(97 days)
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.
Porous components may be used cemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.
The Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including:
• Femoral components
• Articular surfaces
• Tibial components
• Stem extensions
• Femoral and tibial augments
• Femoral and tibial cones
The large modularity of the componentry of the Persona Revision knee system including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery.
This FDA 510(k) summary for the "Persona Revision Knee System" does not describe a study involving an AI/ML device or its performance criteria. It pertains to a physical medical device (a knee prosthesis) and the tests conducted are primarily mechanical and material property assessments, not related to AI/ML performance metrics like sensitivity, specificity, or reader studies.
Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study proving an AI/ML device meets them from the provided text. The document focuses on showing substantial equivalence of a knee implant to existing devices through non-clinical (mechanical, material, design) testing and intended use comparisons.
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October 25, 2018
Image /page/0/Picture/1 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.
Zimmer Inc. Nicole Meredith Regulatory Project Manager P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K181947
Trade/Device Name: Persona Revision 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: September 26, 2018 Received: September 27, 2018
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. 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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Peter G. Allen -S 2018.10.25 18:22:34 -04'00'
Mark N. Melkerson FOR Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181947
Device Name Persona® Revision Knee System
Indications for Use (Describe)
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.
Porous components may be used cemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment 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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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® Revision 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 708Warsaw, IN 46581-0708Establishment Registration Number: 1822565 |
|---|---|
| Contact Person: | Nicole J. MeredithRegulatory Project ManagerTelephone: (574) 377-3718Fax: (574) 372-4710 |
| Date: | July 18, 2018 |
| Subject Device: | Trade Name: Persona® Revision Knee SystemCommon Name: Knee Prosthesis |
| Classification Name:● MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (21 CFR 888.3565)● JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560)● OIY – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (21 CFR 888.3560) | |
| Predicate Devices: | Zimmer Persona K133737The Personalized Knee System K130143K123459K122765K121771K113369NexGen Complete Knee Solution K173057K152494 |
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| K960279 | ||
|---|---|---|
| K946150 | ||
| K933785 | ||
| NexGen TM Augments and Cones | K103517 | |
| K040630 | ||
| K031962 | ||
| K024161 | ||
| Vanguard SSK 360 Revision KneeSystem | K171054 | |
| K121149 | ||
| K093293 | ||
| K042757 | ||
| Natural-Knee II | K173057 | |
| K023528 | ||
| K013031 | ||
| K982903 | ||
| K973412 | ||
| K972501 | ||
| Purpose and Device Description: | The purpose of this submission is for introduction of thePersona Revision Knee System. | |
| The Persona Revision Knee System is a semi-constrainedtotal knee prosthesis consisting of anatomically shapedcomponents designed to resurface the articulating surfaceof the femoral and tibial bones including: | ||
| • Femoral components | ||
| • Articular surfaces | ||
| • Tibial components | ||
| • Stem extensions | ||
| • Femoral and tibial augments | ||
| • Femoral and tibial cones | ||
| The large modularity of the componentry of the PersonaRevision knee system including articular surfaces withdifferent levels of constraint, augments, cones and stemextensions provides numerous possible configurations tooptimally address the bone and joint condition of thepatient in a primary or revision TKA surgery. |
In addition, this submission includes the addition of MR conditional labeling for the Persona 14 x 30mm Tapered
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Stem Extension cleared under the K133737 on February 2, 2014.
Intended Use and Indications for Use: 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. Porous components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only. Summary of Technological The rationale for substantial equivalence is based on Characteristics: consideration of the following characteristics: ● Intended Use: Identical to the predicates Indications for Use: Identical to the predicates . ● Materials: Identical to the predicates
- Design Features: Similar to the predicates ●
- Sterilization: Identical to the predicates ●
Summarv of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests: ● Femoral Components
- Patellofemoral durability per internal test method O
- Patellofemoral lateral constraint per ASTM F1672 O
- Patellofemoral contact area and contact pressure O per ASTM F1672
- Posterior condyle fatigue per engineering analysis O
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- O Intercondylar notch and anterior chamfer strength per engineering analysis
- Anterior flange strength via finite element O analysis
- Stem housing cantilever fatigue per internal test O method
Articular Surfaces
- Wear per ISO 14243-1 o
- Anterior spine impingement via finite element o analysis
- Constraint per ASTM F2083 and ASTM F1223 O
- Contact area and contact pressure per ASTM O F2083
- Anterior lift-off per engineering analysis O
- Posterior lift-off per engineering analysis O
- Combined internal/external (I/E) and varus/valgus O (V/V) spine loading via finite element analysis
- Static varus/valgus constraint per internal test O method
- o Assembly/insertion force per internal test method
- Secondary lockdown screw assembly strength per O internal test method
- Secondary lockdown screw torque after gait-type o loading per internal test method
Tibial Components
- Cantilever fatigue per ASTM F1800 o
- Tibial stem housing cantilever fatigue per internal O test method
- Locking mechanism static shear strength per o engineering analysis
- Fixation stability per internal test method O
Augments
- O Shear attachment strength per internal test method
- Attachment screw assembly strength per internal O test method
Cones
- Tibial cone stress under physiologic loading per O finite element analysis
- Femoral cone stress under physiologic loading per o finite element analysis
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Stem Extensions
- Tibial taper connection axial pull-off and torsional O strength per ASTM F2009
- Femoral taper connection axial pull-off and O torsional strength per ASTM F2009
- Splined stem tip fatigue strength per internal test o method
- Cantilever fatigue via finite element analysis per O ASTM F1800
System
- Fretting/corrosion of modular junctions per o engineering analysis
- MR compatibility per engineering analysis O
- Testing to establish product non-pyrogenicity O
Backwards Compatibility with Persona Primary Knee System
- Persona Revision femoral components wear on o Persona Primary PS and CPS articular surfaces per engineering analysis
- Persona Revision femoral components posterior O crush loading of the Persona Primary PS and CPS articular surfaces per finite element analysis
- Persona Revision femoral components anterior O lift-off of the Persona Primary PS and CPS articular surfaces per engineering analysis
- Persona Revision femoral components posterior O lift-off of the Persona Primary PS and CPS articular surfaces per engineering analysis
- Contact area and contact pressure of the Persona o Revision femoral components with the Persona Primary PS and CPS articular surfaces per engineering analysis
- Tibiofemoral constraint of the Persona Revision O femoral components with the Persona Primary PS and CPS articular surfaces per engineering analysis
- Persona Revision femoral components anterior о spine impingement with the Persona Primary PS and CPS articular surfaces per engineering analysis
- Cantilever fatigue of the Persona Revision tibial O components with the Persona Primary PS and CPS articular surfaces and Persona Primary tibial
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components with Persona Revision articular surfaces per engineering analysis
. Clinical Tests:
- Clinical data was not deemed necessary for the subject device.
Substantial Equivalence Conclusion
The subject device has the same intended use and indications for use as the predicate devices. The subject device has similar technological characteristics to the predicates, and the performance data and analyses demonstrate 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 devices.
§ 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.