(116 days)
No
The summary describes a traditional knee replacement implant and associated instruments. There is no mention of AI/ML in the intended use, device description, or performance studies. The performance studies focus on mechanical properties and constraint testing, not algorithmic performance.
Yes
The device is a knee replacement system that aims to restore mobility and reduce pain for patients with various knee conditions, which are therapeutic goals.
No
This device is a total knee prosthesis used for joint replacement, not for diagnosing medical conditions.
No
The device description explicitly states the system consists of "sterile implants" and "non-sterile reusable instruments and trials are included as accessories," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for replacing a joint (knee) to treat conditions like arthritis, avascular necrosis, and deformities. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a total knee prosthesis consisting of sterile implants (femur, stem extender, augments) and non-sterile instruments. These are physical components implanted during surgery.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens for diagnostic purposes.
- Performance Studies: The performance studies listed are related to the mechanical properties and function of the implant itself (range of motion, contact area, constraint, fatigue strength, etc.), not to the analysis of biological samples.
In summary, the device is a surgical implant for joint replacement, which is a therapeutic procedure, 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 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR POROUS 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
Device Description
EMPOWR Revision Knee™ is intended for total knee prosthesis. The system consists of the sterile implants; EMPOWR Revision Femur, EMPOWR Stem Extender, and EMPOWR Femoral Augments (Distal and Posterior)- Universal. Non-sterile reusable instruments and trials are included as accessories.
The femur component can optionally be used with a stem extender and/or augments to suit a variety of surgeon preferences and patient anatomies.
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)
The following testing was performed to FDA recognized standards and internal protocols:
- CAD Based Range of Motion (ROM)
- 0 Femur - PS Insert; Contact Area Assessment - ASTM F2083-12
- Femur – VVC Insert; Contact Area Assessment - ASTM F2083-12
- Femur - Insert; Varus / Valgus Constraint - ASTM F1223-14
- Locking Mechanism Disassembly for Total Condylar Knee - ASTM F2083-12
- o Post Fatigue Strength
- Femur-Stem Extender-Stem Fatigue Testing
- Femur Finite Element Analysis (FEA)
- o Augment Screw Characterization
- o Baseplate / Stem Extension Fatigue Testing
- Patella Subluxation Test - ASTM F1672
- Static Patella Contact Area Stress Testing - ASTM F1672
- Intrinsic Stability (Constraint Testing) - ASTM F1223-14
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DJO EMPOWR PS Knee®, K160342, DJO EMPOWR® Universal Tibial Baseplate, K173723, DJO EXPRT® Femoral Augment, K140830
Reference Device(s)
Several reference devices are used to support minor differences in technological features.
Several additional reference devices are used to support minor technological differences and for comparison testing.
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.
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April 1, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
Encore Medical, L.P. Michael Siano Sr. Program Manager, RA 9800 Metric Blvd. Austin, Texas 78758
Re: K213793
Trade/Device Name: EMPOWR Revision Knee Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: February 28, 2022 Received: March 1, 2022
Dear Michael Siano:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, Ph.D., R.A.C. For Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213793
Device Name EMPOWR Revision Knee™
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 3DKNEE™ POROUS Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR POROUS 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)
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the logo for DJO Surgical. The logo consists of a red circle with a white swoosh inside, followed by the text "DJO" in black, and then the word "SURGICAL" in a smaller, lighter font. The logo is simple and modern, and the colors are eye-catching.
510(k) Summary
I. SUBMITTER
Encore Medical, L.P. (dba DJO Surgical) 9800 Metric Blvd. Austin, TX 78758
Phone: 864-3223801 Fax: (512) 834-6313
Contact Person: Michael A. Siano Date Prepared: December 3, 2021
II. DEVICE
Name of Device: EMPOWR Revision Knee™ Common or Usual Name: Knee prosthesis Classification Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis (21 CFR 888.3560) Regulatory Class: II Product Code: JWH
III. PREDICATE DEVICE
DJO EMPOWR PS Knee®, K160342 DJO EMPOWR® Universal Tibial Baseplate, K173723 DJO EXPRT® Femoral Augment, K140830
Several reference devices are used to support minor differences in technological features.
IV. DEVICE DESCRIPTION
EMPOWR Revision Knee™ is intended for total knee prosthesis. The system consists of the sterile implants; EMPOWR Revision Femur, EMPOWR Stem Extender, and EMPOWR Femoral Augments (Distal and Posterior)- Universal. Non-sterile reusable instruments and trials are included as accessories.
The femur component can optionally be used with a stem extender and/or augments to suit a variety of surgeon preferences and patient anatomies.
V. 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.
4
Image /page/4/Picture/0 description: The image shows the logo for DJO Surgical. The logo consists of a red circle with white curved lines inside, followed by the letters "DJO" in black, bold font. To the right of "DJO" is the word "SURGICAL" in a smaller, lighter font.
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 3DKNEE™ POROUS Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR POROUS 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..
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Substantial equivalence is claimed to three separate predicates for the EMPOWR Revision Femur, EMPOWR Stem Extender, and EMPOWR Femoral Augments (Distal and Posterior)- Universal.
Several additional reference devices are used to support minor technological differences and for comparison testing.
In each case, the intended use is the same between the subject and predicate. Comparative testing demonstrates substantial equivalence between the subject and predicate devices.
Biocompatibility testing
The biocompatibility evaluation for the EMPOWR Revision Knee™ was conducted in accordance with the FDA guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, May 1, 1995, and International Standard ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA.
The EMPOWR Revision Knee™ is intended for permanent implantation, contacting tissue/bone.
Biocompatibility was ensured through the use of qualified materials and contact agents.
Performance Testing
The following testing was performed to FDA recognized standards and internal protocols:
- CAD Based Range of Motion (ROM)
- 0 Femur - PS Insert; Contact Area Assessment - ASTM F2083-12
- Femur – VVC Insert; Contact Area Assessment - ASTM F2083-12
- Femur - Insert; Varus / Valgus Constraint - ASTM F1223-14
- Locking Mechanism Disassembly for Total Condylar Knee - ASTM F2083-12
- o Post Fatigue Strength
- Femur-Stem Extender-Stem Fatigue Testing
- Femur Finite Element Analysis (FEA)
- o Augment Screw Characterization
- o Baseplate / Stem Extension Fatigue Testing
- Patella Subluxation Test - ASTM F1672
- Static Patella Contact Area Stress Testing - ASTM F1672
- Intrinsic Stability (Constraint Testing) - ASTM F1223-14
Animal Studies
No animal data submitted.
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Image /page/5/Picture/0 description: The image shows the DJO Surgical logo. The logo features a red circular graphic on the left, followed by the letters "DJO" in bold, black font. To the right of "DJO" is the word "SURGICAL" in a smaller, lighter font.
Clinical Studies
No clinical data submitted.
VIII. CONCLUSIONS
All testing and evaluations demonstrate that the device is substantially equivalent to the predicate.