(57 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.
This device is intended to be used with cemented knee constructs.
The Persona 14 x+30mm Tapered Stem Extension is intended for implantation for total knee arthroplasty (TKA) when supplemental tibial baseplate support is needed. Extending into the intramedullary canal from the base of the Persona Cemented Stemmed Tibia Baseplate, the Persona 14 x+30mm Stem Extension provides supplemental support and shields the fixation interfaces from excessive stress by resisting bending and torsional moments. The subject device is intended to be used with cement knee constructs.
Here's an analysis of the provided text regarding the Zimmer® Persona The Personalized Knee System 14 x+30mm Tapered Stem Extension, focusing on acceptance criteria and the supporting study:
The provided document (K133737) is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It's important to note that this device is a physical implant (a knee system component), not an AI/software device. Therefore, many of the requested fields related to AI study design (like MRMC, human readers, ground truth for training data, etc.) are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in a table format with pass/fail thresholds. Instead, it describes "performance characteristics" and the "Test Results" demonstrating that the device meets these characteristics. The context implies that the acceptable outcome is for the device to demonstrate sufficient strength or to be assessed for risk in comparison to existing devices, aligning with established FDA guidance for orthopedic implants.
| Property or Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Fatigue Test of the Persona Tibia Keel and Stem Extension | Demonstrate sufficient fatigue strength to survive expected worst-case loading conditions, likely in line with predicate devices and FDA guidance. | "Demonstrated that the Persona tibia keel and stem extension taper junction has sufficient fatigue strength to survive expected worst case loading conditions." |
| Static Axial and Torsional Strength of the Persona Stem Extension Taper | Demonstrate adequate static axial and torsional strength, likely in line with predicate devices and FDA guidance for modular implant components. | "Demonstrated the static axial and torsional strength of the Persona stem extension taper mechanism." |
| The Risk of Cortex Perforation for Persona Tibial Components with +30MM Stem | Assess and quantify the potential risk of cortex perforation, ideally demonstrating it is comparable to or acceptable relative to predicate devices like the NexGen tibial implant when implanted similarly. (No explicit "acceptance" is stated, but rather an assessment). | "Assessed the potential risk of cortex perforation of the Persona stemmed tibial implant with the 14 x +30mm stem extension compared to the NexGen tibial implant when implanted in the same manner." (The summary does not provide the quantitative outcome of this assessment, only that it was conducted.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (e.g., number of test specimens) for each bench test. For mechanical tests like fatigue and strength, multiple samples are typically tested, but no numbers are provided here.
- Data Provenance: The data is non-clinical bench testing, meaning it was generated in a laboratory setting, not from human or animal subjects. The location of the testing is not explicitly stated but would typically be in the sponsor's (Zimmer, Inc.) labs or a qualified contract testing facility. This is retrospective in the sense that the testing was performed and then reported, but it is not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This question is not applicable as the study involves mechanical bench testing of an orthopedic implant component, not an AI or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these tests is defined by engineering principles and measurement of physical properties.
4. Adjudication Method for the Test Set
This question is not applicable. Mechanical tests rely on objective measurements from standardized equipment rather than subjective human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This question is not applicable. This is a submission for a physical orthopedic implant component, not a diagnostic device or AI system that would involve human readers. Clinical data and conclusions "were not needed for this device."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical knee implant component, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical study is defined by:
- Mechanical Properties: Measured physical characteristics such as fatigue life, axial strength, torsional strength.
- Engineering Standards and FDA Guidance: Compliance with relevant ASTM (American Society for Testing and Materials) or ISO (International Organization for Standardization) standards (implied by the FDA guidance documents cited) that define appropriate testing methodologies and performance expectations for such devices.
- Comparison to Predicate Devices: Performance relative to legally marketed predicate devices, demonstrating similarity in performance characteristics.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is a physical medical device and not an AI or machine learning model.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reasons as #8.
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FEB - 4 2014
Summary of Safety and Effectiveness
| Sponsor: | Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Pauline A. Shand Associate Project Manager, Regulatory Affairs Telephone: (574) 372-4765 Fax: (574) 372-4605 |
| Date: | January 24, 2014 |
| Trade Name: | Zimmer® Persona The Personalized Knee System 14 x+30mm Tapered Stem Extension |
| Product Codes / Device: | JWH, OIY |
| Regulation Numbers / Description: | 21 CFR § 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented |
| Predicate Device: | Persona Personalized Knee System (K113369, cleared March 27, 2012) |
| M-G II® Total Knee System Stemmed Tibial Baseplate Components (K050723, cleared April 20, 2005) | |
| NexGen® Complete Knee Solution (K933785, cleared January 30, 1995) | |
| Device Description: | The Persona 14 x+30mm Tapered Stem Extension is intended for implantation for total knee arthroplasty (TKA) when supplemental tibial baseplate support is needed. Extending into the intramedullary canal from the base of |
Image /page/0/Picture/5 description: The image shows the text "510(k) Summary Page 1 of 3 January 28, 2014". The text indicates that the image is the first page of a 510(k) summary document. The document is dated January 28, 2014. The document is 3 pages long.
Image /page/0/Picture/6 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside it. Below the circle is the word "zimmer" in a sans-serif font.
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Intended Use:
from excessive stress by resisting bending and torsional moments. The subject device is intended to be used with cement knee constructs.
the Persona Cemented Stemmed Tibia Baseplate, the
supplemental support and shields the fixation interfaces
Persona 14 x+30mm Stem Extension provides
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, ﺳ 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.
- ﺴﺖ 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.
This device is intended to be used with cemented knee constructs.
Comparison to Predicate Device:
The proposed Zimmer® Persona The Personalized Knee System 14 x+30mm Tapered Stem Extension is similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices.
Performance Data (Nonclinical and/or Clinical):
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Non-Clinical Performance and Conclusions:
Bench testing outlined below was conducted according to FDA guidance documents:
FDA Guidance: Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and
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510(k) Summary Page 3 of 3 January 28, 2014
Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses
FDA Guidance: Guidance document for testing nonarticulating, "mechanically locked", modular implant components.
FDA Guidance: Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement
| Property orCharacteristic | Test Results |
|---|---|
| Fatigue Test of the Persona TibiaKeel and Stem Extension | Demonstrated that the Persona tibia keel and stem extensiontaper junction has sufficient fatigue strength to surviveexpected worst case loading conditions. |
| Static Axial and Torsional Strengthof the Persona Stem ExtensionTaper | Demonstrated the static axial and torsional strength of thePersona stem extension taper mechanism. |
| The Risk of Cortex Perforation forPersona Tibial Components with+30MM Stem | Assessed the potential risk of cortex perforation of thePersona stemmed tibial implant with the 14 x +30mm stemextension compared to the NexGen tibial implant whenimplanted in the same manner. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2014
Zimmer, Incorporated % Ms. Pauline A. Shand Associate Project Manager, Regulatory Affairs Zimmer, Incorporated P.O. Box 708 Warsaw, Indiana 46581
Re: K133737
Trade/Device Name: Zimmer® Persona The Personalized Knee System 14 x+30mm Tapered Stem Extension
Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II Product Code: JWH, OIY Dated: December 6, 2013 Received: December 9, 2013
Dear Ms. Shand:
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
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Page 2 - Ms. Pauline A. Shand
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Vincen伺服@evlin -S
for 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): K133737
Device Name:
Zimmer® Persona The Personalized Knee System 14 x+30mm Tapered Stem Extension
Indications for Use:
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. ー
- । Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral ﺍ 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.
This device is intended to be used with cemented knee constructs.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page 1 of 1
§ 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.