(98 days)
Not Found
No
The summary describes a traditional 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 medical devices. The performance studies focus on mechanical and material properties.
Yes
The device is a prosthetic replacement for the knee joint, intended to treat conditions like degenerative joint disease and inflammatory joint disease, which are therapeutic interventions.
No
Explanation: This device, the Klassic® Knee System, is a prosthetic replacement for the knee joint. Its intended use is to replace affected parts of the knee in patients with various joint diseases or failed previous surgeries. It is an implantable device used for surgical treatment, not for diagnosing conditions.
No
The device description clearly states it is a "Klassic® Knee System" which includes femoral and tibial components, indicating physical implants, not software. The performance studies also describe engineering analysis and testing of physical components like pegs, inserts, and the femur/tibial components.
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 address various conditions like osteoarthritis, rheumatoid arthritis, and failed previous surgeries. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details components of a knee replacement system (femoral and tibial components, inserts, pegs). These are physical implants designed to be surgically placed within the body.
- 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.
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 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, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
Device Description
The Klassic® Knee System employs prostheses designed to help surgeons restore knee joint biomechanics intra-operatively. The purpose of this 510(k) is to add the posterior stabilizing Klassic® Knee Femur, PS-Post; Klassic Femoral Pegs; and the Klassic® Tibial Insert, PS-Post with Standard Poly; and the Klassic® Tibial Insert, PS-Post with E-Link® Poly; to the Klassic Knee System. The subject femoral and tibial components are available in various sizes and thicknesses to match patient anatomy.
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 analysis and testing included Modular Peg Strength Analysis, Femoral/Tibial Insert Stability Characteristics and Femur/Tibial Insert Contact Stress Evaluation, Range of Motion, Knee Simulator Wear, Tibial Insert Post Fatigue, Tibial Insert Modular Disassembly, Patella/Femoral Subluxation and Patella/Femoral Surface Stress. All results met the predetermined acceptance criteria and demonstrate that the modified Klassic Knee System is substantially equivalent to the identified legally marketed predicate devices. Additionally, the Klassic® Knee System is in compliance with LAL testing requirements for orthopedic implants per AAMI ST-72 testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K112906, K140942, K150105, K153075, K153310, K162422, K180159
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.
Not Found
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).
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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA (U.S. Food & Drug Administration) logo.
March 29, 2019
Total Joint Orthopedics, Inc. Chris Weaber Product Development, Regulatory Manager 1567 E. Stratford Avenue Salt Lake City, Utah 84106
Re: K183596
Trade/Device Name: Klassic Knee System - Klassic Knee PS-Post Femur: Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, 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 Dated: December 21, 2018 Received: December 21, 2018
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
1
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).
Sincerely,
Peter G. Allen -S
Digitally signed by Peter G. Allen -S Date: 2019.03.29 17:00:22 -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) K183596
Device Name Klassic® Knee System
Indications for Use (Describe)
The Klassic® Knee System is intended for prosthetic replacement 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, Porous, and the Klassic Tibial Baseplate, Porous, 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
Fax: 801.486.6117 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Chris Weaber
Product Development, Regulatory Manager |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K Street, NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5800
Fax: 202.552.5798 |
| Date Prepared: | December 21, 2018 |
| Device Trade Name: | Klassic® Knee System - Klassic Knee PS-Post Femur;
Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee
Tibial Insert, PS-Post, E-Link Poly |
| Common Name: | PS Femur, PS Inserts |
| Classifications: | 21 CFR 888.3560 – Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
21 CFR 888.3565 - Knee joint patellofemorotibial metal/
polymer porous-coated uncemented prosthesis
Class II |
| Product Codes: | JWH, MBH |
Indications for Use:
The Klassic® Knee System is intended for prosthetic replacement in treatment of the following:
- o 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, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
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Device Description:
The Klassic® Knee System employs prostheses designed to help surgeons restore knee joint biomechanics intra-operatively. The purpose of this 510(k) is to add the posterior stabilizing Klassic® Knee Femur, PS-Post; Klassic Femoral Pegs; and the Klassic® Tibial Insert, PS-Post with Standard Poly; and the Klassic® Tibial Insert, PS-Post with E-Link® Poly; to the Klassic Knee System. The subject femoral and tibial components are available in various sizes and thicknesses to match patient anatomy.
Predicate Devices:
The modified Klassic® Knee System is substantially equivalent to the predicate Klassic® Knee System (K112906), Klassic® Knee System-Tibial Stem Extensions (K140942), Klassic® Knee Sombrero Patella (K150105), Klassic® Knee System - Tibial Inserts, 18mm (K153075), Klassic® Knee System - Femur, Nonporous size 7 (K153310), Klassic® Knee System All Poly Tibia (K162422), and Klassic® Knee System Tibial Inserts with E-Link® Poly (K180159) with respect to indications, design, material and function.
Substantial Equivalence:
Engineering analysis and testing included Modular Peg Strength Analysis, Femoral/Tibial Insert Stability Characteristics and Femur/Tibial Insert Contact Stress Evaluation, Range of Motion, Knee Simulator Wear, Tibial Insert Post Fatigue, Tibial Insert Modular Disassembly, Patella/Femoral Subluxation and Patella/Femoral Surface Stress. All results met the predetermined acceptance criteria and demonstrate that the modified Klassic Knee System is substantially equivalent to the identified legally marketed predicate devices. Additionally, the Klassic® Knee System is in compliance with LAL testing requirements for orthopedic implants per AAMI ST-72 testing.