(70 days)
Not Found
No
The device description and performance studies focus on mechanical components and their substantial equivalence to predicate devices, with no mention of AI/ML or related concepts.
Yes
The device is a knee replacement system that aims to alleviate disability caused by various knee conditions, including arthritis, avascular necrosis, and fractures, thereby directly treating a medical condition and restoring function.
No
This device is a knee replacement component, specifically an augment and a stem extension, used in surgical procedures. Its purpose is to treat existing conditions or failed surgeries, not to diagnose a condition.
No
The device description clearly states that the submission is for adding physical components (femoral augment and stem extension) made of Ti alloy and CoCrMo alloy to an existing knee replacement system. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes a surgical implant for joint replacement to treat various knee conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a physical implant (femoral augment and stem extension) made of metal alloys, designed to be surgically implanted. This is consistent with a medical device, not an IVD which typically involves testing samples outside the body.
- No mention of in vitro testing: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic procedures performed outside the body.
- Performance Studies: The performance studies described are non-clinical testing involving drawing review and bone model evaluation, which are typical for surgical implants, not IVDs.
Therefore, this device is a surgical implant intended for therapeutic use in joint replacement, not an In Vitro Diagnostic device.
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 system is to be used for cemented applications.
Exprt Revision Knee Femoral Augments are also to be attached to the femoral component with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
This Special 510(k) is to add additional components to the currently cleared Exprt Revision Knee. These components are as described as follows:
A 5mm thick, machined, Ti alloy, distal femoral augment which will be available in 4 sizes. The augment covers either the posterior femoral resection in a horizontal orientation or the distal femoral resection in a vertical orientation and fits within the cement pocket of the femoral component.
A shorter cemented stem extension for use with both the tibial base plate and the femoral component. The stem, made from CoCrMo alloy, is fluted along its length for rotational constraint when cemented. The stem is available in a 40mm long, straight configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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: Analyses were performed which included drawing review with tolerance stack ups and anatomic bone model evaluation. All evaluations have determined that the devices are substantially equivalent to the applicable predicate devices.
Clinical Testing: Clinical testing was not required.
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2016
Encore Medical, L.P. % Teffany Hutto Manager. Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K161945
Trade/Device Name: EXPRT Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension(40mm) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 22, 2016 Received: August 24, 2016
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
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,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K161945 |
| Device Name | EXPRT Revision Knee Femoral Augment (5mm) EXPRT Revision Knee Stem Extension (40mm) |
| 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 system is to be used for cemented applications. | |
| Exprt Revision Knee Femoral Augments are also to be attached to the femoral component with bone cement. | |
| 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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FORM FDA 3881 (8/14) Page 1 of 1
3
510(k) Summary
Date: September 23, 2016
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
| Product | Classification | Product Code | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| Exprt Revision Knee Femoral Augment (5mm) | ||||
| Exprt Revision Knee Stem Extension (40mm) | Class II | JWH | JWH | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented |
| prosthesis per 21 CFR 888.3560 |
Description:
This Special 510(k) is to add additional components to the currently cleared Exprt Revision Knee. These components are as described as follows:
A 5mm thick, machined, Ti alloy, distal femoral augment which will be available in 4 sizes. The augment covers either the posterior femoral resection in a horizontal orientation or the distal femoral resection in a vertical orientation and fits within the cement pocket of the femoral component.
A shorter cemented stem extension for use with both the tibial base plate and the femoral component. The stem, made from CoCrMo alloy, is fluted along its length for rotational constraint when cemented. The stem is available in a 40mm long, straight configuration.
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 system is to be used for cemented applications.
Exprt Revision Knee Femoral Augments are also to be attached to the femoral component with bone cement.
Predicate Devices: DJO Surgical Foundation Knee Augment Blocks - K941306 DJO Surgical Exprt Revision Knee - K140830
4
Comparable Features to Predicate Device(s):
These components are comparable to the predicate devices in indications, material, design features, surgical implantation technique, intended use, packaging, and sterilization.
Key Differences in Subject Device to Predicate: Femoral stem augments: Different method of fixation to predicate. Stem extension: Shorter length than predicate.
Endotoxin Assessment: Bacterial endotoxin testing was conducted and was found to meet the expected endotoxin limits.
Non-Clinical Testing: Analyses were performed which included drawing review with tolerance stack ups and anatomic bone model evaluation. All evaluations have determined that the devices are substantially equivalent to the applicable predicate devices.
Clinical Testing: Clinical testing was not required.