(61 days)
No
The summary describes a mechanical knee implant system and its components, with no mention of AI or ML technology in its design, function, or performance studies.
Yes
The device is indicated for alleviating painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis, which directly addresses a medical condition to improve health.
No
Explanation: The EMPOWR Partial Knee System is an implantable medical device used to replace parts of the knee joint. Its intended use is for repairing painful and/or disabling knee joints due to various conditions, not for diagnosing them.
No
The device description clearly states it includes physical components (cobalt chrome femoral component, titanium tibial baseplate, and Vitamin E Polyethylene insert), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The EMPOWR Partial Knee System is a physical implant designed to replace parts of the knee joint. It is surgically implanted into the body.
- Intended Use: The intended use describes treating painful and/or disabling knee joints due to conditions like osteoarthritis or fractures. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant used for treatment, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The EMPOWR Partial Knee System is indicated for patients with:
- · Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
- · Previous tibial condyle or plateau fractures with loss of anatomy or function.
- Varus or valgus deformities.
- · Revision procedures where other treatments or devices have failed.
- · These devices are indicated for cemented use only.
Product codes
HSX
Device Description
The EMPOWR Partial Knee is a unicompartmental knee system that is unconstrained in the anteroposterior and mediolateral directions, allowing unconstrained internal/external rotation between the femoral and tibial components. This system includes a cobalt chrome femoral component, titanium tibial baseplate, and Vitamin E Polyethylene insert.
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: Mechanical testing has demonstrated the device's ability to perform under expected conditions. This testing includes:
- FEA for Femur Component Strength
- Tibial Baseplate Component Strength Testing ●
- Range of Motion Assessment ●
- Tibial-femoral Contact Area Testing ●
- Static Locking Mechanism Disassembly
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
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July 16, 2019
Encore Medical, L.P. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, Texas 78758
Re: K191325
Trade/Device Name: EMPOWR Partial Knee Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: May 15, 2019 Received: May 16, 2019
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
For CAPT Raquel Peat, PhD, MPH, USPHS Director 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) K191325
Device Name EMPOWR Partial Knee
Indications for Use (Describe)
The EMPOWR Partial Knee System is indicated for patients with:
- · Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
- · Previous tibial condyle or plateau fractures with loss of anatomy or function.
- Varus or valgus deformities.
- · Revision procedures where other treatments or devices have failed.
- · These devices are indicated for cemented use only.
Type of Use (Select one or both, as applicable)
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: July 16, 2019
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 Partial Knee | Partial Knee Implant | Class II | HSX |
| Product Code | Regulation and Classification Name |
|---|---|
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer per 21 CFR |
| 888.3520 |
Description:
The EMPOWR Partial Knee is a unicompartmental knee system that is unconstrained in the anteroposterior and mediolateral directions, allowing unconstrained internal/external rotation between the femoral and tibial components. This system includes a cobalt chrome femoral component, titanium tibial baseplate, and Vitamin E Polyethylene insert.
Indications for Use:
The EMPOWR Partial Knee System is indicated for patients with:
- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. o
- Previous tibial condyle or plateau fractures with loss of anatomy or function. ●
- Varus or valgus deformities. ●
- o Revision procedures where other treatments or devices have failed.
These devices are indicated for cemented use only.
Predicate Devices:
| Device | Manufacturer | 510(k) Number | Predicate Type |
|---|---|---|---|
| Zimmer® Unicompartmental Knee | Zimmer Biomet | K033363 | Primary |
| EPIK Knee System | Encore Medical, L.P. | K020741 | Reference Device |
4
Comparable Features to Predicate Device(s):
- Indications for Use ●
- Material of Femoral and Tibial Baseplate components. (Femoral component Cobalt o Chrome, Tibial Baseplate - Titanium)
- Tibial baseplate component sizing and dimensions
- Insert thicknesses ●
- Femoral Component Size offerings
- 2-peg femoral design
- Keel and 2-peg tibial baseplate design ●
- Unconstrained tibial insert articulation
Key Differences in Subject Device to Predicate:
- Femoral component profile and articular surface geometry ●
- o Tibial baseplate peg and keel geometry
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. This testing includes:
- FEA for Femur Component Strength
- Tibial Baseplate Component Strength Testing ●
- Range of Motion Assessment ●
- Tibial-femoral Contact Area Testing ●
- Static Locking Mechanism Disassembly
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.