation that facilitate implantation of the above described implant components.
The purpose of this submission is the introduction of an optional alternative surgical technique for distal femoral resection that enables for gap balancing and femoral external rotation, accomplished via the use of a new instrument platform including a femoral rotation guide and anterior-posterior cutting blocks. The resection of the proximal tibia is performed in accordance with the standard Persona Primary Knee Surgical Technique.
The new instruments do not change the intended use or fundamental scientific technology of the Persona Personalized Knee System components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions:
- Biocompatibility assessment
- Cadaveric design validation
- Design Verification Modular Brackets
Clinical Performance and Conclusions:
- Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
September 28, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" written in a clear, sans-serif font. The overall design is clean and professional, reflecting the organization's role in public health and safety.
Zimmer Switzerland Manufacturing GmbH Anne-Kathrin Born Regulatory Affairs Senior Specialist Sulzerallee 8 Winterthur, Zurich 8404 SWITZERLAND
Re: K212129/S001
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, OIY, MBH Dated: September 8, 2021 Received: September 10, 2021
Dear Anne-Kathrin Born:
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,
Ting Song, Ph.D., R.A.C. 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) K212129
Device Name
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 kinematic 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 kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.
Porous coated components may be used cemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
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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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is also in blue, matching the color of the circle and "Z" symbol. The overall design is clean and corporate, representing the company's brand identity.
K212129 page 1 of 2
510 (k) Summary
| Sponsor: | Zimmer Switzerland Manufacturing GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anne-Kathrin Born
Senior Specialist, Regulatory Affairs
Telephone: +41 79 518 26 17
Fax: +41 52 244 86 58 |
| Date: | September 28, 2021 |
| Trade Name: | Persona® Personalized Knee System |
| Common Name: | Knee Prostheses |
| Classification: | Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis (21CFR 888.3560) |
| | Knee joint patellofemorotibial metal/polymer porous-coated
uncemented prosthesis (21 CFR 888.3565) |
| Product Codes: | JWH, OIY, MBH |
| Predicate Device: | Zimmer Persona™ Knee System, manufactured by Zimmer Inc.,
K113369, cleared March 27, 2012 |
| Device Description: | 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 Persona
Personalized Knee System includes surgical instrumentation that
facilitate implantation of the above described implant components. |
| | The purpose of this submission is the introduction of an optional
alternative surgical technique for distal femoral resection that enables
for gap balancing and femoral external rotation, accomplished via the
use of a new instrument platform including a femoral rotation guide
and anterior-posterior cutting blocks. The resection of the proximal
tibia is performed in accordance with the standard Persona Primary
Knee Surgical Technique. |
| | The new instruments do not change the intended use or fundamental
scientific technology of the Persona Personalized Knee System
components. |
| Intended Use and 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. |
4
Image /page/4/Picture/0 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in gray. The text is in a sans-serif font and is aligned to the right of the circle.
K212129 page 2 of 2
| - 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 kinematic 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 kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension. | |
| Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, stem extension, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only. | |
| Comparison to Predicate Device: | The subject instruments do not change the intended use or the fundamental scientific technology of the existing instruments used with the Persona Personalized Knee System. |
| Performance Data (Nonclinical and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Biocompatibility assessmentCadaveric design validationDesign Verification Modular Brackets | |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for this device. | |
| Conclusion: | The subject devices have the same intended use and indications for use as the predicate devices. The subject devices use the similar operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using the similar materials and processes as the predicate devices. |
| Except for the modifications described in this submission the subject devices are identical to the predicate devices, and the performance data and analyses demonstrate that: | |
| any differences do not raise new questions of safety and effectiveness as established with performance testing; andthe subject devices are at least as safe and effective as the legally marketed predicate devices. |