(59 days)
No
The summary describes a traditional knee replacement system and does not mention any AI or ML components or functionalities.
Yes.
The device is a prosthetic replacement for the knee joint, which would be used to treat conditions like osteoarthritis and rheumatoid arthritis, restoring function and alleviating pain.
No
The device, Klassic® Knee System, is a total knee joint replacement system, which is a prosthetic replacement for knees, not a device used to diagnose medical conditions.
No
The device description clearly states it is a "cemented total knee joint replacement system comprised of modular components" made of "ultrahigh molecular weight polyethylene (UHMWPE)", indicating it is a physical implant, not software.
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 patient conditions. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a cemented total knee joint replacement system comprised of modular components made of UHMWPE. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
Therefore, the Klassic® Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Klassic® Knee System is intended for prosthetic replacement with the use of bone cement 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
Product codes
JWH
Device Description
The Klassic® Knee System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to add All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® to the Klassic Knee System. These components are manufactured with ultrahigh molecular weight polyethylene (UHMWPE). The CR/Congruent and Ultra-PS® A11-Poly Tibias are available in sizes to match various patient anatomies.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analyses were performed on All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® to evaluate their contact area and surface stress, overall strength, and cement fixation features. The results of these analyses indicate that the All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® are substantially equivalent to the predicate components. Additionally, the All-Poly Tibias have undergone LAL testing and are in compliance with requirements for orthopedic implants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112906, K140942, K150105, K153075, K153310
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human face or head in profile, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2016
Total Joint Orthopedics, Inc. Mr. Chris Weaber Product Development, Regulatory Manager 1567 E. Stratford Avenue Salt Lake City, Utah 84106
Re: K162422
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: September 30, 2016 Received: September 30, 2016
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 (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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/ResourcesforYou/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,
Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a large, sans-serif font. The text is black and appears to be centered. The background is a light color, possibly white or light gray.
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
510(k) Number (if known)
K162422
Device Name Klassic® Knee System
Indications for Use (Describe)
The Klassic Knee System is intended for prosthetic replacement with the use of bone cement 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
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
| 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
Product Development, Regulatory Manager |
| 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: | August 29, 2016 |
| Device Trade Name: | Klassic® Knee System |
| Device Common Name: | Total knee replacement system |
| Classification: | 21 CFR 888.3560 – Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
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
4
Device Description:
The Klassic® Knee System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to add All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® to the Klassic Knee System. These components are manufactured with ultrahigh molecular weight polyethylene (UHMWPE). The CR/Congruent and Ultra-PS® A11-Poly Tibias are available in sizes to match various patient anatomies.
Predicate Devices:
The modified Klassic Knee System is substantially equivalent to the predicate Klassic Knee System (K112906, K140942, K150105, K153075, and K153310) and the Natural Knee II All-Poly Tibia (K936159) with respect to indications, design, and function. The information summarized in the Design Control Activities Summary demonstrates that the subject All-Poly Tibias met the pre-determined acceptance criteria for the verification activities.
Substantial Equivalence:
Engineering analyses were performed on All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® to evaluate their contact area and surface stress, overall strength, and cement fixation features. The results of these analyses indicate that the All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® are substantially equivalent to the predicate components. Additionally, the All-Poly Tibias have undergone LAL testing and are in compliance with requirements for orthopedic implants.