(121 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the knee implant and surgical instruments, with no mention of AI or ML.
Yes
The device is an implantable knee prosthesis intended for prosthetic replacement to treat various joint diseases and correct deformities, which are therapeutic interventions.
No
The device is an implantable knee prosthesis designed for prosthetic replacement of the knee joint. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the Klassic™ Knee System consists of implantable knee prostheses (hardware) and surgical instruments (hardware). There is no mention of any software component.
Based on the provided text, the Klassic™ Knee System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "prosthetic replacement" of the knee joint in patients with various conditions. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details implantable components (femoral, tibial, patellar) and surgical instruments. These are used in the body during surgery, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions in vitro.
Therefore, the Klassic™ Knee System is a surgical implant and associated instrumentation, not an IVD.
N/A
Intended Use / Indications for Use
The Klassic " Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): . avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis .
- Patients with failed previous surgery where pain, deformity, or dysfunction . persists
- Correctable varus-valgus deformity and moderate flexion contracture .
- Revision of a previously failed knee arthroplasty
- Patients who require a total knee replacement
Product codes
JWH
Device Description
The Klassic™ Knee System consists of two categories of devices: an implantable knee prosthesis and the various instruments needed to perform the surgery and implant the femoral, tibial and patellar components. The Klassic "Knee System allows for simple surgical use and addresses the needs of a wide patient population. The System also has streamlined instrumentation.
The Klassic™ Knee System is a cemented total knee joint replacement system intended for use in primary knee surgery. The System is a semiconstrained design and both the medial and lateral collateral ligaments must be intact. The Klassic" Knee System utilizes a symmetrical design, eliminating the need for left/right orientations. The patellofemorotibial prosthesis includes a metal femoral component, a tibial component consisting of a polyethylene tibial bearing fixed to a metal tibial baseplate, a polyethylene patellar component, a polyethylene dome extension, and a metal tibial insert set screw. The implantable components are provided sterile and are intended for single-use only in a single patient.
The Cobalt Chromium alloy (CoCr) femur has a symmetric design and is available in six sizes for cemented application to accommodate replacement of either left or right knees.
The Titanium alloy tibial baseplate has a symmetric design and is available in six sizes for cemented application. The tibial baseplate has a modular design to assemble with the tibial insert with a snap-in locking mechanism that is secured with the Titanium allov tibial insert set screw. The System includes two types of tibial inserts which can be used in cruciate retaining and cruciate sacrificing procedures. Both types of tibial inserts have a symmetric design, are composed of ultrahigh molecular weight polyethylene (UHMWPE) and are available in six sizes and four thicknesses (10-16mm). The System also includes a patella composed of UHMWPE which is available in four sizes. Additionally, the System includes a dome extension composed of UHMWPE that connects to the bottom of the tibial baseplate and is available in one size. The UHMWPE material has been utilized in previously cleared devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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)
Extensive bench testing was conducted on the Klassic™ Knee System to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate devices. Non-clinical testing assessed the following aspects of the device:
- Fatigue
- Disassembly
- Stability .
- Contact area and stress distributions .
- Range of motion .
- Biocompatibility .
- Sterilization and cleaning validations .
- Packaging and shelf life .
All testing was performed in accordance with recognized standards. Results confirm that all components of the Klassic" Knee System exhibit the appropriate characteristics for total knee joint replacement, and are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ortho Development Corporation, Balanced Knee™ System (K994370), Ortho Development Corporation, Balanced Knee™ System Ultracongruent Tibial Insert (K090705), Intermedics Orthopedics, Natural-Knee® II System (K936159), OMNI Life Science, Inc., Apex Knee™ System (K060192), Intermedics Orthopedics, Natural-Knee®/Apollo™ Knee (K925242, K935523), Howmedica Corp., Kinemax Plus Total Knee System (K910500)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SECTION 5 510(k) SUMMARY
510(k) Notification K | 2906
GENERAL INFORMATION
Applicant:
Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106 Phone: 801-486-6070 Fax: 801-486-6117
Contact Person:
Heather Lake Sr. Manager, Regulatory Affairs Experien Group, LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 Phone: 408-400-0856 Fax: 408-400-0865
Date Prepared: September 30, 2011
DEVICE INFORMATION
The Klassic™ Knee System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component.
Trade Name:
Klassic™ Knee System
Generic/Common Name:
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Classification:
21 CFR§888.3560, Class II
Product Code:
JWH
Page 1 of 24
1
SECTION 5 510(k) SUMMARY
PREDICATE DEVICE(S)
- Ortho Development Corporation, Balanced Knee™ System (K994370) .
- Ortho Development Corporation, Balanced Knee™ System Ultracongruent Tibial . Insert (K090705)
- Intermedics Orthopedics, Natural-Knee® II System (K936159) .
- OMNI Life Science, Inc., Apex Knee™ System (K060192) .
- Intermedics Orthopedics, Natural-Knee®/Apollo™ Knee (K925242, K935523) .
- Howmedica Corp., Kinemax Plus Total Knee System (K910500) .
INDICATIONS FOR USE
The Klassic " Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): . avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis .
- Patients with failed previous surgery where pain, deformity, or dysfunction . persists
- Correctable varus-valgus deformity and moderate flexion contracture .
- Revision of a previously failed knee arthroplasty
- Patients who require a total knee replacement
PRODUCT DESCRIPTION
The Klassic™ Knee System consists of two categories of devices: an implantable knee prosthesis and the various instruments needed to perform the surgery and implant the femoral, tibial and patellar components. The Klassic "Knee System allows for simple surgical use and addresses the needs of a wide patient population. The System also has streamlined instrumentation.
The Klassic™ Knee System is a cemented total knee joint replacement system intended for use in primary knee surgery. The System is a semiconstrained design and both the medial and lateral collateral ligaments must be intact. The Klassic" Knee System utilizes a symmetrical design, eliminating the need for left/right orientations. The patellofemorotibial prosthesis includes a metal femoral component, a tibial component consisting of a polyethylene tibial bearing fixed to a metal tibial baseplate, a polyethylene patellar component, a polyethylene dome extension, and a metal tibial insert set screw. The implantable components are provided sterile and are intended for single-use only in a single patient.
The Cobalt Chromium alloy (CoCr) femur has a symmetric design and is available in six sizes for cemented application to accommodate replacement of either left or right knees.
Page 2 of
2
SECTION 5 510(k) SUMMARY
The Titanium alloy tibial baseplate has a symmetric design and is available in six sizes for cemented application. The tibial baseplate has a modular design to assemble with the tibial insert with a snap-in locking mechanism that is secured with the Titanium allov tibial insert set screw. The System includes two types of tibial inserts which can be used in cruciate retaining and cruciate sacrificing procedures. Both types of tibial inserts have a symmetric design, are composed of ultrahigh molecular weight polyethylene (UHMWPE) and are available in six sizes and four thicknesses (10-16mm). The System also includes a patella composed of UHMWPE which is available in four sizes. Additionally, the System includes a dome extension composed of UHMWPE that connects to the bottom of the tibial baseplate and is available in one size. The UHMWPE material has been utilized in previously cleared devices.
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the Klassic" Knee System are similar to the predicate devices. Performance data were provided to support the determination of substantial equivalence.
SUBSTANTIAL EQUIVALENCE
The proposed indications for use for the Klassic™ Knee System are substantially equivalent to the indications for use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Klassic" Knee System is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Extensive bench testing was conducted on the Klassic™ Knee System to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate devices. Non-clinical testing assessed the following aspects of the device:
- Fatigue
- Disassembly
- Stability .
- Contact area and stress distributions .
- Range of motion .
- Biocompatibility .
- Sterilization and cleaning validations .
- Packaging and shelf life .
All testing was performed in accordance with recognized standards. Results confirm that all components of the Klassic" Knee System exhibit the appropriate characteristics for total knee joint replacement, and are substantially equivalent to the predicate devices.
Page 3 of 4
3
SECTION 5 510(k) Summary
CONCLUSION
The results of the non-clinical testing verify that the Klassic" Knee System functions as intended and exhibits the appropriate characteristics for total knee joint replacement. The Klassic "Knee System is substantially equivalent to the predicate devices in terms of technological characteristics, intended use and performance.
SUMMARY
The Klassic" Knee System is substantially equivalent to the predicate devices.
Page 4 of 4
4
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 1 2012
Total Joint Orthopedics, Inc. % Ms. Heather Lake Regulatory Consultant for Total Joint Orthopedics, Inc. Experien Group, LLC 755 N. Mathilda Avenue Sunnyvale, California 94085
Re: K112906
Trade/Device Name: Klassic Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH
Dated: January 19, 2012 Received: January 20, 2012
Dear Ms. Lake:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreaty to region) to regard date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetion (110) that to nevice, subject to the general controls provisions of the Act. The I ou may, uleretore, mains of the Act include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Treasonote. ODAC as , 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 If your device is classified (bes acon). 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 found in the South of Incernents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised that I Dris bloodated or our device complies with other requirements of the Act that I DA has made a actering administered by other Federal agencies. You must
5
Page 2 - Ms. Heather Lake
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 or ice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set do records adverse oread) (2) 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 n you acc.il/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,
Sincerely yours,
FOR Peter Thom
Mark N. Melkerson Dep. Lirr Dir.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 112906
Device Name: Klassic™ Knee System
Indications For Use:
The Klassic™ Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): . avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis .
- Patients with failed previous surgery where pain, deformity, or dysfunction . persists
- Correctable varus-valgus deformity and moderate flexion contracture .
- Revision of a previously failed knee arthroplasty .
- Patients who require a total knee replacement .
Prescription Use_X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
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| and the country of the country of the county of the county of the county of the county of the county of the county of the country of the country of the county of the county o |
Rical Circhopdatorice Evaluation (ODE) and Restorative Devices
510(k) Number K112986