(269 days)
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 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.
The subject Persona Personalized Knee System components are identical to the predicate Persona Personalized Knee System components. Introduction of a kinematic alignment technique for use with the Persona Personalized Knee System CR and UC components does not change the intended use or the fundamental scientific technology of the associated implants.
The provided text is a 510(k) summary for the Zimmer® Persona® Personalized Knee System, focusing on the addition of a kinematic alignment surgical technique. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/medical device. Instead, it details the regulatory process for a knee replacement system.
Therefore, I cannot extract the requested information from the provided document. The document describes a traditional medical device (knee implant) rather than a software-as-a-medical-device (SaMD) or an AI-powered diagnostic device, which typically involves the kind of performance studies and acceptance criteria you've asked about (sensitivity, specificity, AUROC, etc.).
The "Summary of Performance Data" section lists non-clinical tests related to the mechanical performance of the knee system, not diagnostic accuracy or AI model performance.
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May 17, 2018
Zimmer, Inc. Nicole Meredith Regulatory Affairs Project Manager P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K172524
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, OIY, JWH Dated: April 13, 2018 Received: April 16, 2018
Dear Nicole 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172524
Device Name
Zimmer® 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, stem extension, 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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510(k) Summary – K172524
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Zimmer® Persona® The Personalized 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. MeredithProject Manager, Regulatory AffairsTelephone: (574) 377-3718Fax: (574) 372-4710 |
| Date: | May 08, 2018 |
| Subject Device: | Trade Name: Zimmer® Persona® The Personalized KneeSystemCommon Name: Knee ProsthesesClassification Name:MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (21 CFR 888.3565) OIY – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (21 CFR 888.3560) JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560) |
| Predicate Device(s): | The predicate devices are the Zimmer Persona Personalized Knee System CR and UC components, manufactured by Zimmer, Inc.: K113369, cleared March 27, 2012 K121771, cleared November 7, 2012 K122765, cleared November 9, 2012 K122745, cleared December 5, 2012 K130143, cleared February 22, 2013 K142787, cleared December 22, 2014 |
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Purpose and Device Description:
Intended Use and Indications for Use:
The purpose of this submission is the addition of a kinematic alignment surgical technique for use with the predicate/subject devices.
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 ioint 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.
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Summary of Technological Characteristics:
The addition of a kinematic alignment surgical technique for use with the subject devices does not impact the materials, design features or dimensions, packaging, or sterilization.
Summary of Performance Data (Nonclinical and/or Clinical):
Non-Clinical Tests: ●
- Patellofemoral joint kinematics and durability o assessment
- Patellofemoral joint under-stuffing assessment O
- Tibiofemoral joint kinematics assessment O
- Tibial perforation analysis O
- Kinematic alignment outcomes data review O
- Cadaveric validation O
- Testing to establish product non-pyrogenicity O
- Clinical Tests: ●
- Clinical data was not deemed necessary for the o subject device.
Substantial Equivalence Conclusion:
The subject Persona Personalized Knee System components are identical to the predicate Persona Personalized Knee System components. Introduction of a kinematic alignment technique for use with the Persona Personalized Knee System CR and UC components does not change the intended use or the fundamental scientific technology of the associated implants. Performance data and analyses demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate device.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
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.(b)
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.