(55 days)
No
The summary describes a mechanical implant (femoral component for knee replacement) and its material properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is clearly indicated for treating various medical conditions (e.g., arthritis, avascular necrosis, fractures) and is described as a means of "restoring mobility and reducing pain," which aligns with the definition of a therapeutic device.
No
This device is an orthopedic implant (femoral component for total knee arthroplasty) used for treatment/replacement, not for diagnosing a condition.
No
The device description clearly states it is a physical femoral component for total knee arthroplasty, including a porous coating and hydroxyapatite surface. It is a hardware device.
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 total knee arthroplasty to treat various conditions affecting the femoral condyle. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a porous femoral component with a hydroxyapatite coating, designed for surgical implantation. This is consistent with a medical device used in surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on mechanical testing, abrasion, wear, and endotoxin assessment, which are relevant for a surgical implant, not an IVD.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) as a replacement joint component.
N/A
Intended Use / Indications for Use
The DJO EMPOWR POROUS FEMUR WITH HAnano Surface™ is indicated for use in total knee arthroplasty patients, receiving total joint replacement because of disability or suffering 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. The device is intended for uncemented 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
MBH
Device Description
The EMPOWR Porous Femur with HA""™ Surface is a line extension to the EMPOWR Knee Platform and EMPOWR Porous Knee Platform (cleared via K143242 and K171991), to include a hydroxyapatite-coated porous femoral component in the system.
The EMPOWR Porous Femur with HA"" Surface™ has an adjunct hydroxyapatite (HA) coating on the 3D Matrix® porous coating inside the cement pocket. Since the device is porous coated, it is indicated for cementless use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral condyle
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: Abrasion testing, pin-on-disk wear testing and cleanability testing was performed on the subject device, demonstrating its ability to perform under expected conditions. As the geometry of the subject device is identical to previously cleared EMPOWR Porous Femur, prior mechanical testing (femur fatigue testing, contact area testing) has demonstrated the device's ability to perform under anticipated clinical conditions. All testing has determined that the device is substantially equivalent to the predicate device.
Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing. Assessments were performed per USP and ANSI/AAMI ST72, with an acceptance criterion of 20 EU/device.
Clinical Testing: Clinical testing was not required
Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K101225, K170392, K190025, K201614
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
March 30, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the U.S. 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Encore Medical, L.P. Christine Chesnutt Regulatory Affairs Specialist 9800 Metric Blvd. Austin, Texas 78758
Re: K210308
Trade/Device Name: EMPOWR Porous Femur with HAMano Surface™ 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: February 1, 2021 Received: February 3, 2021
Dear Christine Chesnutt:
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. 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) K210308
Device Name EMPOWR POROUS FEMUR with HAnano Surface™
Indications for Use (Describe)
The DJO EMPOWR POROUS FEMUR WITH HAnano Surface™ is indicated for use in total knee arthroplasty patients, receiving total joint replacement because of disability or suffering 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. The device is intended for uncemented 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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3
510(k) Summary
Date: March 28, 2021
Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Christine Chesnutt Regulatory Affairs Specialist Phone: (512) 834-6207 Fax: (760) 597-3466 Email: christine.chesnutt@djoglobal.com
Product | Common Name | Classification | Product Code |
---|---|---|---|
EMPOWR POROUS FEMUR | |||
with HAnano Surface™ | Total Knee Implant | Class II | MBH |
Product Code | Regulation and Classification Name |
---|---|
MBH | Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis |
per 21 CFR 888.3565 |
Description:
The EMPOWR Porous Femur with HA"™ Surface is a line extension to the EMPOWR Knee Platform and EMPOWR Porous Knee Platform (cleared via K143242 and K171991), to include a hydroxyapatite-coated porous femoral component in the system.
The EMPOWR Porous Femur with HA"" Surface™ has an adjunct hydroxyapatite (HA) coating on the 3D Matrix® porous coating inside the cement pocket. Since the device is porous coated, it is indicated for cementless use.
Indications for Use:
The DJO EMPOWR POROUS FEMUR WITH HA"™" Surface™ is indicated for use in total knee arthroplasty patients, receiving total joint replacement because of disability or suffering 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. The device is intended for uncemented 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:
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K210308 Page 2 of 2
- Empowr Porous Femur (K171991) ●
Comparable Features to Predicate Device(s):
The EMPOWR Porous Femur with HA™® Surface™ line extension includes a modified version of the EMPOWR Porous Femur. The substrate material, articulating geometry, articulating surface roughness, porous coating and bone-facing geometry are identical to the EMPOWR Porous Femur.
Key Differences in Subject Device to Predicate:
The only modification made to the EMPOWR Porous Femur with HA"(000 Surface™ is the addition of a hydroxyapatite coating, the HA""" Surface™, to the 3D Matrix® porous coating on the bone-facing side of the femoral component. This HA™" coating has been previously utilized in several dental and spinal applications (K101225, K170392, K190025. K201614). The process used to apply the coating to the femur is analogous to those seen in previously cleared product. As the device is porous coated, it is indicated for cementless use.
Non-Clinical Testing: Abrasion testing, pin-on-disk wear testing and cleanability testing was performed on the subject device, demonstrating its ability to perform under expected conditions. As the geometry of the subject device is identical to previously cleared EMPOWR Porous Femur, prior mechanical testing (femur fatigue testing, contact area testing) has demonstrated the device's ability to perform under anticipated clinical conditions. All testing has determined that the device is substantially equivalent to the predicate device.
Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing. Assessments were performed per USP and ANSI/AAMI ST72, with an acceptance criterion of 20 EU/device.
Clinical Testing: Clinical testing was not required
Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.