(55 days)
Not Found
No
The summary describes a partial knee replacement system and surgical instrumentation, with no mention of AI or ML technology.
Yes.
The device is a partial knee replacement system, which aims to alleviate pain and disability in patients with various knee joint conditions, thus providing therapeutic benefit.
No
The device description clearly states that the Persona Partial Knee (PPK) system is a partial knee replacement system, consisting of implant components and surgical instrumentation for implantation. It is a therapy device, not a diagnostic one.
No
The device description explicitly lists hardware components (femoral, articular, and tibial components made of Co-Cr-Mo, VEHXPE, and Ti-6Al-4V alloys) and surgical instrumentation. It also describes physical modifications to the surgical technique involving new tibial cut guides and recutters.
Based on the provided text, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The Persona Partial Knee System is a partial knee replacement system, which is an implantable medical device used to surgically replace damaged parts of the knee joint.
- Intended Use: The intended use is to treat painful and/or disabling knee joints due to various conditions by surgically implanting the device.
The device is a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:
- Noninflammatory degenerative joint disease (NIDJ), e.g., osteoarthritis, avascular necrosis;
- traumatic arthritis;
- previous tibial condyle or plateau fractures with loss of anatomy or function;
- varus deformities; and
- revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged.
The Persona Partial Knee System is a single use implantation with bone cement.
Indications for combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ):
- Osteoarthritis, traumatic arthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
- The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).
- History of patellar dislocation or patella fracture.
- Dysplasia-induced degeneration.
These indications will be used for the combined medial and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions.
Combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ) implants are intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HSX
Device Description
The Persona Partial Knee (PPK) system is a partial knee replacement system for the medial compartment of the knee and is modular in design consisting of three implant components:
- Unicondylar Cobalt-Chromium-Molybdenum (Co-Cr-Mo) alloy Femoral components
- Unicondylar Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE) Articular surfaces
- Unicondylar Titanium (Ti-6Al-4V) alloy Tibial components
The Persona Partial Knee System includes surgical instrumentation that facilitate implantation of the above described implant components.
The purpose of this submission is to 1) introduce an alternate surgical technique for proximal tibial resection, accomplished via the introduction of new tibial cut guides and recutters; 2) introduce a new peg drill for preparation of tibial bone; all of which are intended to be used specifically with the Persona Partial Knee system and 3) reclassify the existing tibial cut guides, recutters and the peg drill used with various partial knee systems as Class II devices.
The new instruments do not change the intended use or fundamental scientific technology of the Persona Partial Knee System components.
The Persona Partial Knee System is intended for use in partial knee arthroplasty. Instrumentation is intended to facilitate implantation of the Persona Partial Knee implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, medial tibiofemoral compartment, patellofemoral joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Tests:
- Cut guide and recutter simulated use verification
- Tibial plateau strains evaluation
- Cadaveric design validation
- Functional relationship analyses
- Biocompatibility assessment
Clinical Tests:
- Clinical data was not deemed necessary to establish substantial equivalence between the subject and predicate devices.
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
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains 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.
March 17, 2020
Zimmer, Inc. Pankti Shah Regulatory Affairs Specialist 1800 W. Center Street Warsaw, IN 46580
Re: K200151
Trade/Device Name: Persona Partial Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: January 21, 2020 Received: January 22, 2020
Dear Pankti Shah:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
for Ting Song
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
2
Indications for Use
510(k) Number (if known) K200151
Device Name Persona Partial Knee System
Indications for Use (Describe) Indications for Persona Partial Knee System:
The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:
-
Noninflammatory degenerative joint disease (NIDJ), e.g., osteoarthritis, avascular necrosis;
-
traumatic arthritis;
-
previous tibial condyle or plateau fractures with loss of anatomy or function;
-
varus deformities; and
-
revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged.
The Persona Partial Knee System is a single use implantation with bone cement.
Indications for combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ):
-
Osteoarthritis, traumatic arthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
-
The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).
-
History of patellar dislocation or patella fracture.
-
Dysplasia-induced degeneration.
These indications will be used for the combined medial and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions.
Combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ) implants are intended for implantation with bone cement.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Persona Partial Knee System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708
Establishment Registration Number: 1822565 |
|-----------------|-----------------------------------------------------------------------------------------------------|
| Contact Person: | Pankti Shah
Regulatory Affairs Specialist
Telephone: 574-371-9830 |
| Date: | 21 January 2020 |
| Subject Device: | Trade Name: Persona® Partial Knee System
Common Name: Knee Prosthesis |
| | Classification Name:
HSX- Prosthesis, Knee, Femorotibial, Non- |
- HSX- Prosthesis, Knee, Femorotibial, Non-● Constrained, Cemented, Metal/Polymer (21 CFR 888.3520)
| Device | 510(k)
Number | Manufacturer |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|--------------|
| Persona Partial Knee System | K161592 | Biomet, Inc. |
| | | |
| | | |
| The Persona Partial Knee (PPK) system is a partial knee
replacement system for the medial compartment of the knee
and is modular in design consisting of three implant
components: | | |
| Unicondylar Cobalt-Chromium-Molybdenum (Co-Cr-
●
Mo) alloy Femoral components | | |
| Unicondylar Vivacit-E ® Vitamin-E Highly
●
Crosslinked Polyethylene (VEHXPE) Articular
surfaces | | |
| | | |
- Unicondylar Titanium (Ti-6Al-4V) alloy Tibial components
4
The Persona Partial Knee System includes surgical instrumentation that facilitate implantation of the above described implant components.
The purpose of this submission is to 1) introduce an alternate surgical technique for proximal tibial resection, accomplished via the introduction of new tibial cut guides and recutters; 2) introduce a new peg drill for preparation of tibial bone; all of which are intended to be used specifically with the Persona Partial Knee system and 3) reclassify the existing tibial cut guides, recutters and the peg drill used with various partial knee systems as Class II devices.
The new instruments do not change the intended use or fundamental scientific technology of the Persona Partial Knee System components.
The Persona Partial Knee System is intended for use in partial knee arthroplasty. Instrumentation is intended to facilitate implantation of the Persona Partial Knee implants.
Indications for Use for the Persona Partial Knee System are as follows:
The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:
- Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis;
- traumatic arthritis:
- previous tibial condyle or plateau fractures with loss of anatomy or function;
- varus deformities; and
- revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged.
Intended Use and Indications for Use:
5
The Persona Partial Knee System is a single use implant intended for implantation with bone cement.
Indications for combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ):
- Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
- -The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).
- -History of patellar dislocation or patella fracture.
- Dysplasia-induced degeneration. -
These indications will be used for the combined medial unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions.
Combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ) implants are intended for implantation with bone cement.
Summary of Technological Characteristics:
The subject instruments do not change the intended use or the fundamental scientific technology of the existing instruments.
- Intended Use: Identical to the predicate
- o System Indications for Use: Identical to the predicate
- . Materials: Similar to the predicate
- PPK Tibial Cut guides and Recutters: Stainless o Steel (17-4 PH SST), Titanium Nitride (TiN) Coating
- PPK Tibial Peg Drill: Stainless Steel (17-4 PH o SST)
- Design Features: Similar to the predicate
- The subject tibial cut guides and recutters have O modified pin hole location and an open landing to allow for a non-captured sagittal cut. These cut guides and recutters have a titanium nitride coating, to allow for visual differentiation from
6
the previously marketed tibial cut guides and recutters.
- The subject tibial peg drill is designed such that O it has 2mm reduced from the shaft of the drill tip. This peg drill shaft has three engraved grooves and has "PPK" etched to allow for visual differentiation from the previously marketed tibial peg drill.
- Sterilization & Packaging: Identical to the predicate 0
Summary of Performance Data (Nonclinical and/or Clinical)
● Non-Clinical Tests:
- Cut guide and recutter simulated use verification O
- Tibial plateau strains evaluation O
- Cadaveric design validation O
- O Functional relationship analyses
- Biocompatibility assessment O
. Clinical Tests:
- Clinical data was not deemed necessary to o establish substantial equivalence between the subject and predicate devices.
Substantial Equivalence Conclusion
The subject devices have the same intended use and indications for use as the predicate devices. The subject device has similar technological characteristics to the predicates, thus the non-clinical performance data and analyses demonstrate that:
- any differences do not raise new questions of safety 0 and effectiveness; and
- the proposed device is at least as safe and effective as o the legally marketed predicate devices.