(21 days)
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 (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 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 18mm Ultra-PS and 18mm CR/Congruent tibial inserts to the Klassic™ Knee System. These components are manufactured from ultrahigh molecular weight polyethylene and each is available in 6 sizes.
This 510(k) pertains to adding new tibial inserts (18mm Ultra-PS and 18mm CR/Congruent) to an existing Klassic™ Knee System. The document focuses on demonstrating that these new components are substantially equivalent to the previously cleared components and meet the required performance criteria. Therefore, the information provided isn't a typical study demonstrating a device's clinical performance, but rather an engineering evaluation for new component additions.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The information summarized in the Design Control Activities Summary demonstrates that the 18mm Ultra-PS and 18mm CR/Congruent tibial insert met the pre-determined acceptance criteria for the verification activities." However, the specific acceptance criteria and detailed performance results are not provided in this summary document. The summary only generally states that engineering analyses were performed to evaluate "resistance to modular disassembly and stability characteristics."
| Acceptance Criteria (Not Detailed) | Reported Device Performance (Not Detailed) |
|---|---|
| Resistance to modular disassembly criteria (Specific values not provided) | Met pre-determined acceptance criteria |
| Stability characteristics criteria (Specific values not provided) | Met pre-determined acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "engineering analyses" performed on the new tibial inserts. This implies a laboratory-based, in-vitro testing scenario, not a study involving human subjects or real-world clinical data.
- Sample Size for Test Set: Not explicitly stated as a numerical value for "samples". It refers to "the 18mm Ultra-PS and 18mm CR/Congruent tibial inserts" and "the previously cleared tibial inserts." This suggests that the analyses were performed on representative physical components or their digital models.
- Data Provenance: Not applicable in the context of clinical data. The analyses are engineering-based, likely performed in a controlled laboratory environment by the manufacturer or a contracted lab. The document does not specify a country of origin for the data beyond the manufacturer's location in Salt Lake City, UT, USA.
- Retrospective or Prospective: Not applicable as this is an engineering analysis, not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth in this context would be defined by engineering specifications, material properties, and biomechanical principles, not expert clinical consensus.
- Qualifications of Experts: Not applicable. The analyses are based on engineering principles.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is an engineering verification, not a clinical study requiring adjudication of observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This is not a clinical imaging or diagnostic device requiring an MRMC study. It's an orthopedic implant.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is a physical orthopedic implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications, material science principles, biomechanical testing standards, and previously established performance benchmarks for the predicate devices. The "ground truth" is defined by the physical and mechanical properties required for a safe and effective knee implant component.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no mention of machine learning or an "algorithm" being trained in this 510(k). The evaluation is based on engineering analyses of physical components.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned in this context.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2015
Total Joint Orthopedics, Incorporated Mr. Chris Weaber Manufacturing Development Engineer 1567 East Stratford Avenue Salt Lake City, Utah 84106
Re: K153075 Trade/Device Name: Klassic™ Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 22, 2015 Received: October 26, 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 (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
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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 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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153075
Device Name Klassic™ Knee System
Indications for Use (Describe)
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 (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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5. 510(k) Summary
| Manufacturer: | Total Joint Orthopedics, Inc.1567 E. Stratford AvenueSalt Lake City, UT 84106Phone: 801.486.6070Fax: 801.486.6117 |
|---|---|
| Contact: | Mr. Chris WeaberManufacturing Development Engineer |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street, NW, 12th FloorWashington, DC 20005Phone: 202.552.5800Fax: 202.552.5798 |
| Date Prepared: | October 22, 2015 |
| Device Trade Name: | Klassic™ Knee System |
| Device Common Name: | Total knee replacement system |
| Classification: | 21 CFR 888.3560 – Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented |
| Class II | |
| Product Code: | JWH |
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 ●
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
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this Special 510(k) is to add 18mm Ultra-PS and 18mm CR/Congruent tibial inserts to the Klassic™ Knee System. These components are manufactured from ultrahigh molecular weight polyethylene and each is available in 6 sizes.
Predicate Devices:
The modified Klassic™ Knee System is substantially equivalent to the predicate Klassic™ Knee System (K112906) with respect to indications, design, and function. The information summarized in the Design Control Activities Summary demonstrates that the 18mm Ultra-PS and 18mm CR/Congruent tibial insert met the pre-determined acceptance criteria for the verification activities.
Substantial Equivalence:
Engineering analyses were performed on the 18mm Ultra-PS and 18mm CR/Congruent tibial inserts and the previously cleared tibial inserts to evaluate their resistance to modular disassembly and stability characteristics. The results of these analyses indicate that the 18mm Ultra-PS and 18mm CR/Congruent tibial inserts are substantially equivalent to the predicate components.
§ 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.