(76 days)
Not Found
No
The document describes a mechanical implant (tibial insert) and its physical 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 a joint replacement primarily intended to restore mobility and reduce pain for patients suffering from various joint-debilitating conditions. These are direct therapeutic benefits.
No.
The device is a knee joint replacement component (tibial insert) and its purpose is therapeutic, aiming to restore mobility and reduce pain, rather than diagnose a medical condition.
No
The device description clearly describes a physical implant (tibial insert) made of UHMWPE and a reinforcement pin made of CoCr, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is an "EMPOWR Revision VVC+ (Varus / Valgus Constrained) e+ Tibial Insert Implant." This is a physical implant designed to be surgically placed within the knee joint.
- Intended Use: The intended use describes the conditions for which the joint replacement is indicated, all of which relate to physical issues within the knee joint requiring surgical intervention.
- Lack of Biological Sample Testing: There is no mention of the device being used to test biological samples or provide diagnostic information based on such testing.
The device is a surgical implant used in joint replacement procedures, not a diagnostic tool.
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, 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.
The EMPOWR Revision VVC+, e+ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:
· absence or loss of both cruciate ligaments
- · moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgement of the surgeon
- · bone loss that requires supplemental fixation in the clinical judgement of the surgeon
Product codes (comma separated list FDA assigned to the subject device)
JWH, OIY
Device Description
The EMPOWR Revision VVC+ (Varus / Valgus Constrained) e+ Tibial Insert Implant is a line extension that offers an increased level of femoral / tibial constraint over the EMPOWR VVC Tibial Insert. This tibial insert implant provides additional internal / external and varus / valgus rotational stability.
The sizing architecture for the insert includes 14 sizes (2-11, 4BU, 5BU, 6BD, 7BD) and thicknesses of 10mm, 12mm, 14mm, 16mm, 19mm, 22mm and 25mm with post medial/lateral width of 0.5520 inches for sizes 2-5 and 0.7080 inches for sizes 6 - 11. Along with the post width, the articulating geometry of the proximal side of the tibial insert accommodates an additional amount of internal / external (I/E), varus / valgus (V/V) constraint, and tibial post / femoral cam jump height when interfacing with the EMPOWR Revision Femoral implant. The material (highly crosslinked 75kGy UHMWPE with vitamin E per ASTM F2695/F2565) and distal locking mechanism geometry with the mating tibial baseplate are identical to the predicate.
All tibial insert thickness options are configured to interface with a reinforcement pin accessory made of Wrought CoCr per ASTM F1537. This accessory is configured with a taper interface on the distal end to mate with the EMPOWR UNIVERSAL TIBIAL BASEPLATE, has a diameter and length configured to reinforce the post and thickness for the EMPOWR Revision VVC+ e+ tibial insert, and contains barbs to prevent the pin from backout when fully seated within the post of the EMPOWR Revision VVC+, e+ tibial 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)
Performance Testing:
- CAD Based Range of Motion (ROM)
- Femoral – Tibial Contact Area Assessment - ASTM F2083-21
- Femur - Tibial Intrinsic Stability - ASTM F2083-21, ASTM F1223-20
- Femur - Tibial Varus / Valgus Constraint Testing- ASTM F2083-21, ASTM F1223-20
- MR Conditional Labeling - ASTM F2052 -21, ASTM F2213-17, ASTM F2119-07(2013), ASTM F2182-10e2, ASTM F2503-20
Key results: All testing and evaluations demonstrate that the device is substantially equivalent to the predicate.
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.
Not Found
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
April 6, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Encore Medical, L.P. dba Enovis Trey Thorsen Regulatory Affairs Consultant 9800 Metric Boulevard Austin, Texas 78758
Re: K230169
Trade/Device Name: EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: January 20, 2023 Received: January 20, 2023
Dear Trey Thorsen:
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,
Peter G. Allen -S
Digitally signed by Peter G. Allen -S Date: 2023.04.06 17:15:52 -04'00'
For: [Vacant] 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) K230169
Device Name
EMPOWR RevisionVVC +(VARUS / VALGUS CONSTRAINED), e + 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, EMPOWR 3DKNEE™ POROUS Femur, 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.
The EMPOWR Revision VVC+, e+ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:
· absence or loss of both cruciate ligaments
- · moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgement of the surgeon
- · bone loss that requires supplemental fixation in the clinical judgement of the surgeon
Type of Use (Select one or both, as applicable)
| For Evaluation (Test & STEP 201 Subject B) | |
|---|---|
| For Examination (STEP 201 Subject C) |
× 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/1 description: The image shows the logo for Enovis. The word "enovis" is written in a sans-serif font. The "e", "n", and the first half of the "o" are red, while the second half of the "o", "v", "i", and "s" are black. There is a trademark symbol to the right of the "s".
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510(k) Summary
I. SUBMITTER
Encore Medical, L.P. (dba Enovis) 9800 Metric Blvd. Austin, TX 78758
Contact Person: Trey Thorsen Email: trey.thorsen@enovis.com Phone: 850-450-3932
II. DEVICE
Name of Device: EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert Common or Usual Name: Total Knee Implant Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3560
Regulatory Class: II Primary Product Code: JWH Secondary Product Code: OIY
III. PREDICATE DEVICE
DJO EMPOWR Revision Varus / Valgus Constrained Tibial Insert, K180930
IV. DEVICE DESCRIPTION
EMPOWR Revision VVC+ (Varus / Valgus Constrained) e+ Tibial Insert
The EMPOWR Revision VVC+ (Varus / Valgus Constrained) e+ Tibial Insert Implant is a line extension that offers an increased level of femoral / tibial constraint over the EMPOWR VVC Tibial Insert. This tibial insert implant provides additional internal / external and varus / valgus rotational stability.
The sizing architecture for the insert includes 14 sizes (2-11, 4BU, 5BU, 6BD, 7BD) and thicknesses of 10mm, 12mm, 14mm, 16mm, 19mm, 22mm and 25mm with post medial/lateral width of 0.5520 inches for sizes 2-5 and 0.7080 inches for sizes 6 - 11. Along with the post width, the articulating geometry of the proximal side of the tibial insert accommodates an additional amount of internal / external (I/E), varus / valgus (V/V) constraint, and tibial post / femoral cam jump height when interfacing with the EMPOWR Revision Femoral implant. The material (highly crosslinked 75kGy UHMWPE with vitamin E per ASTM F2695/F2565) and distal locking mechanism geometry with the mating tibial baseplate are identical to the predicate.
All tibial insert thickness options are configured to interface with a reinforcement pin accessory made of Wrought CoCr per ASTM F1537. This accessory is configured with a taper interface on the distal end to mate with the EMPOWR UNIVERSAL TIBIAL BASEPLATE, has a diameter and length configured to reinforce the post and thickness for the EMPOWR Revision VVC+ e+ tibial insert, and contains barbs to
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| Page 2 of 3
prevent the pin from backout when fully seated within the post of the EMPOWR Revision VVC+, e+ tibial insert.
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.
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.
The EMPOWR Revision VVC+, e+ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:
- absence or loss of both cruciate ligaments
- . moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgement of the surgeon
- . bone loss that requires supplemental fixation in the clinical judgement of the surgeon
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The EMPOWR Revision VVC+, e+ Tibial Insert and accessories are a line extension to the predicate EMPOWR Varus / Valgus Constrained Tibial Insert (cleared via K180930).
Comparative testing demonstrates substantial equivalence between the subject and predicate device.
Biocompatibility testing
The biocompatibility evaluation for the EMPOWR Revision VVC+, e+ Tibial Insert 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 VVC+, e+ Tibial Insert is intended for permanent implantation, contacting tissue/bone. Biocompatibility was ensured through the use of qualified materials and contact agents.
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Image /page/5/Picture/1 description: The image shows the logo for "enovis". The first two letters, "en", are in red, while the "o" is a black circle with a gradient effect. The letters "vis" are in black, and there is a small trademark symbol in the lower right corner of the logo.
Performance Testing
The following testing was performed to FDA recognized standards and internal protocols:
- . CAD Based Range of Motion (ROM)
- Femoral – Tibial Contact Area Assessment - ASTM F2083-21
- O Femur - Tibial Intrinsic Stability - ASTM F2083-21, ASTM F1223-20
- . Femur - Tibial Varus / Valgus Constraint Testing- ASTM F2083-21, ASTM F1223-20
- . MR Conditional Labeling - ASTM F2052 -21, ASTM F2213-17, ASTM F2119-07(2013), ASTM F2182-10e2, ASTM F2503-20
Animal Studies
No animal data submitted.
Clinical Studies
No clinical data submitted.
VIII. CONCLUSIONS
All testing and evaluations demonstrate that the device is substantially equivalent to the predicate.
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