(88 days)
Not Found
No
The summary describes a knee implant system and its mechanical testing, with no mention of AI or ML.
No.
The device is a prosthetic replacement for the knee joint, which is a restorative rather than a therapeutic function.
No
This device is a prosthetic knee system intended for surgical replacement of the knee joint. Its purpose is to treat various knee conditions and is not designed to diagnose them.
No
The device description and performance studies clearly indicate this is a physical implant (Tibial Baseplate) and not a software-only device. The testing described relates to material properties and mechanical performance.
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 Tibial Baseplate, a component of a knee replacement system.
- 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 in vitro testing.
- Performance Studies: The performance studies focus on mechanical properties and safety of the implant (fatigue testing, LAL testing, MRI safety), which are relevant to a surgical device, not an IVD.
In summary, the Klassic® Knee System is a surgical implant used for joint replacement, not a device used to perform diagnostic tests outside of the body.
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 (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, with Cobalt 3D®, the Klassic Tibial Baseplate with Ti-Coat®, and the Universal™ Cones with Ti-Coat® which are also indicated for cementless use.
Product codes
JWH, OIY
Device Description
The Klassic® Tibial Baseplate, Revision (Ti6Al4V) is being introduced as a line extension for use with the Klassic® Knee System during total knee arthroplasty.
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
Non-Clinical Testing/Performance Data: The subject device underwent Tibial Baseplate Fatigue Testing based on ASTM F1800. Additionally, the Klassic® Tibial Baseplate, Revision is in compliance with LAL testing requirements for orthopedic implants.
Non-clinical testing and engineering analysis conducted to demonstrate substantial equivalence was as follows:
- Fatigue Analysis (ASTM F3334-19)
- Modular Interface Fatigue testing (based on ASTM F1800)
- Post Fatigue Disassembly Torque (internal protocol)
- Fretting Corrosion Analysis (per Goldberg Criteria and Fricka, et al.)
- Femoral Augment Fixation via set screw and cement fixation
- Tibial Augment Fixation via set screw and cement fixation
- MRI Safety Testing per ASTM F2052-21, ASTM F2213-17, ASTM F2182-19e2
Conclusion: Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities, demonstrating that the subject component performs as safe and effective compared to the predicate components, and is substantially equivalent to the predicate.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
March, 24, 2025
Total Joint Othopedics, Inc. % Chris Weaber Consultant Arthroplasty Regulatory Consulting 1433 E. Mulberry Way Sandy, Utah 84093
Re: K243991
Trade/Device Name: Klassic Knee System - Revision Tibial Baseplate 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: December 24, 2024 Received: December 26, 2024
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory
2
assistance/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,
Digitally signed by Peter G. Peter G. Allen -S Date: 2025.03.24 11:35:27
for Lixin Liu, 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
3
Indications for Use
510(k) Number (if known) K243991
Device Name
Klassic Knee System - Revision Tibial Baseplate
| 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, with Cobalt 3D®, the Klassic Tibial Baseplate with Ti-Coat®, and the Universal™ Cones with Ti-Coat® which are also 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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K243991 (Page 1 of 2)
510(k) Summary
| Manufacturer: | Total Joint Orthopedics, Inc.
1567 E. Stratford Avenue
Salt Lake City, UT 84106
Phone: 801.486.6070 |
|---------------------|--------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Chris Weaber
Consultant |
| Prepared By: | Chris Weaber
1433 E. Mulberry Way
Sandy, UT 84093
Phone: 650.922.7326 |
| Date Prepared: | March 10, 2025 |
| Device Trade Name: | Klassic Knee System - Revision Tibial Baseplate |
| Device Common Name: | Revision Baseplate |
| Classification: | 21 CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented prosthesis |
| | Class II |
| Product Code: | 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, with Cobalt 3D®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones™ with Ti-Coat®, which are also indicated for cementless use.
5
Device Description:
The Klassic® Tibial Baseplate, Revision (Ti6Al4V) is being introduced as a line extension for use with the Klassic® Knee System during total knee arthroplasty.
Predicate Devices:
The modified Klassic® Tibial Baseplate. Revision is substantially equivalent to the primary predicate Klassic® Tibial Baseplate (K112906, K230537) with respect to design and function and indications for use.
Comparison of Technological Characteristics:
The modified Klassic® Tibial Baseplate, Revision features the same material (Ti6Al4V per ASTM F136) same use in primary or revision Total Knee Arthroplasty, and same gamma sterilization compared to the predicate Klassic® Knee System (K112906, K230537).
Discussion of Non-Clinical Testing/Performance Data:
The subject device underwent Tibial Baseplate Fatigue Testing based on ASTM F1800. Additionally, the Klassic® Tibial Baseplate, Revision is in compliance with LAL testing requirements for orthopedic implants.
Non-clinical testing and engineering analysis conducted to demonstrate substantial equivalence was as follows:
- Fatigue Analysis (ASTM F3334-19)
- Modular Interface Fatigue testing (based on ASTM F1800) ●
- Post Fatigue Disassembly Torque (internal protocol)
- Fretting Corrosion Analysis (per Goldberg Criteria and Fricka, et al.) ●
- Femoral Augment Fixation via set screw and cement fixation
- Tibial Augment Fixation via set screw and cement fixation
- MRI Safety Testing per ASTM F2052-21, ASTM F2213-17, ASTM F2182-19e2 ●
Conclusion:
Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities, demonstrating that the subject component performs as safe and effective compared to the predicate components, and is substantially equivalent to the predicate.