(77 days)
Not Found
No
The summary describes a knee implant system and its materials, with performance studies focused on mechanical properties and substantial equivalence to predicate devices. There is no mention of AI or ML.
Yes
The device is a prosthetic replacement for the knee joint, intended to treat various joint diseases and correct deformities, which falls under the definition of a therapeutic device.
No
Explanation: The device, the Klassic® Knee System, is intended for prosthetic replacement in total knee arthroplasty, not for diagnosing diseases or conditions. It is a treatment device, specifically an implant.
No
The device description clearly states it is a physical implant made of Cobalt-Chromium-Molybdenum alloy and Titanium alloy, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Klassic® Knee System is a prosthetic implant intended for surgical replacement of the knee joint. It is a physical device implanted into the body to restore function and alleviate pain.
- Lack of IVD Characteristics: The provided text does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes. The device's function is purely mechanical and structural.
Therefore, based on the provided information, the Klassic® Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Klassic® Knee System is intended for prosthetic replacement of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDID): 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
The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
MBH
Device Description
The Klassic Femur, Porous and the Klassic® Tibial Baseplate, Porous, are being introduced as line extensions for use with the Klassic® Knee System for uncemented implantation during total knee arthroplasty. The Klassic® Femur, Porous is manufactured from Cobalt-Chromium-Molybdenum alloy and features a cobalt chrome porous sintered coating for uncemented biologic fixation. The Klassic® Tibial Baseplate, Porous is manufactured from Titanium alloy and features a titanium porous sintered coating for uncemented biologic fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Engineering analyses were performed on the Klassic® Femur, Porous and the Klassic® Tibial Baseplate, Porous to evaluate the Tibial-Femoral Stability Characteristics, Stress Distributions and Range of Motion, and Patella-Femoral Resistance to Lateral Subluxation and Surface Stress Distribution, and Tibial Modular Disassembly Characteristics. Non-Clinical testing was performed per ASTM F1800 and per the FDA Guidance Document "Guidance document for testing orthopedic implants with modified metallic surfaces apposing bone or bone cement" dated April 28, 1994. The results of analysis and testing demonstrate that the subject Klassic® Femur, Porous and the Klassic® Tibial Baseplate, Porous, are substantially equivalent to the predicate devices. Additionally, the Klassic® Femur, Porous and the Klassic® Tibial Baseplate, Porous are in compliance with LAL testing requirements for orthopedic implants.
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.
K112906, K153776, K061223, K123486
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
§ 888.3565 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.
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2016
Total Joint Orthopedics, Inc. Mr. Chris Weaber Product Development, Regulatory Manager 1567 E. Stratford Avenue Salt Lake City, Utah 84106
Re: K162256
Trade/Device Name: Klassic® Femur, Porous; Klassic® Tibial Baseplate, Porous Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH Dated: August 26, 2016 Received: August 29, 2016
Dear Mr. Weaber:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162256
Device Name
Klassic® Femur, Porous, Klassic® Tibial Baseplate, Porous
Indications for Use (Describe)
The Klassic® Knee System is intended for prosthetic replacement of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDID): 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
The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Manufacturer: | Total Joint Orthopedics, Inc.
1567 E. Stratford Avenue
Salt Lake City, UT 84106
Phone: 801.486.6070
Fax: 801.486.6117 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Chris Weaber
Product Development, Regulatory Manager |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street, NW, 12th Floor
Washington, DC 20005
Phone: 202.552.5800
Fax: 202.552.5798 |
| Date Prepared: | August 10, 2016 |
| Device Trade Name: | Klassic® Femur, Porous
Klassic® Tibial Baseplate, Porous |
| Device Common Name: | Total knee replacement system |
| Classification: | 21 CFR §888.3565 Knee joint patellofemorotibial
metal/polymer porous-coated uncemented prosthesis
Class II |
| Product Code: | MBH |
Indications for Use:
The Klassic® Knee System is intended for prosthetic replacement 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 .
The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
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Device Description:
The Klassic Femur, Porous and the Klassic® Tibial Baseplate, Porous, are being introduced as line extensions for use with the Klassic® Knee System for uncemented implantation during total knee arthroplasty. The Klassic® Femur, Porous is manufactured from Cobalt-Chromium-Molybdenum alloy and features a cobalt chrome porous sintered coating for uncemented biologic fixation. The Klassic® Tibial Baseplate, Porous is manufactured from Titanium alloy and features a titanium porous sintered coating for uncemented biologic fixation.
Predicate Devices:
The Klassic Femur, Porous is substantially equivalent to the predicate Klassic® Knee System Femur (K112906) with respect to material, design, and function. The Klassic® Femur, Porous is substantially equivalent to the Exactech® Optetrak One Logic Porous Femoral Component (K153776) and the Wright Medical Advance® Total Knee System porous coated Femoral Components (K061223) with regards to material, function and indications for use without bone cement.
The Klassic® Tibial Baseplate, Porous is substantially equivalent to the predicate Klassic Knee System Tibial Baseplate (K112906) with respect to material, design, and function. The Klassic Tibial Baseplate, Porous is substantially equivalent to the Howmedica Osteonics Corp. Triathlon® Tritanium Tibial Baseplates (K123486) and the Wright Medical Advance Total Knee System porous coated Tibial Component (K061223) with regards to material, function and indications for use without bone cement.
Substantial Equivalence:
Engineering analyses were performed on the Klassic® Femur, Porous and the Klassic® Tibial Baseplate, Porous to evaluate the Tibial-Femoral Stability Characteristics, Stress Distributions and Range of Motion, and Patella-Femoral Resistance to Lateral Subluxation and Surface Stress Distribution, and Tibial Modular Disassembly Characteristics. Non-Clinical testing was performed per ASTM F1800 and per the FDA Guidance Document "Guidance document for testing orthopedic implants with modified metallic surfaces apposing bone or bone cement" dated April 28, 1994. The results of analysis and testing demonstrate that the subject Klassic® Femur, Porous and the Klassic® Tibial Baseplate, Porous, are substantially equivalent to the predicate devices. Additionally, the Klassic® Femur, Porous and the Klassic® Tibial Baseplate, Porous are in compliance with LAL testing requirements for orthopedic implants.