(60 days)
No
The summary describes a knee implant system and its materials, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a prosthetic replacement for the knee joint, intended to treat conditions like degenerative joint disease and inflammatory joint disease, thereby alleviating pain and restoring function. This aligns with the definition of a therapeutic device designed to cure, treat, mitigate, or prevent disease.
No
The device is a knee replacement system used for prosthetic replacement and revision surgeries, not for diagnosing medical conditions.
No
The device description clearly states it is a physical implant made from titanium alloy, intended for surgical implantation. It also details bench testing and engineering analyses related to the physical properties of the implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a prosthetic replacement of the knee joint for various conditions. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a component of a knee system manufactured from titanium alloy. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Anatomical Site: The anatomical site is the knee joint, which is where the implant is placed, not where a diagnostic sample is taken from.
- Performance Studies: The performance studies focus on the mechanical properties and wear characteristics of the implant, not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Klassic® Knee System is a therapeutic device used to replace a damaged joint.
N/A
Intended Use / 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.
Product codes
JWH, OIY
Device Description
The Klassic® Femur with Aurum®, is being introduced as a line extension for use with the Klassic® Knee System for cemented implantation during total knee arthroplasty. The Klassic® Femur with Aurum® is manufactured from Titanium alloy (Ti6Al4V per ASTM F136) with a titanium nitride surface.
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)
Non-Clinical Bench Testing and Engineering analyses were performed on the Klassic® Femur with Aurum® to evaluate Strength of the titanium nitride coating. Fatigue Testing, Knee Simulator Wear, Tibial-Femoral Stability Characteristics, Tibial-Femoral Contact Stress and Range of Motion, and Patella-Femoral Resistance to Lateral Subluxation and Surface Stress Distribution. All results of the testing and analyses indicate that the subject Klassic® Femur with Aurum® is substantially equivalent to the predicate components. Additionally, the Klassic® Femur with Aurum® is also in compliance with LAL testing requirements for orthopedic implants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
July 23, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Total Joint Orthopedics, Inc. % Holly Rhodes VP, Orthopedic Regulatory Affairs Mcra, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001
Re: K211602
Trade/Device Name: Klassic® Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH. OIY Dated: May 24, 2021 Received: May 24, 2021
Dear Holly Rhodes:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211602
Device Name Klassic Knee System
Indications for Use (Describe)
- The Klassic® Knee System is intended for prosthetic replacement of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NID): 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
Director of Research and Development
cweaber@tjoinc.com | |
| Prepared By: | MCRA, LLC
1050 K Street NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5800
Fax: 202.552.5798 | |
| Date Prepared: | July 23, 2021 | |
| Device Trade Name: | Klassic® Knee System | |
| Device Common Name: | Total knee replacement system | |
| Classification: | 21 CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented prosthesis
Class II | |
| Product Codes: | JWH, OIY | |
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 with Aurum®, is being introduced as a line extension for use with the Klassic® Knee System for cemented implantation during total knee arthroplasty. The Klassic® Femur with Aurum® is manufactured from Titanium alloy (Ti6Al4V per ASTM F136) with a titanium nitride surface.
Predicate and Reference Devices:
The Klassic® Femur with Aurum® is substantially equivalent to the femoral components cleared as part of the Klassic® Knee System Femur (K112906) which serves as the primary predicate. The subject Klassic® Femur with Aurum® is identical to the predicate with respect to its intended use, articulating geometry, range of motion, function, and method of fixation. The subject femoral component differs from the predicate with respect to its material (i.e., the subject femoral component is made from titanium alloy with a titanium nitride surface: the predicate is made from CoCr alloy).
The titanium femoral components cleared as part of the Personalized Knee System (K142787) serve as a reference device. The subject device and Persona femoral components are made of identical materials with an identical titanium nitride surface.
Substantial Equivalence:
Non-Clinical Bench Testing and Engineering analyses were performed on the Klassic® Femur with Aurum® to evaluate Strength of the titanium nitride coating. Fatigue Testing, Knee Simulator Wear, Tibial-Femoral Stability Characteristics, Tibial-Femoral Contact Stress and Range of Motion, and Patella-Femoral Resistance to Lateral Subluxation and Surface Stress Distribution. All results of the testing and analyses indicate that the subject Klassic® Femur with Aurum® is substantially equivalent to the predicate components. Additionally, the Klassic® Femur with Aurum® is also in compliance with LAL testing requirements for orthopedic implants.