(88 days)
Not Found
No
The summary describes a mechanical knee prosthesis and bench testing of its material properties and wear characteristics. There is no mention of software, algorithms, image processing, or any other indication of AI/ML technology.
Yes.
The device's intended use is to replace a portion of the knee joint in patients with painful and/or disabling knee joints due to various conditions, aiming to alleviate pain and restore function. This aligns with the definition of a therapeutic device, which provides treatment or therapy for a disease or condition.
No
The device is described as a prosthesis that replaces part of the knee, indicating it is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "prosthesis that replaces only one compartment of the knee condyles," indicating it is a physical implant, not software. The performance studies also focus on material characteristics and mechanical testing of the physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) to replace damaged knee joints. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a prosthesis implanted into the knee joint, which is an in vivo application.
- Performance Studies: The performance studies focus on bench testing related to the material properties and mechanical performance of the implant, not on the analysis of biological specimens.
Therefore, the Zimmer Unicompartmental Knee System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zimmer Unicompartmental Knee System is indicated for patients with:
- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
- Previous tibial condyle or plateau fractures with loss of anatomy or function.
- Varus or valgus deformities.
- Revision of previous arthroplasty procedures.
These devices are indicated for cemented use only.
The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Product codes (comma separated list FDA assigned to the subject device)
HSX, OIY
Device Description
The Zimmer Unicompartmental Knee System (ZUK) is a prosthesis that replaces only one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and also allows unconstrained internal/external rotation between the femoral and tibial components. This movement is limited only by the ligaments and other soft tissues surrounding the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Non-Clinical Performance and Conclusions:
Vivacit-E material characteristics for the Zimmer Unicompartmental Knee System (ZUK) are identical to the predicate Zimmer Vivacit-E Acetabular Polyethylene Liners (K120370). In contrast to conventional polyethylene, the Vivacit-E material is delamination resistant and exhibits a reduction in wear according to knee simulator bench testing.
Bench testing outlined in table 1, below, was conducted according to FDA guidance documents:
Property or Characteristic: Effect of prolonged aging on the wear performance of vitamin-E IT Liner
Test Results: Demonstrated that prolonged accelerated aging does not significantly affect wear performance of Vivacit E material.
Property or Characteristic: Evaluation of the Delamination Resistance of Vivacit-E Ultra High Molecular Weight Polyethylene
Test Results: Demonstrated that Vivacit E material is delamination resistant.
Property or Characteristic: Wear Testing of Zimmer Unicompartmental Knee (ZUK) Vivacit-E UHMWPE Articular Surfaces under Load and Motion Curves from the ISO-14243 Standard, Report
Test Results: Demonstrated that the wear characteristics of the Zimmer Unicompartmental Knee Vivacit-E articular surfaces are sufficient to survive expected in vivo loading conditions.
Property or Characteristic: Fatigue Evaluation of the Zimmer Unicompartmental Knee (ZUK) Vivacit-E UHMWPE Articular Surface Locking Mechanism
Test Results: Demonstrated adequate resistance of the modular articular surfaces to disassembly.
Property or Characteristic: ZUK VE Posterior Edge Crush Fatigue Strength Evaluation
Test Results: Demonstrated posterior edge crush fatigue strength is sufficient to survive expected in vivo loading conditions.
Property or Characteristic: Human Factors Comparison of Manual Assembly of the Zimmer Unicompartmental Knee (ZUK) Vivacit-E UHMWPE Articular Surfaces
Test Results: Demonstrated that assembly force required to insert the Zimmer Unicompartmental Knee Vivacit-E articular surfaces is appropriate for users.
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
§ 888.3520 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
K122529 ('/3)
Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside. Below the circle, the word "zimmer" is written in a stylized font.
NOV 1 6 2012
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
Summary of Safety and Effectiveness
Sponsor:
Contact Person:
Date:
Trade Name:
Product Code / Device:
Regulation Number / Description:
Predicate Device:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Mark D. Warner Senior Specialist, Regulatory Affairs Telephone: (574)-372-4150 Fax: (574) 372-4605
August 17, 2012
Zimmer® Unicompartmental Knee System Vivacit-E® Articular Surface
HSX - Prosthesis, knee, femorotibial, nonconstrained, cemented, metal/polymer
OIY - Prosthesis, knee, patellofemorotibial, semiconstrained, cemented, polymer + additive / metal / polymer + additive
21 CFR § 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
21 CFR § 888.3560 - Knee joint, patellofemorotibial, polymer / metal / polymer, semi-constrained, cemented prosthesis
Zimmer Unicompartmental Knee System, manufactured by Zimmer, Inc. (K033363, cleared January 6, 2003)
Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, manufactured by Zimmer, Inc. (K120370, cleared June 4, 2012)
1
K122S29(²/₃)
EITM Antioxidant Infused Technology, Manufactured by Biomet Manufacturing Corp. (K 100048, cleared March 9, 2010)
The Zimmer Unicompartmental Knee System (ZUK) is a prosthesis that replaces only one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and also allows · unconstrained internal/external rotation between the femoral and tibial components. This movement is limited only by the ligaments and other soft tissues surrounding the device.
The Zimmer Unicompartmental Knee System is indicated for patients with:
- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
- Previous tibial condyle or plateau fractures with loss of anatomy or function.
- Varus or valgus deformities.
- Revision of previous arthroplasty procedures.
These devices are indicated for cemented use only.
The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
The proposed Zimmer Unicompartmental Knee System components are similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Non-Clinical Performance and Conclusions:
Vivacit-E material characteristics for the Zimmer Unicompartmental Knee System (ZUK) are identical to the predicate Zimmer Vivacit-E Acetabular Polyethylene Liners (K120370). In contrast to conventional polyethylene, the Vivacit-E material is delamination resistant and exhibits a
Device Description:
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
2
K122529(³/₃)
reduction in wear according to knee simulator bench testing.
Bench testing outlined in table 1, below, was conducted according to FDA guidance documents:
| Property or
| Characteristic | Test Results |
|---|---|
| Effect of prolonged aging on the wear | |
| performance of vitamin-E IT Liner | Demonstrated that prolonged accelerated aging does |
| not significantly affect wear performance of Vivacit | |
| E material. | |
| Evaluation of the Delamination | |
| Resistance of Vivacit-E Ultra High | |
| Molecular Weight Polyethylene | Demonstrated that Vivacit E material is delamination |
| resistant. | |
| Wear Testing of Zimmer | |
| Unicompartmental Knee (ZUK) Vivacit-E | |
| UHMWPE Articular Surfaces under | |
| Load and Motion Curves from the ISO- | |
| 14243 Standard, Report | Demonstrated that the wear characteristics of the |
| Zimmer Unicompartmental Knee Vivacit-E articular | |
| surfaces are sufficient to survive expected in vivo | |
| loading conditions. | |
| Fatigue Evaluation of the Zimmer | |
| Unicompartmental Knee (ZUK) Vivacit-E | |
| UHMWPE Articular Surface Locking | |
| Mechanism | Demonstrated adequate resistance of the modular |
| articular surfaces to disassembly. | |
| ZUK VE Posterior Edge Crush Fatigue | |
| Strength Evaluation | Demonstrated posterior edge crush fatigue strength |
| is sufficient to survive expected in vivo loading | |
| conditions. | |
| Human Factors Comparison of Manual | |
| Assembly of the Zimmer | |
| Unicompartmental Knee (ZUK) Vivacit-E | |
| UHMWPE Articular Surfaces | Demonstrated that assembly force required to insert |
| the Zimmer Unicompartmental Knee Vivacit-E | |
| articular surfaces is appropriate for users. |
Table 1: Bench Performance Testing Overview
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 16, 2012
Zimmer, Incorporated % Mr. Mark D. Warner Senior Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K122529
Trade/Device Name: Zimmer® Unicompartmental Knee System Vivacit-E® Articular Surface
Regulation Number: 21 CFR 888.3520
Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
Regulatory Class: Class II Product Code: HSX, OIY Dated: August 17, 2012 Received: August 20, 2012
Dear Mr. Warner:
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
4
Page 2 - Mr. Mark D. Warner
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. 1
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.htm 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Laurence D. Coyne
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Traditional 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): K122529
Device Name: Zimmer Unicompartmental Knee System
Indications for Use: .
These devices are indicated for patients with:
-
Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
-
Previous tibial condyle or plateau fractures with loss of anatomy or function.
-
Varus or valgus deformities.
-
Revision of previous arthroplasty procedures.
These devices are indicated for cemented use only.
The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Ais
(Division Sign-Off) Division of Orthopedic Devices KI22529 510(k) Number_
Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)