(49 days)
The Klassic® Knee System is intended for prosthetic replacement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJ): . 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.
The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts with E-Link®, Ultra-PS® Tibial Inserts with E-Link®, Sombrero Patellae with E-Link® and Domed Patellae with E-Link® ("E-Link® Knee Components") to the Klassic® Knee System. These components are manufactured from E-link®, a Vitamin E blended UHMWPE crosslinked by gamma irradiation. The E-Link® Knee Components are available in various sizes and thicknesses to match patient anatomy.
The provided text is a 510(k) summary for the Klassic® Knee System. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML-enabled device. The document is for a traditional medical device (knee replacement system) and focuses on substantial equivalence based on engineering analyses and bench testing, rather than performance metrics related to diagnostic or predictive accuracy.
Therefore, I cannot provide the requested information. The document does not describe any AI/ML model.
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March 9, 2018
Total Joint Orthopedics, Inc. Chris Weaber Product Development, Regulatory Manager 1567 E. Stratford Avenue Salt Lake City, Utah 84106
Re: K180159
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, MBH Dated: January 19, 2018 Received: January 19, 2018
Dear Chris 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K180159
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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5. 510(k) Summary
| Manufacturer: | Total Joint Orthopedics, Inc.1567 E. Stratford AvenueSalt Lake City, UT 84106Phone: 801.486.6070Fax: 801.486.6117 | |
|---|---|---|
| Contact: | Mr. Chris WeaberProduct Development, Regulatory Manager | |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC1050 K Street, NW, Suite 1000Washington, DC 20001Phone: 202.552.5800 | |
| Date Prepared: | January 19, 2018 | |
| Device Trade Name: | Klassic® Knee System | |
| Device Common Name: | Tibial Inserts and Patellae | |
| Classification: | 21 CFR 888.3560 – Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented21 CFR 888.3565 Knee joint patellofemorotibialmetal/polymer porous-coated uncemented prosthesisClass II | |
| Product Codes: | JWH, 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 (NIDJ): . 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
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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.
Device Description:
The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts with E-Link®, Ultra-PS® Tibial Inserts with E-Link®, Sombrero Patellae with E-Link® and Domed Patellae with E-Link® ("E-Link® Knee Components") to the Klassic® Knee System. These components are manufactured from E-link®, a Vitamin E blended UHMWPE crosslinked by gamma irradiation. The E-Link® Knee Components are available in various sizes and thicknesses to match patient anatomy.
Predicate Devices:
The E-Link® Knee Components are substantially equivalent to the predicate Klassic® Knee System Components (K112906, K140942, K150105, K153075, K153310, and K162422) with respect to indications, design, and function. The E-Link material is the same as the E-link material used in the Klassic HD® Acetabular Insert with E-Link Poly (K141972) and Pipeline's Vitamin E Poly (K112802).
Substantial Equivalence:
Engineering analyses and bench testing were performed on E-Link® Knee Components to evaluate wear for the worst case E-Link® Knee Construct, tibial-femoral stability characteristics, stress distributions and range of motion and tibial modular disassembly characteristics, as well as patella-femoral resistance to lateral subluxation and surface stress distribution. The results of these analyses and testing indicate that the E-Link® Components are substantially equivalent to the predicate components. Knee Additionally, the E-Link® Knee Components are in compliance with LAL testing requirements for orthopedic implants.
§ 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.