(28 days)
No
The summary describes a mechanical knee prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a knee replacement system used to treat significant bone loss and ligamentous deficiencies, which are conditions that impair normal body function and require medical intervention.
No
The device is a knee replacement system (prosthesis), designed to replace a damaged knee joint, not to diagnose a condition.
No
The device description explicitly states that the RT-PLUS™ Knee System consists of femoral, tibial, and patellar components, which are physical implants. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the RT-PLUS™ Knee System is a "replacement of the knee joint". This describes a surgical implant used in vivo (within the body) to replace a damaged anatomical structure.
- Device Description: The description details the components of a prosthetic knee joint (femoral, tibial, and patellar components) and how they function as a "rotating hinged prosthesis". This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body.
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 nonfunctional: MCL, LCL, PCL, ACL and the iliotibial band.
Product codes
KRO
Device Description
The snapping mechanism of the PE tibial inserts for the RT-PLUS™ Device Knee System (S/E May 11, 2001 - K003504) has been modified by adding a clamp to secure the PE insert to the tibial component. All PE tibial inserts of the predicate device have been modified, and they are available in sizes 2, 4, 6, 8 and 10, and each size in 8 mm, 11 mm, 14 mm and 17 mm height.
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
Biomechanical tests have been performed. The test results of the modified components were superior to the predicate device and are sufficient for in vivo loading.
Key Metrics
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
KO21714
510(k) Summary of Safety and Effectiveness
[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
| Contact: | PLUS ORTHOPEDICS |
|---|---|
| 6055 Lusk Blvd. | |
| San Diego, CA 92121 | |
| Tel: 858-550-3800 x 2506 | |
| Attn: Mr. Hartmut Loch, RAC | |
| Director, Regulatory Affairs |
- Trade name: RT-PLUS™ Knee System
Hinged Knee Prosthesis Common name:
Classification Prosthesis Knee, Femorotibial, Constrained, Cemented, Metal/Polymer § 888.3510 - Class II - Product Code: KRO - 87 Orthopedic Device Panel name:
Predicate Device: RT-PLUS™ Knee System, K003504 - S/E 5/11/01
The snapping mechanism of the PE tibial inserts for the RT-PLUS™ Device Knee System (S/E May 11, 2001 - K003504) has been modified by Modification Description: adding a clamp to secure the PE insert to the tibial component. All PE tibial inserts of the predicate device have been modified, and they are available in sizes 2, 4, 6, 8 and 10, and each size in 8 mm, 11 mm, 14 mm and 17 mm height.
- Indications: 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 nonfunctional: MCL, LCL, PCL, ACL and the iliotibial band.
- 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 Biomechanical tests have been performed. The test results of the data: modified components were superior to the predicate device and are sufficient for in vivo loading.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a row, with a flowing design element below them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2002
Mr. Hartmut Loch, RAC Director, Regulatory Affairs PLUS Orthopedics 6055 Lusk Boulevard San Diego, CA 92121-2700
Re: K021714
Trade/Device Name: RT-PLUSTM Knee System Regulation Number: 21 CFR §888.3510 Regulation Name: Knee joint femortibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: May 21, 2002 Received: May 23, 2002
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 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.
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 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.
2
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 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 (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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, please contact the Office of Compliance at (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 of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Sincerely yours,
Mark A. Milken
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
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SPECIAL 510(K) DEVICE MODIFICATION RT-PLUS™ PE Insert Clamp May 21, 2002
Page 1 of of 1
K021714 510(k) Number:
RT-PLUS™ PE Insert Clamp Device Name(s):
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)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional format 1-2-96)
for Mark A. Milliken
ivision of General, Restorative nd Neurological Devices
510(k) Number K021714