(370 days)
No
The summary describes a knee implant system and its components, focusing on materials and mechanical properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a prosthetic replacement for the knee, intended to treat various joint diseases and correct deformities, which are therapeutic interventions.
No
Explanation: The device is a prosthetic knee system intended for replacement of joints, not for diagnosing conditions.
No
The device description clearly states it is adding "Tibial Inserts," which are physical components of a knee replacement system, not software. The performance studies also focus on bench testing of these physical components.
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 for treating various knee conditions. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a knee system with tibial inserts made of a specific material. This aligns with a physical implant, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory testing.
The device is a surgical implant intended for the treatment of knee joint issues.
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 with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®, which are indicated for cementless use.
Product codes
JWH, OIY, MBH
Device Description
The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts and Ultra-PS® Tibial Inserts, which are fabricated with E^X Poly, to the Klassic® Knee System. E^X Poly is a crosslinked UHMWPE containing alpha-tocopherol. The subject Klassic® Knee CR/Congruent and Ultra-PS® Tibial Inserts are available in various sizes and thicknesses to match patient anatomy.
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
Bench testing and engineering analyses were performed on subject Klassic® Knee CR/Congruent and Ultra-PS® Tibial Inserts Knee Components with E^X Poly to evaluate wear, tibial-femoral stability characteristics, stress distributions and range of motion and tibial modular disassembly characteristics. The results of these analyses and testing indicate that the subject CR/Congruent and Ultra-PS® Tibial Inserts with E^X Poly are substantially equivalent to the predicate components. The biocompatibility of the subject tibial inserts was evaluated in accordance with FDA's Biocompatibility guidance document. Lastly, the subject tibial inserts are in compliance with LAL testing requirements for orthopedic implants.
Key Metrics
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
June 22, 2022
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Total Joint Orthopedics, Inc. % Holly Rhodes VP, Orthopedic Regulatory Affairs MCRA, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001
Re: K211877
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. MBH Dated: May 19, 2022 Received: May 19, 2022
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211877
Device Name Klassic Knee System
Indications for Use (Describe)
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 with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®, 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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3
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 |
| Prepared By: | MCRA, LLC
803 7th Street, NW, Third Floor
Washington, DC 20001
Phone: 202.552.5800 |
| Date Prepared: | June 21, 2022 |
| Device Trade Name: | Klassic Knee System |
| Device Common Name: | Tibial Inserts |
| Regulations: | 21 CFR 888.3560 – Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
21 CFR 888.3565 Knee joint patellofemorotibial metal/polymer
porous-coated uncemented prosthesis |
| Classification: | Class II |
| Product Codes: | JWH, OIY, 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 with Cobalt 3D™, and the Klassic® Tibial Baseplate with Ti-Coat®, which are indicated for cementless use.
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Device Description:
The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts and Ultra-PS® Tibial Inserts, which are fabricated with E^X Poly, to the Klassic® Knee System. E^X Poly is a crosslinked UHMWPE containing alpha-tocopherol. The subject Klassic® Knee CR/Congruent and Ultra-PS® Tibial Inserts are available in various sizes and thicknesses to match patient anatomy.
Predicate Devices:
The subject Klassic® Knee CR/Congruent and Ultra-PS® Tibial Inserts with E^X Poly are substantially equivalent to the primary predicate Klassic® Knee System Tibial Inserts with E-link Poly (K180159) with respect to indications, material, design, and function. Additionally, the submission includes reference devices, E-link (K141972) and Biomet E1 (K100048).
Substantial Equivalence:
Bench testing and engineering analyses were performed on subject Klassic® Knee CR/Congruent and Ultra-PS® Tibial Inserts Knee Components with E^X Poly to evaluate wear, tibial-femoral stability characteristics, stress distributions and range of motion and tibial modular disassembly characteristics. The results of these analyses and testing indicate that the subject CR/Congruent and Ultra-PS® Tibial Inserts with E^X Poly are substantially equivalent to the predicate components. The biocompatibility of the subject tibial inserts was evaluated in accordance with FDA's Biocompatibility guidance document. Lastly, the subject tibial inserts are in compliance with LAL testing requirements for orthopedic implants.