(81 days)
No
The 510(k) summary describes a mechanical knee revision system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical testing and engineering analysis.
Yes
The device is a prosthetic replacement system (implants) intended for the treatment of various joint diseases and revision of failed knee surgeries, directly addressing and alleviating medical conditions.
No
This device is a prosthetic implant system (Klassic® Revision System) used for total knee arthroplasty, not for diagnosing medical conditions. The provided information describes its intended use for prosthetic replacement in various joint diseases and its components, and fatigue testing, all of which are related to an implantable device, not a diagnostic one.
No
The device description explicitly lists multiple physical implants and implant materials made of various metals and polymers, indicating it is a hardware-based medical device.
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 surgical implant for prosthetic replacement of the knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The device description lists implants and implant materials used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the mechanical properties and durability of the implant (fatigue, disassembly torque, fixation strength), which are relevant to a surgical device, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Klassic® Revision System is intended for prosthetic replacement in treatment 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® Revision 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, MBH, OIY
Device Description
The Klassic® Revision System is being introduced as a line extension for use with the Klassic® Knee System during total knee arthroplasty. The Klassic® Revision System includes the following implants and implant materials: Klassic® Stem Extension, Femoral, Cemented (Ti6Al4V), Klassic® Stem Adapter, Femoral (Ti6A14V), Klassic® Posterior Femoral Augment (Ti6A14V), Klassic® Distal Femoral Augment (Ti6Al4V), Klassic® Tibial Augment (Ti6Al4V, UHMWPE), Posterior Femoral Augment Set Screw (Ti6A14V), Distal Femoral Augment Set Screw (Ti6A14V), Universal Cone™ with Ti-Coat (Ti6A14V and unalloyed Ti powder).
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
Prescription Use
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
The subject device underwent Knee Femur and Stem Extension construct fatigue testing, and postfatigue torque disassembly strength testing. In addition, engineering analyses were performed to evaluate the augment fixation strength via set screw fixation and cement fixation, fatigue strength of the Universal Cones, and also porous coating characterization. Additionally, the Klassic® Revision System 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 (based on ASTM F1820)
- Post Fatigue Disassembly Torque
- Fretting Corrosion Analysis (per Goldberg Criteria and Fricka, et al.)
- Femoral Augment Fixation via set screw fixation
- Tibial Augment Fixation via cement fixation
- Porous Coating characterization per FDA Guidance document
- Universal Cone Fatigue Strength
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.
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May 19, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding a graphic. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.
Total Joint Othopedics, Inc. % Hollace Rhodes VP. Orthopedic Regulatory Affairs MCRA, LLC. 803 7th Street NW, Floor 3 Washington, District of Columbia 20001
Re: K230537
Trade/Device Name: Klassic® Revision 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, OIY Dated: March 20, 2023 Received: March 21, 2023
Dear Hollace 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.
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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) 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.
Jesse Muir -S
Jesse Muir, PhD Acting 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) K230537
Device Name Klassic® Revision System
Indications for Use (Describe)
The Klassic® Revision System is intended for prosthetic replacement in treatment 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® Revision 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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510(k) Summary
| 510(k) Number: | K230537 | |
|---|---|---|
| Manufacturer: | Total Joint Orthopedics, Inc. | |
| 1567 E. Stratford Avenue | ||
| Salt Lake City, UT 84106 | ||
| Phone: 801.486.6070 | ||
| Contact: | Mr. Chris Weaber | |
| Director of Research and Development | ||
| Prepared By: | MCRA, LLC | |
| 803 7th Street NW, Floor 3 | ||
| Washington, DC 20001 | ||
| Phone: 202.552.5800 | ||
| Date Prepared: | March 20, 2023 | |
| Device Trade Name: | Klassic® Revision System | |
| Device Common Name: | Revision knee replacement system | |
| Classification: | 21 CFR 888.3560 Knee joint patellofemorotibial | |
| polymer/metal/polymer semi-constrained cemented prosthesis | ||
| 21 CFR 888.3565 Knee joint patellofemorotibial | ||
| polymer/metal/polymer semi-constrained uncemented prosthesis | ||
| Class II | ||
| Product Code: | IWH, MBH, 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 .
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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.
Device Description:
The Klassic® Revision System is being introduced as a line extension for use with the Klassic® Knee System during total knee arthroplasty. The Klassic® Revision System includes the following implants and implant materials: Klassic® Stem Extension, Femoral, Cemented (Ti6Al4V), Klassic® Stem Adapter, Femoral (Ti6A14V), Klassic® Posterior Femoral Augment (Ti6A14V), Klassic® Distal Femoral Augment (Ti6Al4V), Klassic® Tibial Augment (Ti6Al4V, UHMWPE), Posterior Femoral Augment Set Screw (Ti6A14V), Distal Femoral Augment Set Screw (Ti6A14V), Universal Cone™ with Ti-Coat (Ti6A14V and unalloyed Ti powder).
Predicate Devices:
The modified Klassic® System is substantially equivalent to the primary predicate Klassic® Knee System (K112906, K140942) with respect to design and indications for use. The modified Klassic® Knee System is also substantially equivalent to the Stryker Triathlon (K070095) with regards to material, function, and indications for use.
Comparison of Technological Characteristics:
The modified Klassic® Knee System features the same materials (Ti6Al4V per ASTM F136 and UHMWPE per ASTM F648 and Ti-Coat per ASTM F67 or F1580), same use in primary or revision Total Knee Arthroplasty, and same gamma sterilization compared to the predicate Klassic® Knee System (K112906, K183596, K140942).
Discussion of Non-Clinical Testing/Performance Data:
The subject device underwent Knee Femur and Stem Extension construct fatigue testing, and postfatigue torque disassembly strength testing. In addition, engineering analyses were performed to evaluate the augment fixation strength via set screw fixation and cement fixation, fatigue strength of the Universal Cones, and also porous coating characterization. Additionally, the Klassic® Revision System 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 (based on ASTM F1820)
- Post Fatigue Disassembly Torque
- Fretting Corrosion Analysis (per Goldberg Criteria and Fricka, et al.) ●
- Femoral Augment Fixation via set screw fixation
- Tibial Augment Fixation via cement fixation
- . Porous Coating characterization per FDA Guidance document
- Universal Cone Fatigue Strength
Conclusion:
Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Bench Testing Summary, demonstrating that the subject
5
components perform as safe and effective compared to the predicate components, and is substantially equivalent to the predicate.