(72 days)
Not Found
No
The summary describes a mechanical knee prosthesis and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The focus is on the physical design, materials, and biomechanical performance.
Yes
The device, a knee prosthesis, is used as a replacement for a damaged knee joint to provide stability and restore function, which directly addresses a medical condition and aims to improve a patient's health.
No
The device described is a knee replacement system, which is a prosthetic device for surgical implantation, not a diagnostic tool. Its purpose is to replace a damaged knee joint, not to diagnose a condition.
No
The device description clearly states it is a "tri-compartmental rotating hinged prosthesis of the total condylar type" consisting of "femoral, tibial and patellar components," which are physical hardware implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "replacement of the knee joint." This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description talks about "femoral, tibial and patellar components," which are parts of a prosthetic knee joint.
- Anatomical Site: The anatomical site is the "Knee joint," indicating it's used directly on the patient's body.
- Performance Studies: The performance studies mentioned are "Biomechanical fatigue tests," which are relevant to the structural integrity of an implant, not the analytical performance of a diagnostic test.
IVD devices are used in vitro (outside the body) to analyze samples like blood, urine, or tissue. The RT-PLUS™ Knee System is an in vivo device (used inside the body) for surgical replacement.
N/A
Intended Use / Indications for Use
The RT-PLUS™ Knee System is a tri-compartmental rotating hinged prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components. It is indicated for use as a replacement of the knee joint in which significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision or connective tissue disorders. The RT-PLUS™ Modular Cemented Knee provides joint stability when any or all of the following structures are non-functional: MCL, LCL, PCL, ACL and the iliotibial band.
Product codes
KRO
Device Description
The RT-PLUS™ Additional Knee Components are identical to the predicate device, except sizes 2 and 10 were added to the existing sizes 4, 6, and 8 of the RT-PLUS™ Knee System.
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)
Biomechanical fatigue tests have been performed on the worst-case model. The test results of the additional components were favorable to the predicate device and are sufficient for in vivo loading.
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
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
SPECIAL 510(K) DEVICE MODIFICATION RT-PLUS Knee Additional Components October 5, 2001
DEC 2 0 2001
KD13340
510(k) Summary of Safety and Effectiveness 510(k) Summary of Safety and Effectiveness
[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
- PLUS ORTHOPEDICS Contact: 6055 Lusk Blvd. San Diego, CA 92121 Tel: 858-550-3800 x 2506 Attn: Mr. Hartmut Loch, RAC Director, Regulatory Affairs
- RT-PLUS™ Knee System Trade name:
Hinged Knee Prosthesis Common name:
Prosthesis Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Classification & 888.3510 - Class II name: Product Code: KRO - 87 Orthopedic Device Panel
RT-PLUS Knee System, S/E May 11, 2001 - K003504 manufactured by Predicate Device: PLUS Endoprothetik AG, Switzerland
The RT-PLUS™ Additional Knee Components are identical to the Device predicate device, except sizes 2 and 10 were added to the existing sizes Modification 4, 6, and 8 of the RT-PLUS™ Knee System. Description:
The RT-PLUS™ Knee System is a tri-compartmental rotating hinged Indications: prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components. It is indicated for use as a replacement of the knee joint in which significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision or connective tissue disorders. The RT-PLUS™ Modular Cemented Knee provides joint stability when any or all of the following structures are nonfunctional: MCL, LCL, PCL, ACL and the iliotibial band.
Contraindications include acute or chronic infections (local or systemic), Contraindications: 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.
Biomechanical fatigue tests have been performed on the worst-case Performance model. The test results of the additional components were favorable to data: the predicate device and are sufficient for in vivo loading.
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1
Image /page/1/Picture/12 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. Inside the circle is a stylized image of three overlapping, curved shapes that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hartmut Loch, RAC Director, Regulatory Affairs PLUS Orthopedics 6055 Lusk Boulevard San Diego, CA 92121-2700
DEC 2 0 2001
Re: K013340
Trade/Device Name: RT-PLUS" Hinged Knee Regulation Number: 21 CFR §888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: November 16, 2001 Received: November 20, 2001
Dear Mr. Loch:
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 with the providions of the approval application (PMA). You may, therefore, market the approval or a promance apple on and provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, provisions facturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations (I writ), it may be bactor be found in the Code of Federal Regulations, Title 21, Parts arround your 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 r lease on 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 I coderal agencies: "Foundsiveing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions
2
Page 2 – Mr. Hartmut Loch
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maxioning your antial equivalence of your device to a legally premarket notification. The IDA inding of subscribed on of a market of your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and if you desire specific advice for your dovice diagnostic devices), please contact the Office of additionally 21 CFC Part 807.10 for mi 120 c.m. 1120 c.m. 112 promotion and advertising of Compliance at (301) 394-6057. Tidnitionship to questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division (800) Other general information on your respend and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address 036-2011 or (9) fda gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
3
SPECIAL 510(K) DEVICE MODIFICATION RT-PLUS Knee Additional Components October 5, 2001
Page 1
510(k) Number:
Device Name(s):
RT-PLUS Knee Additional Components
Indications for Use:
The RT-PLUS™ Knee System is a tri-compartmental rotating hinged prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components. It is indicated for use as a replacement of the knee joint in which significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision or connective tissue disorders. The RT-PLUS™ Modular Cemented Knee provides joint stability when any or all of the following structures are non-functional: MCL, LCL, PCL, ACL and the iliotibial band.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of General, Restorative and Neurological Devices |
| 510(k) Number | K013340 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The-Counter-Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional format 1-2-96) |