(147 days)
No
The document describes a mechanical knee implant system and its components. There is no mention of software, algorithms, image processing, AI, or ML. The performance studies are based on mechanical testing and engineering analysis, not data-driven AI/ML performance metrics.
Yes.
The device is a partial knee replacement system intended for patients with painful and/or disabling knee joints due to various conditions like osteoarthritis and traumatic arthritis, which are treated by replacing the affected joint components.
No
The Persona Partial Knee System is a partial knee replacement intended for implantation to treat painful and/or disabling knee joints due to various degenerative and traumatic conditions, as well as for revision surgeries. It is a therapy device that replaces a portion of the knee joint, not a device used to identify or analyze a medical condition.
No
The device description clearly states it is a partial knee replacement system consisting of physical components made of metal alloys and polyethylene.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a portion of the knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a knee replacement system (femoral component, tibial tray, articular surface). These are physical implants, not reagents or instruments used to examine specimens from the human body.
- Performance Studies: The performance studies focus on mechanical properties and compatibility of the implant, not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device is implanted into the body to restore function.
N/A
Intended Use / Indications for Use
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 (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 Systemknee surgeries providing that the tibial plate locking mechanism is not compromised 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 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.
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 for the medial compartment of the knee and is modular in design consisting of three components: a unicondylar cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, a unicondylar titanium (Ti-6Al-4V) alloy tibial tray, and a unicondylar articular surface manufactured using the previously cleared Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE).
The Persona Partial Knee System is compatible with the following devices:
- Zimmer Patellofemoral Joint Prosthesis (K070695)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
medial tibiofemoral compartment of the 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)
Results from mechanical tests and engineering analyses demonstrate the proposed PPK components are substantially equivalent to the predicate devices. No animal or clinical testing was required to support substantial equivalence. A description of the non-clinical tests and analyses performed are listed below.
- . Femoral Component
- o Cantilever fatigue per internal test method
- 3-Point Bending Fatigue per internal test method O
- Articular Surfaces
- Contact area per ASTM F2083 O
- Constraint per ASTM F2083 and ASTM F1223 O
- O Posterior Crush and Lift Off per internal test method
- Wear per engineering analysis O
- O Static locking mechanism strength per internal test method
- Tibial Components
- 3-Point bending fatigue per internal test method O
- System Compatibility
- Patellar component and PFJ compatibility per engineering analysis o
- MR compatibility per engineering analysis o
- Bacterial Endotoxin Testing (BET)
- BET demonstrated the pyrogen limit specifications have been met o
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.
K010685, K942263, K880155, K122529, K033363, K971938, K011954
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.
K113369, K121771, K150090, K141407, K122160
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that they appear to be connected or overlapping.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 3, 2016
Biomet, Inc. Ms. Nicole Meredith Regulatory Affairs Project Manager 56 East Bell Drive PO Box 587 Warsaw, Indiana 46581
Re: K161592 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: October 4, 2016 Received: October 6, 2016
Dear Ms. Meredith:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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) K161592
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 (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 Systemknee surgeries providing that the tibial plate locking mechanism is not compromised 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 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.
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
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image shows the word "BIOMET" in a simple, sans-serif font. The letters are all capitalized and appear to be a dark gray color. The letters are evenly spaced and the word is horizontally oriented.
510(k) Summary — K161592
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: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nicole J. Meredith
Regulatory Affairs Project Manager
574-377-3718 |
| Date: | November 1, 2016 |
| Subject Device: | Trade Name: Persona Partial Knee System
Common Name: Knee Prosthesis
Classification Name:
HSX- prosthesis, knee, femorotibial, non-constrained, cemented metal/polymer (21 CFR §888 3520) |
Legally marketed devices to which substantial equivalence is claimed:
- Miller/Galante Unicompartmental Knee (K010685/K942263/K880155) ●
- Zimmer Unicompartmental Knee System (K122529/K033363)
- Repicci II Unicondylar Knee (K971938)
- Allegretto Unicompartmental Knee (K011954)
- Zimmer Persona Personalized Knee System (K113369/K121771/K150090) – reference device for A/P medial dimensions, MR conditional labeling, and materials
- Vanguard XP Knee System (K141407/K122160) – reference device for implant-specific accessories/instruments
Device Description
The Persona Partial Knee (PPK) System is a partial knee replacement for the medial compartment of the knee and is modular in design consisting of three components: a unicondylar cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, a unicondylar titanium (Ti-6Al-4V) alloy tibial tray, and a unicondylar articular surface manufactured using the previously cleared Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE).
The Persona Partial Knee System is compatible with the following devices:
- Zimmer Patellofemoral Joint Prosthesis (K070695)
5
Image /page/5/Picture/1 description: The image shows the word "BIOMET" in a simple, sans-serif font. The letters are all capitalized and appear to be a dark gray color. The letters are evenly spaced and the overall design is clean and modern.
Intended Use and Indications for Use
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 (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.
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 rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The Persona Partial Knee System and predicate devices have the same intended use; for replacement of one compartment of the knee. The predicate devices are intended for the medial or lateral compartment. The Persona Partial Knee System is intended for the medial compartment only. The Persona Partial Knee System and predicate devices are intended for cemented use.
- Materials: ●
- o The Persona Partial Knee femoral components are composed of the same material (Co-Cr-Mo alloy) as the Repicci II Unicondylar Knee (K971938) predicate
6
BIOMET
and the Zimmer Persona Personalized Knee System component (K113369) reference device.
- o The Personal Partial Knee articular surfaces are manufactured from the same material (Vivacit-E Vitamin E Highly Crosslinked Polyethylene) as the predicate Zimmer Unicompartmental Knee System (K122529) and in the Zimmer Persona Personalized Knee System reference device (K150090 and K121771).
- The Personal Partial Knee tibial components are composed the same material o (Ti-6Al-4V alloy) as that used in the Miller/Galante Unicompartmental Knee (K010685) and the Zimmer Unicompartmental Knee System (K033363) predicates, and the Zimmer Persona Personalized Knee System (K113369) reference device.
- Design Features: The Persona Partial Knee System incorporates similar design features as the predicate devices.
- Sterilization: The Persona Partial Knee System implants and predicate devices are provided sterile for single-use.
Summary of Performance Data
Results from mechanical tests and engineering analyses demonstrate the proposed PPK components are substantially equivalent to the predicate devices. No animal or clinical testing was required to support substantial equivalence. A description of the non-clinical tests and analyses performed are listed below.
- . Femoral Component
- o Cantilever fatigue per internal test method
- 3-Point Bending Fatigue per internal test method O
- Articular Surfaces
- Contact area per ASTM F2083 O
- Constraint per ASTM F2083 and ASTM F1223 O
- O Posterior Crush and Lift Off per internal test method
- Wear per engineering analysis O
- O Static locking mechanism strength per internal test method
- Tibial Components
- 3-Point bending fatigue per internal test method O
- System Compatibility
- Patellar component and PFJ compatibility per engineering analysis o
- MR compatibility per engineering analysis o
- Bacterial Endotoxin Testing (BET)
- BET demonstrated the pyrogen limit specifications have been met o
Substantial Equivalence Conclusion
The Persona Partial Knee System has the same or similar intended use, materials, and design characteristics as the predicate devices. Performance data and analyses demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.