(101 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The testing described is traditional mechanical and CAD analysis.
Yes
The device is a knee replacement system intended to restore mobility and reduce pain in patients suffering from various knee pathologies, which aligns with the definition of a therapeutic device.
No
Explanation: The provided text describes a total knee replacement system, which is a prosthetic device used for treatment, not for diagnosing medical conditions. Its intended use is to restore mobility and reduce pain in patients with various knee conditions, not to identify or characterize diseases.
No
The device description explicitly states it is a "total knee system that includes non-porous distal femoral implants... and tibial insert implants," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the EMPOWR PS Knee System is a total knee system consisting of implants (femoral and tibial) made from metal and plastic. These are surgically implanted devices, not tests performed on bodily samples.
- Intended Use: The intended use describes the surgical replacement of a joint due to various conditions affecting the knee. This is a surgical procedure, not a diagnostic test.
The information provided describes a medical device intended for surgical implantation, not an in vitro diagnostic test.
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 3DKNEET™ Porous Coated Femur which is 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 (comma separated list FDA assigned to the subject device)
JWH, OIY
Device Description
The EMPOWR PS Knee System is a line extension to the current EMPOWR system (previously cleared as Rebel 3DKNEE System). It is a total knee system that includes non-porous distal femoral implants made from cast CoCr alloy per ASTM F75 and tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE.
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 assessments for PS femur condyle closing loads, PS femur flange closing loads, and PS femur wedge loading. CAD analysis was completed for range of motion, and testing was completed for post fatigue, contact area, constraint, and lateral subluxation. 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): 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.
EMPOWR Knee System - K143242, 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.
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Image /page/0/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 an abstract symbol resembling an eagle or a bird in flight, formed by three stylized human profiles facing to the right. The profiles are layered, creating a sense of depth and movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
Encore Medical, L.P. Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K160342 Trade/Device Name: EMPOWR PS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: May 2, 2016 Received: May 3, 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 (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/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/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
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| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K160342 |
|---|---|
| Device Name | EMPOWR PS Knee 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. All devices are intended for cemented applications except for the 3DKNEET\u2122 Porous Coated Femur which is 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
Page 1 of 1
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510(k) Summary
Date: May 6, 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@djosurgical.com
| Product | Classification | Product Codes | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| EMPOWR PS Knee 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 EMPOWR PS Knee System is a line extension to the current EMPOWR system (previously cleared as Rebel 3DKNEE System). It is a total knee system that includes non-porous distal femoral implants made from cast CoCr alloy per ASTM F75 and tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE.
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 which is 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.
| Predicate Devices: | EMPOWR Knee System - K143242 |
|---|---|
| Foundation PS Knee System - K933539 | |
| Movation Knee System - K100900 & K121727 |
Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in indications, material, dimensions, surgical implantation technique, and intended use. This device has the same implant packaging and sterilization as the EMPOWR Knee are no different technological characteristics from the predicate device.
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K160342 Page 2 of 2 Key Differences in Subject Device to Predicate: Anterior Cam Position within Intercondylar Housing, Values of Coronal Condylar Radii and Bearing Spacing, Femoral Component PS Housing Profile, Posterior Cam Engagement with Tibial Insert, Post Jump Height, Shape of Tibial Insert Post Section, Tibial Insert Post Coronal Profile, Tibial Insert Articular Geometry Conformity Ratio, and Values of Tibial Post Width.
Non-Clinical Testing: FEA assessments for PS femur condyle closing loads, PS femur flange closing loads, and PS femur wedge loading. CAD analysis was completed for range of motion, and testing was completed for post fatigue, contact area, constraint, and lateral subluxation. All testing has determined that the device is substantially equivalent to the predicate devices.
Clinical Testing: None provided.