(93 days)
No
The summary describes a knee replacement system with porous coating for biological fixation. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, a knee replacement system, is indicated for patients suffering from various conditions like arthritis, avascular necrosis, and fractures, aiming to alleviate disability and restore function, which are characteristic of a therapeutic device.
No
This device is a knee replacement system, which is a therapeutic device used to treat joint conditions. It does not diagnose any conditions.
No
The device description explicitly details physical implants (femoral and tibial baseplate implants) and instruments, which are hardware components. The summary also mentions mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for joint replacement to treat various conditions affecting the knee joint. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a knee implant (femoral and tibial components) with porous coating for biological fixation. This is a physical device implanted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro analysis.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
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 3DKNEE™ Porous Tibia which are intended for cementless applications.
Product codes
MBH
Device Description
The EMPOWR POROUS KNEE System is a line extension to the EMPOWR Knee platform (cleared via K143242), to include porous coated femoral and tibial baseplate implants and instruments, which provide surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences.
The EMPOWR 3DKNEE Porous Femur has porous coating applied inside of the cement pocket. The added porous coating allows for long term biological fixation of the device. Therefore, this device is indicated for cementless use.
The EMPOWR Porous Tibia also have a porous coating applied to the backside of the baseplate to allow for long term biological fixation of the device. The distal geometry includes 4 peripheral pegs for initial fixation along with a fully webbed keel to provide rotational stability and initial fixation.
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 (femur fatigue testing, baseplate fatigue 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
October 4, 2017
Image /page/0/Picture/1 description: The image shows 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 words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Encore Medical, L.P. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, Texas 78758
Re: K171991
Trade/Device Name: EMPOWR Porous Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH Dated: June 30, 2017 Received: July 3, 2017
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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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 (DICE) 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 (DICE) 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, Katherine D. Kavlock -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171991
Device Name EMPOWR Porous 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 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ Porous Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR 3DKNEE™ Porous Tibia which are intended for cementless applications.
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) |
| 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: September 29, 2017
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 Porous Knee System | Total Knee Implant | Class II | MBH |
| Product Code | Regulation and Classification Name |
|---|---|
| MBH | 21 CFR 888.3565, Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated |
| Uncemented Prosthesis |
Description:
The EMPOWR POROUS KNEE System is a line extension to the EMPOWR Knee platform (cleared via K143242), to include porous coated femoral and tibial baseplate implants and instruments, which provide surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences.
The EMPOWR 3DKNEE Porous Femur has porous coating applied inside of the cement pocket. The added porous coating allows for long term biological fixation of the device. Therefore, this device is indicated for cementless use.
The EMPOWR Porous Tibia also have a porous coating applied to the backside of the baseplate to allow for long term biological fixation of the device. The distal geometry includes 4 peripheral pegs for initial fixation along with a fully webbed keel to provide rotational stability and initial fixation.
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 3DKNEETM Porous Tibia which are intended for cementless applications.
4
Predicate Devices:
- Empowr Knee System (K143242) .
- 3DKnee Porous Femur (K032905) ●
- . FMPTM Porous Coated Acetabular Shells (K072888)
Comparable Features to Predicate Device(s):
The EMPOWR POROUS KNEE line extension includes a modified version of the EMPOWR 3DKNEE™ Non-porous Femoral Implants. The material, articulating geometry, and articulating surface roughness are identical to the EMPOWR 3DKNEE™ Non-porous Femoral Implants.
The EMPOWR POROUS KNEE line extension also includes a modified version of the EMPOWR non-porous Tibial Baseplate Implants. The sizing architecture and proximal geometry remains identical to EMPOWR Non-porous Tibial Baseplate Implants.
Key Differences in Subject Device to Predicate:
The only modification made to the EMPOWR POROUS KNEE implants compared to the EMPOWR 3DKNEE non-porous Femoral Implants is the addition of porous coating inside of the cement pocket. The porous coating material and process is identical to the porous coating applied to an existing DJO femoral component, 3D Knee Porous Femur (K032905). The added porous coating allows for long term biological fixation of the device. Therefore, this device is indicated for cementless use.
The distal side of the EMPOWR Porous Tibia was modified to accommodate a cementless indication. The distal geometry includes 4 peripheral pegs for initial fixation along with a fully webbed keel to provide rotational stability and initial fixation. The backside of the baseplate is also coated with porous coating to allow for long term biological fixation of the device. This porous coating is identical to coating applied to existing FMP™ Porous Coated Acetabular Shells (K072888).
Non-Clinical Testing: Mechanical testing (femur fatigue testing, baseplate fatigue 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.