(30 days)
The TC-PLUS™ Porous Femoral Component is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for degenerative, posttraumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patellofemoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery.
The TC-PLUS™ Porous Femoral Components are identical to the predicate device, except that they are Ti-Plasma coated on the underside. They are identical in indications for use, geometry, material, and surface characteristics to the predicate device, and they are intended for use only with bone cement. These additional porous coated femoral components are available in right and left, sizes 2, 4, 6, 8, 10, and 12. The tibial components as well as the tibial PE inserts have not been changed and are identical to the predicate device.
The provided text describes a 510(k) summary for the TC-PLUS™ Porous Femoral Components, a knee prosthesis modification. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biomechanical Equivalence | Sufficient for in vivo loading; equivalent to predicate device. | "Biomechanical tests have been performed. The test results are included in this submission and show that the additional components were equivalent to the predicate device and are sufficient for in vivo loading." |
| Material/Design Equivalence | Identical in indications for use, geometry, material, and surface characteristics (except for porous coating). Intended for use only with bone cement. | "The TC-PLUS™ Porous Femoral Components are identical to the predicate device, except that they are Ti-Plasma coated on the underside. They are identical in indications for use, geometry, material, and surface characteristics to the predicate device, and they are intended for use only with bone cement." |
| Tibial Component/PE Insert Equivalence | No changes from the predicate device. | "The tibial components as well as the tibial PE inserts have not been changed and are identical to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that "Biomechanical tests have been performed," but it does not specify the sample size for these tests.
It also does not mention the country of origin of the data or whether the study was retrospective or prospective. The tests are described as biomechanical, implying a laboratory setting rather than human subject data for this specific submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not refer to "experts" or "ground truth" in the context of establishing performance for the biomechanical tests. The performance criteria were based on equivalence to a predicate device and engineering standards for in vivo loading. This type of submission (modification of an existing device) typically relies on engineering and material science expertise rather than clinical expert consensus for the initial bench testing.
4. Adjudication Method for the Test Set:
This information is not applicable to biomechanical testing where objective measurements are taken rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This information is not applicable. The device is a knee prosthesis, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI would have been conducted or reported for this type of medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used:
For the biomechanical tests, the "ground truth" would be established by engineering specifications, material properties, and established biomechanical standards for knee prostheses. The goal was to prove the modified component was "equivalent to the predicate device and are sufficient for in vivo loading," which implies meeting predefined performance benchmarks in a lab setting.
8. The Sample Size for the Training Set:
This information is not applicable. As a physical medical implant, there would be no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
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K01/1258
MAY 2 4 2001
Appendix V
SUMMARY
OF
SAFETY AND EFFECTIVENESS INFORMATION
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K011 258
PAGE 1 OF 2
510(k) Summary of Safety and Effectiveness
[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
Contact:
Mr. Hartmut Loch, RAC Director, Regulatory Affairs Plus ORTHOPEDICS 6055 Lusk Blvd. San Diego, CA 92121-2700 Tel: 858.550.3800
TC-PLUS™ Porous Femoral Components Trade Name:
Cemented Knee Prosthesis Common Name:
Prosthesis Knee, Patelllofemorotibial, Semi-Constrained, Cemented, Classification Polymer/Metal/Polymer Name:
21 CFR 888.3560 Classification
Number:
Class II Device Class:
87 Orthopedic Devices Panel Classification
Panel:
Product Code: JWH
TC-PLUS® Solution Knee System, which was cleared for marketing in Predicate Device: the U.S.A. by FDA (K000666 S/E 10/13/2000) and is also manufactured by PLUS Endoprothetik AG, Switzerland
Device Modification Description:
The TC-PLUS™ Porous Femoral Components are identical to the predicate device, except that they are Ti-Plasma coated on the underside. They are identical in indications for use, geometry, material, and surface characteristics to the predicate device, and they are intended for use only with bone cement. These additional porous coated femoral components are available in right and left, sizes 2, 4, 6, 8, 10, and 12.
The tibial components as well as the tibial PE inserts have not been changed and are identical to the predicate device.
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PAGE 2 OF 2
Indications:
The TC-PLUS™ Porous Femoral Component is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for degenerative, post-traumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgerv.
Contraindications:
Contraindications include acute or chronic infections (local or systemic), serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.
Performance data:
Biomechanical tests have been performed. The test results are included in this submission and show that the additional components were equivalent to the predicate device and are sufficient for in vivo loading.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2001
Mr. Hartmut Loch Director, Regulatory Affairs Plus Orthopedics 6055 Lusk Boulevard San Diego, California 92121
Re: K011258
Trade Name: TC-PLUS™ Porous Femoral Component Regulation Number: 888.3560 Regulatory Class: II Product Code: JWH Dated: April 23, 2001 Received: April 24, 2001
Dear Mr. Loch:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 - Mr. Hartmut Loch
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (2017) 594-1639. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
втирвееттот
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1
510(k) Number: k0 11258
Device Name(s):
TC-PLUS™ Porous Femoral Components
Indications for Use:
The TC-PLUS™ Porous Femoral Component is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for degenerative, posttraumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patellofemoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mihailescu for emu
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number: 011258
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter-Use (Optional format 1-2-96)
6
§ 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.