(60 days)
Not Found
No
The document does not mention AI, ML, or related terms in the device description, intended use, or performance studies. The performance studies focus on mechanical testing and analysis using a database of CT scans, which does not inherently indicate AI/ML use.
Yes
The device, a Persona Natural Tibia Baseplate, is indicated for patients with severe knee pain and disability stemming from various conditions, including arthritis and avascular necrosis, and replaces the proximal portion of the tibia. Its purpose is to alleviate symptoms and restore function in individuals with these medical conditions, aligning with the definition of a therapeutic device.
No
The device is described as a replacement for part of the tibia, intended for cemented fixation in knee surgeries, not for diagnosing conditions.
No
The device description explicitly states it is a "Tibia Baseplate," which is a physical implant, not software. The performance studies also describe testing of physical components like fixation and fatigue.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description and intended use: The provided information clearly describes a Persona Natural Tibia Baseplate, which is a surgical implant designed to replace a portion of the tibia in patients with severe knee pain and disability. This is a surgical device, not a diagnostic test performed on a sample.
- Lack of diagnostic function: The device's purpose is to provide structural support and improve knee function, not to diagnose a condition.
Therefore, based on the provided information, this device falls under the category of a surgical implant and not an In Vitro Diagnostic.
N/A
Intended Use / 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.
This device is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Persona Natural Tibia Baseplate is designed to replace the proximal portion of the tibia via cemented fixation as part of the Persona Personalized Knee System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, tibia, femoral condyle
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)
The following tests have been completed in support of the changes to the Persona Natural Tibia Baseplate: Fixation Testing, Cantilever Fatigue Testing, Bending Fatigue Testing of the keel and stem extension junction, and Cortical Impingement and Perforation Analysis using a database of computed tomography (CT) segmented tibial bones.
Clinical data and conclusions were not needed for this device.
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
§ 888.3560 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.
0
K122765 ($\frac{1}{2}$)
NOV 9 2012
510 Summary of Safety and Effectiveness
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Nicole J. Meredith
Associate Project Manager, Regulatory Affairs
Telephone: (574) 372-4517
Fax: (574) 372-4605 |
| Date: | September 7, 2012 |
| Trade Name: | Persona™ Natural Tibia™ Baseplate and
Instrumentation |
| Product Code / Device: | JWH - prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer |
| Regulation Number / Description: | 21 CFR § 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis |
| Predicate Device: | Persona™ Natural Tibia™ Baseplate and
Instrumentation, manufactured by Zimmer Inc.,
K113369, cleared March 27, 2012 |
| Device Description: | The Persona Natural Tibia Baseplate is designed to replace the proximal portion of the tibia via cemented fixation as part of the Persona Personalized Knee System. |
| Intended 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. |
1
K122765(²/₂)
- -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 for cemented use only.
The Persona Natural Tibia Baseplate and Instrumentation is similar or identical in intended use, material, sterility, and performance characteristics to the predicate devices.
Non-Clinical Performance and Conclusions:
The following tests have been completed in support of the changes to the Persona Natural Tibia Baseplate: Fixation Testing, Cantilever Fatigue Testing, Bending Fatigue Testing of the keel and stem extension junction, and Cortical Impingement and Perforation Analysis using a database of computed tomography (CT) segmented tibial bones.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 9, 2012
Zimmer, Incorporated % Ms. Nicole J. Meredith Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K122765
Trade/Device Name: Persona™ Knee System 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 Dated: September 7, 2012
Received: September 10, 2012
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
3
Page 2 - Ms. Nicole J. Meredith
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Unknown K122765
Device Name:
Persona™ Knee System
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. ﻴﻴﻴ
- 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 for cemented use only.
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)
Aft
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
V- 27765 510(k) Number
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