(93 days)
No
The document describes a mechanical knee implant and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, a knee replacement component, is used to restore mobility and reduce pain in patients suffering from various knee conditions, which are therapeutic goals.
No
The device description clearly states it is a "tibial insert" and "implants", which are components of a knee replacement system used for treatment, not diagnosis. The "Intended Use" section also describes conditions for which "Joint replacement is indicated", further solidifying its role as a therapeutic device.
No
The device description clearly states it is a physical implant (tibial insert) made from UHMWPE and intended to mate with a metal tibial base implant. It also mentions instruments. This is a hardware medical device.
No, 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 provide information about a person's health.
- Device Description: The provided text describes a knee implant, specifically a tibial insert made of UHMWPE, designed to be surgically implanted into a patient's knee joint during a total knee arthroplasty (TKA) procedure.
- Intended Use: The intended use is to replace damaged joint surfaces in patients suffering from various knee conditions, restoring mobility and reducing pain. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant, which falls under a different category of medical devices than IVDs.
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 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 CR Knee™ Tibial Insert is a line extension to the EMPOWR platform, to include Cruciate Retaining Knee implants and instruments, which provides surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences. The Empowr CR Knee™ Tibial Insert utilizes a PCL (posterior cruciate ligament) retaining TKA (total knee arthroplasty) procedure.
The tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE. The tibial inserts are intended to mate with tibial base implants made from cast CoCr alloy per ASTM F75. The Empowr CR Knee™ Tibial Insert implants provide a kinematically relevant bearing geometry for the knee's primary articulating surfaces, replacing the medial and lateral tibial compartments. The articular geometry features a less conforming asymmetric condylar surfaces to match the highly polished Empowr 3D distal femoral implant's asymmetric condylar surfaces. The distal side of the implant includes a precisely machined coupling designed to interface and lock with the EMPOWR tibial base implant. The tibial insert implant also offers soft tissue relief sections in the anterior region for the patellar tendon and the posterior region for the PCL in PCL retaining procedures.
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: Mechanical testing (Constraint testing, contact area testing, and locking mechanism testing) has demonstrated the device's ability to perform under expected conditions. 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 (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.
K933539, K100900, K963028, K020114
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Encore Medical, L.P. Desiree Wells Regulatory Affairs Specialist 9800 Metric Blvd. Austin, Texas 78758
May 31, 2017
Re: K170573
Trade/Device Name: Empowr CR Knee Tibial Insert 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: February 24, 2017 Received: February 27, 2017
Dear Desiree Wells:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (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 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.
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) K170573
Device Name Empowr CR Knee™ 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 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Date: May 24, 2017
Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Desireé Wells Regulatory Affairs Specialist Phone: (512) 834-6302 Fax: (760) 597-3466 Email: desiree.wells@djoglobal.com
| Product | Common Name | Classification | Product Code |
|---|---|---|---|
| Empowr CR Knee™ Tibial Insert | Cruciate-retaining tibial | ||
| insert | Class II | JWH |
| 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 CFR 888.3560 |
Description:
The Empowr CR Knee™ Tibial Insert is a line extension to the EMPOWR platform, to include Cruciate Retaining Knee implants and instruments, which provides surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences. The Empowr CR Knee™ Tibial Insert utilizes a PCL (posterior cruciate ligament) retaining TKA (total knee arthroplasty) procedure.
The tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE. The tibial inserts are intended to mate with tibial base implants made from cast CoCr alloy per ASTM F75. The Empowr CR Knee™ Tibial Insert implants provide a kinematically relevant bearing geometry for the knee's primary articulating surfaces, replacing the medial and lateral tibial compartments. The articular geometry features a less conforming asymmetric condylar surfaces to match the highly polished Empowr 3D distal femoral implant's asymmetric condylar surfaces. The distal side of the implant includes a precisely machined coupling designed to interface and lock with the EMPOWR tibial base implant. The tibial insert implant also offers soft tissue relief sections in the anterior region for the patellar tendon and the posterior region for the PCL in PCL retaining procedures.
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.
4
Predicate Devices:
Primary Predicate Device: Empowr Knee System - K143242
Reference Devices:
- Foundation PS Knee - K933539
- Movation Knee System - K100900
- Foundation Ultra Congruent - K963028
- 3DKnee System K020114 ●
Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in implant material, manufacturing process, snap lock interface, design of the tibial insert, indications, intended use, packaging and sterilization.
Key Differences in Subject Device to Predicate: Offers an additional intermediate thickness, a higher anterior lip geometry and lower posterior lip geometry, asymmetric condyle geometries and a different coronal conformity ratio.
Non-Clinical Testing: Mechanical testing (Constraint testing, contact area testing, and locking mechanism testing) has demonstrated the device's ability to perform under expected conditions. 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.