(100 days)
Not Found
No
The device description focuses on the mechanical design and components of a knee replacement system, with no mention of AI or ML capabilities. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is a joint replacement system (knee) intended to treat conditions like arthritis, avascular necrosis, and fractures, which directly alleviate a disease or injury.
No
This device is a joint replacement system (revision knee) used for surgical implantation, not for diagnosing medical conditions. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is comprised of physical components (Femur, Tibial Insert, and Tibial Baseplate) and is intended for cemented applications, indicating a hardware implant.
Based on the provided information, 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 description clearly states that the device is a "Joint replacement" system comprised of "Femur, Tibial Insert, and Tibial Baseplate." These are physical implants designed to replace parts of the knee joint.
- Intended Use: The intended use describes the conditions for which the joint replacement is indicated, all of which relate to physical problems with the knee joint itself.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples, perform tests, or provide diagnostic information about a patient's health status based on biological samples.
This device is a surgical implant used for the treatment of knee joint issues, not for in vitro diagnostic testing.
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 patellectorny;
- moderate valgus, varus or flexion deformities:
- treatment of fractures that are unmanageable using other techniques. .
The patient's joint must be anatomically and structurally suited to receive the selected implant(s). This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications
Product codes
JWH, OIY
Device Description
The Exprt Revision Knee (ERK) is a tri-compartmental posterior stabilized knee for cemented applications. The system is comprised of three primary components: Femur, Tibial Insert, and Tibial Baseplate. The system is intended to treat patients who are candidates for revision total knee arthroplasty or difficult primary arthroplasty where bone loss may be substantial and the collateral ligaments may be compromised. The design of the knee system is a total condylar design, increasing sagittal conformity and stability. The post and cam of the posterior stabilized design are crucial to inducing femoral rollback and providing resistance to tibial subluxation, substituting the function of the absent PCL. The tibial post, in combination with the femoral cam, provides for greater patient flexion by forcing the femur posteriorly on the tibia.
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: Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing included static contact area/contact stress testing, static testing in anterior-posterior draw, static testing in rotary laxity, and patella subluxation evaluation. All 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)
K933539, K100900, K121727, K130365
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 1 1 2014
510(k) Summarv
Date: April 4, 2014
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@djoglobal.com
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| Product Code | Regulation and Classification Name |
|---|---|
| JWH | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis |
| per 21 CFR 888.3560 | |
| OIY | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis |
| per 21 CFR 888.3560 |
Description:
The Exprt Revision Knee (ERK) is a tri-compartmental posterior stabilized knee for cemented applications. The system is comprised of three primary components: Femur, Tibial Insert, and Tibial Baseplate. The system is intended to treat patients who are candidates for revision total knee arthroplasty or difficult primary arthroplasty where bone loss may be substantial and the collateral ligaments may be compromised. The design of the knee system is a total condylar design, increasing sagittal conformity and stability. The post and cam of the posterior stabilized design are crucial to inducing femoral rollback and providing resistance to tibial subluxation, substituting the function of the absent PCL. The tibial post, in combination with the femoral cam, provides for greater patient flexion by forcing the femur posteriorly on the tibia.
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 patellectorny;
- moderate valgus, varus or flexion deformities:
- treatment of fractures that are unmanageable using other techniques. .
The patient's joint must be anatomically and structurally suited to receive the selected implant(s). This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications
Predicate Devices:
DJO Surgical Foundation PS Knee System - K933539 DJO Surgical Movation Knee System -- K100900, K121727 DJO Surgical e+ FMP Acetabular Liner (Accessory Sterilization) -- K130365
Page 1 of 2
1
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same material, indications, surgical implantation technique, and intended use. The same technological characteristics include: same size offerings, same posterior stabilization, same tibial snap lock feature, and same femoral component box width. Differences to the predicate include tibial baseplate dimensions, femoral component dimensions, tibial insert post height, and length of the stem extensions.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing included static contact area/contact stress testing, static testing in anterior-posterior draw, static testing in rotary laxity, and patella subluxation evaluation. All testing has determined that the device is substantially equivalent to the predicate devices.
Clinical Testing: None provided.
Page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2014
Encore Medical, L.P. Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K140830 Trade/Device Name: Exprt™ Revision Knee Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: June 5, 2014 Received: June 6, 2014
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Teffany Hutto
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/ResourcesforYou/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/ReportalProblem/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,
Lori A. Wiqqins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K140830 510(k) Number (if known):
Device Name: Exprt Revision Knee
Indications for Use:
Exprt™ Revision Knee 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. .
The patient's joint must be anatomically and structurally suited to receive the selected implant(s).
This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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