(184 days)
Not Found
No
The summary describes a total knee replacement system and its components, with no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes.
The device, a total knee system, is designed for joint replacement to treat disabilities and conditions like arthritis, avascular necrosis, and fractures, which directly alleviate or prevent conditions.
No
The device is a total knee system, which are implants used for joint replacement, not for diagnosis.
No
The device description explicitly states it is a "total knee system that includes non-porous distal femoral implants... tibial insert implants... and tibial base implants," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for replacing a joint due to various conditions affecting the knee. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a total knee system made of materials like CoCr alloy and UHMWPE, designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an in vivo surgical implant.
N/A
Intended Use / Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
degenerative, post-traumatic or rheumatoid arthritis;
avascular necrosis of the femoral condyle;
post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy:
moderate valgus, varus or flexion deformities;
treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used for cemented applications.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OIY
Device Description
The REBEL™ 3DKNEE SYSTEM is a line extension to the current 3DKNEE system. It is a total knee system that includes non-porous distal femoral implants made from cast CoCr alloy per ASTM F75, tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE, and tibial base implants made from cast CoCr alloy per ASTM F75.
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)
Non-Clinical Testing: FEA to assess load conditions, patella subluxation, contact area/contact stress, tibial-femoral contact area, and tibial-femoral subluxation testing has determined that the device is substantially equivalent to the predicate devices.
Clinical Testing: None provided.
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.
3DKNEE System - K020114 & K091956, Foundation Knee System - K923277, Foundation PS Knee System - K933539, Movation Knee System - K100900 & K121727
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
May 15, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Encore Medical, L.P. Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K143242 Trade/Device Name: Rebel 3DKNEE System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: April 10, 2015 Received: April 13, 2015
Dear Ms. Hutto:
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
1
Page 2 - Ms. Teffany Hutto
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143242
Device Name Rebel 3DKNEE System
Indications for Use (Describe)
Joint replacement is indicated for patients suffering from disability due to:
degenerative, post-traumatic or rheumatoid arthritis;
avascular necrosis of the femoral condyle;
post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy:
moderate valgus, varus or flexion deformities;
treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used for cemented applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒Prescription Use (Part 21 CFR 801 Subpart D) | ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Date: May 7, 2015
Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djosurgical.com
| Product | Classification | Product Codes | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| Rebel TM 3DKNEE System | Class II | JWH, OIY | JWH | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented |
| prosthesis per 888.3560 | ||||
| OIY | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented | |||
| prosthesis per 888.3560 |
Description:
The REBEL™ 3DKNEE SYSTEM is a line extension to the current 3DKNEE system. It is a total knee system that includes non-porous distal femoral implants made from cast CoCr alloy per ASTM F75, tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE, and tibial base implants made from cast CoCr alloy per ASTM F75.
Indications for Use:
Joint replacement is indicated for patients suffering from disability due to:
- degenerative, post-traumatic or rheumatoid arthritis; ●
- . avascular necrosis of the femoral condyle;
- post-traumatic loss of joint configuration, particularly when there is patellofemoral ● erosion, dysfunction or prior patellectomy;
- moderate valgus, varus or flexion deformities;
- treatment of fractures that are unmanageable using other techniques. ●
This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used for cemented applications.
| Predicate Devices: | 3DKNEE System - K020114 & K091956 |
|---|---|
| Foundation Knee System - K923277 | |
| Foundation PS Knee System - K933539 | |
| Movation Knee System - K100900 & K121727 |
Comparable Features to Predicate Device is comparable to the current 3DKNEE System in indications, material, dimensions, surgical implantation technique, and intended use. This device has the same implant packaging and sterilization as the 3DKNEE System.
Non-Clinical Testing: FEA to assess load conditions, patella subluxation, contact area/contact stress, tibial-femoral contact area, and tibial-femoral subluxation testing has determined that the device is substantially equivalent to the predicate devices.
Clinical Testing: None provided.