(28 days)
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No
The document describes a mechanical knee implant component and its intended use, with no mention of AI or ML technology in its design, function, or performance evaluation.
Yes.
The device is intended for prosthetic replacement to treat various joint diseases and correct deformities, which is a therapeutic purpose.
No
Explanation: The device, the Klassic™ Knee System and Sombrero Patella component, is described as intended for prosthetic replacement in total knee replacement procedures, addressing various joint diseases and surgical failures. Its purpose is to replace a joint, not to diagnose a condition. The summary of performance studies also describes engineering analyses of contact stress and mechanical strength, not diagnostic capabilities.
No
The device description explicitly states the component is manufactured from ultrahigh molecular weight polyethylene, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a prosthetic replacement for the knee joint to treat various conditions. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical component (patella) made of polyethylene, designed to be implanted in the knee.
- 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 analysis.
This device falls under the category of a surgical implant or prosthetic device.
N/A
Intended Use / Indications for Use
The Klassic™ Knee System is intended for prosthetic replacement with the use of bone cement 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
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Sombrero Patella component will be used in conjunction with the Klassic Knee System during total knee replacement. The component is manufactured from ultrahigh molecular weight polyethylene in four diameters and two thicknesses.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical Testing:
Engineering analyses were performed on the TIO Sombrero Patella and the previously cleared TJO Domed Patella to evaluate their contact stress and mechanical strength. The results of these analyses indicate that the Sombrero Patella is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Klassic Knee Domed Patella (K112906), Zimmer Natural Knee All Polyethylene Patella (K934695)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a way that suggests unity and connection. The profiles are black and are set against a white background. Encircling the profiles are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 17, 2015
Total Joint Orthopedics, Incorporated Mr. Chris Weaber Manufacturing Development Engineer 1567 East Stratford Avenue Salt Lake City, Utah 84106
Re: K150105
Trade/Device Name: Klassic Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: January 19, 2015 Received: January 20, 2015
Dear Mr. 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
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Page 2 - Mr. Chris Weaber
(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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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4. Indications for Use
510(k) Number (if known): K150105
Device Name: Klassic Knee System
The Klassic™ Knee System is intended for prosthetic replacement with the use of bone cement 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
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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1. 510(k) Summary
| Device Trade Name: | Klassic™ Knee System |
|---|---|
| Manufacturer: | Total Joint Orthopedics, Inc. |
| 1567 E. Stratford Avenue | |
| Salt Lake City, UT 84106 | |
| Contact: | Mr. Chris Weaber |
| Manufacturing Development Engineer | |
| 1567 East Stratford Ave. | |
| Salt Lake City, Utah 84106 | |
| Phone: 801.486.6070 | |
| Fax: 801.486.6117 | |
| cweaber@tjoinc.com | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: 202.552.5800 | |
| Fax: 202.552.5798 | |
| Date Prepared: | January 19, 2015 |
| Classification: | 21 CFR 888.3560, Knee joint patellofemorotibial |
| polymer/metal/polymer semi-constrained cemented prosthesis | |
| Class: | II |
| Product Code: | IWH |
Indications for Use:
The Klassic™ Knee System is intended for prosthetic replacement with the use of bone cement 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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Device Description:
The Sombrero Patella component will be used in conjunction with the Klassic Knee System during total knee replacement. The component is manufactured from ultrahigh molecular weight polyethylene in four diameters and two thicknesses.
Predicate Devices:
The Sombrero Patella is substantially equivalent to the primary predicate Klassic Knee Domed Patella (K112906) with respect to its intended use, material, geometry, and method of fixation. The Sombrero Patella is also substantially equivalent to the Zimmer Natural Knee All Polyethylene Patella (K934695) with respect to intended use, geometry and method of fixation. The information summarized in the Design Control Activities Summary demonstrates that the Sombrero Patella met the pre-determined acceptance criteria for the verification activities.
Preclinical Testing:
Engineering analyses were performed on the TIO Sombrero Patella and the previously cleared TJO Domed Patella to evaluate their contact stress and mechanical strength. The results of these analyses indicate that the Sombrero Patella is substantially equivalent to the predicate devices.