(30 days)
Not Found
No
The summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a knee implant used to treat various conditions like arthritis and avascular necrosis, which directly addresses a disease or condition in a patient.
No
The device description indicates that the TC-PLUS™ Porous Femoral Component is a surface replacement intended for use in total knee arthroplasty, not for diagnosing medical conditions.
No
The device description clearly describes a physical femoral component (a hardware implant) used in knee arthroplasty, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The TC-PLUS™ Porous Femoral Component is a surgical implant intended for use in total knee replacement surgery. It is a physical component that is placed inside the body.
- Intended Use: The intended use describes the treatment of conditions like arthritis and deformities by replacing the femoral component of the knee joint. This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided clearly describes a medical device used for surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Femoral Condyle
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)
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.
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.
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
K01/1258
MAY 2 4 2001
Appendix V
SUMMARY
OF
SAFETY AND EFFECTIVENESS INFORMATION
1
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.
3
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.
4
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
5
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