(35 days)
Not Found
No
The 510(k) summary describes a knee implant system and its components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance studies focus on engineering analyses of the physical components.
No.
The device is a prosthetic replacement for the knee joint, which is a restorative device, not a therapeutic one. It's intended to replace a damaged body part rather than to treat a disease or condition directly.
No
The device is a prosthetic replacement (Klassic Knee System components) used for total knee replacement, which is a treatment, not a diagnostic procedure.
No
The device description clearly states it is adding physical components (Sombrero Patella) made of polyethylene, which are hardware.
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 for the knee joint to treat various conditions. This is a surgical implant, not a test performed on samples from the human body.
- Device Description: The device is described as components for a total knee replacement system, made from materials like polyethylene. This aligns with a physical implant, not a diagnostic test.
- 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 and its components are medical devices intended for surgical implantation, not in vitro diagnostic use.
N/A
Intended Use / 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 (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 Knee System is indicated for cemented use only, except for the Klassic Femur with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®. which are indicated for cementless use.
Product codes
JWH, MBH, OIY
Device Description
The purpose of this 510(k) is to add size 5, 10mm Sombrero Patella components in Standard Poly and E-Link Poly to be used in conjunction with the Klassic® Knee System during total knee replacement. The components are manufactured from ultrahigh molecular weight polyethylene or Vitamin E blended ultrahigh molecular weight polyethylene with a 40mm diameter and 10mm thickness.
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 (Part 21 CFR 801 Subpart D)
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 the subject size 5, 10mm Sombrero Patellae to evaluate their conformance, contact area and contact stress, mechanical strength, and peg geometry. The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae. Additionally, the subject components are in compliance with LAL testing requirements for orthopedic implants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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Total Joint Orthopedics, Inc. Chris Weaber Product Development, Regulatory Manager 1567 East Stratford Avenue Salt Lake City, Utah 84106
March 15, 2019
Re: K190280
Trade/Device Name: Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly 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: February 8, 2019 Received: February 8, 2019
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. 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.
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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).
Sincerelv.
Daniel S. Ramsey -S 2019.03.15 11:38:59 -04'00'
FOR 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) K190280
Device Name Klassic® Knee System
Indications for Use (Describe)
The Klassic Knee 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 Knee System is indicated for cemented use only, except for the Klassic Femur with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®. 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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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
Product Development, Regulatory Manager | | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K Street, Suite 1000
Washington, DC 20001
Phone: 202.552.5800 | | |
| Date Prepared: | February 8, 2019 | | |
| Device Trade Name: | Klassic® Knee System | | |
| Device Common Name: | Polyethylene Patella Component | | |
| 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 porous coated uncemented prosthesis | | |
| Class: | II | | |
| Product Codes: | JWH, 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 (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 with Cobalt 3DTM, and the Klassic Tibial Baseplate with Ti-Coat®, which are indicated for cementless use.
Device Description:
The purpose of this 510(k) is to add size 5, 10mm Sombrero Patella components in Standard Poly and E-Link Poly to be used in conjunction with the Klassic® Knee System during total knee replacement. The components are manufactured from ultrahigh molecular weight polyethylene or Vitamin E blended ultrahigh molecular weight polyethylene with a 40mm diameter and 10mm thickness.
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TJO Klassic® Knee System – Special 510(k)
Predicate Devices:
The subject size 5, 10mm Sombrero Patella implants are substantially equivalent to the predicate size 1-4 Sombrero Patellae (K150105 & K180159) with respect to their intended use, material, geometry, and method of fixation. The information summarized in the Design Control Activities Summary demonstrates that the subject size 5, 10mm Sombrero Patellae met the pre-determined acceptance criteria for the verification activities.
Substantial Equivalence:
Engineering analyses were performed on the subject size 5, 10mm Sombrero Patellae to evaluate their conformance, contact area and contact stress, mechanical strength, and peg geometry. The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae. Additionally, the subject components are in compliance with LAL testing requirements for orthopedic implants.