(90 days)
No
The summary describes a mechanical joint replacement device and its testing, with no mention of AI or ML.
Yes
The device is a knee replacement, which is intended to restore mobility and reduce pain, thus serving a therapeutic purpose.
No
Explanation: The document describes a joint replacement device (knee implant) and accessories, which are used for treatment (restoring mobility and reducing pain) rather than for diagnosing a condition.
No
The device description clearly states it is a "Tibial Insert and accessory," which are physical components intended for surgical implantation. The performance studies also focus on mechanical testing of these physical components.
Based on the provided text, 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, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states this device is a "Joint replacement" and specifically a "Tibial Insert" for the knee. This is an implantable medical device used within the body to replace a damaged joint.
- Intended Use: The intended use describes treating conditions like arthritis and fractures by replacing the knee joint. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, not a device used for testing biological samples.
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. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR Porous™ Knee Femur and EMPOWR Porous™ Knee Tibia which are intended for cementless applications.
While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Product codes
JWH, OIY
Device Description
The EMPOWR Varus / Valgus Constrained (VVC) Tibial Insert and accessory is a line extension to the EMPOWR Knee platform (cleared via K143242), to include a more constrained tibial insert component that provides additional internal / external and varus / valgus rotational stability, which provide surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences.
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
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. This testing includes:
- Femoral Tibial Contact Area ●
- Femoral – Tibial Intrinsic Stability
- VVC Post Fatigue
- Locking mechanism Static Stability and Fatige ●
- Reinforcement Pin Taper Characterization
- Varus / Valgus Constraint Characterization ●
All testing has determined that the device is substantially equivalent to the predicate devices.
Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.
Clinical Testing: Clinical testing was not required
Key Metrics
Not Found
Predicate Device(s)
EMPOWR PS Knee System (K160342), Exprt Knee System (K140830), Foundation Constrained Posterior Stabilized Tibial Insert (K933539)
Reference Device(s)
Encore Medical Acetabular System (K072154), Highly Cross-Linked Vitamin E UHMWPE Tibial Insert (K091956)
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Encore Medical, L.P. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, Texas 78758
Re: K180930
Trade/Device Name: EMPOWR VVC Tibial Insert 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 9, 2018 Received: April 10, 2018
Dear Teffany 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 of medical device-related adverse events) (21 CFR 803); good
July 9, 2018
1
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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
510(k) Number (if known) K180930
Device Name EMPOWR VVC Tibial Insert
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. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR Porous™ Knee Femur and EMPOWR Porous™ Knee Tibia which are intended for cementless applications.
While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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: July 9, 2018
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: (760) 597-3466 Email: teffany.hutto@djoglobal.com
| Product | Common Name | Classification | Product Code |
|---|---|---|---|
| EMPOWR VVC Tibial Insert | Total Knee Implant | Class II | JWH, OIY |
| 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 EMPOWR Varus / Valgus Constrained (VVC) Tibial Insert and accessory is a line extension to the EMPOWR Knee platform (cleared via K143242), to include a more constrained tibial insert component that provides additional internal / external and varus / valgus rotational stability, which provide surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences.
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. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur. EMPOWR Porous™ Knee Femur and EMPOWR Porous™ Knee Tibia which are intended for cementless applications.
While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
4
Predicate Devices:
- EMPOWR PS Knee System (K160342)
- Exprt Knee System (K140830)
- Foundation Constrained Posterior Stabilized Tibial Insert (K933539) ●
Reference Devices:
- Encore Medical Acetabular System (K072154)
- Highly Cross-Linked Vitamin E UHMWPE Tibial Insert (K091956) ●
Comparable Features to Predicate Device(s):
The EMPOWR VVC Tibial Insert Implant is a line extension also includes a modified version of the EMPOWR PS Tibial Insert Implants (cleared via K160342). The sizing architecture, material (highly crosslinked UHMWPe with vitamin E per ASTM F648), minimum thickness offering (10mm), and distal locking mechanism geometry with the mating tibial baseplate remains identical to EMPOWR PS Tibial Insert Implants.
Key Differences in Subject Device to Predicate:
A primary difference between the EMPOWR VVC Tibial Insert compared to the EMPOWR PS Tibial Insert Implants is the proximal side of the tibial insert and post geometry was modified to configure an additional amount of internal / external and varus / valgus constraint when compared to the EMPOWR PS Tibial Insert Implants.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. This testing includes:
- Femoral Tibial Contact Area ●
- Femoral – Tibial Intrinsic Stability
- VVC Post Fatigue
- Locking mechanism Static Stability and Fatige ●
- Reinforcement Pin Taper Characterization
- Varus / Valgus Constraint Characterization ●
All testing has determined that the device is substantially equivalent to the predicate devices.
Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.
Clinical Testing: Clinical testing was not required
Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.