(59 days)
No
The document describes a mechanical hip implant and its performance testing, with no mention of AI or ML in its design, function, or intended use.
Yes
The device is a hip joint prosthesis intended to replace a hip joint for patients suffering from various medical conditions, including noninflammatory degenerative joint disease, rheumatoid arthritis, and femoral fracture, which are conditions that benefit from therapeutic intervention.
No
The device described is a hip joint prosthesis, which is an implant used for replacement, not a device used to diagnose a medical condition.
No
The device description clearly describes a physical implant (femoral stem) intended for surgical implantation, not a software-only product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a hip joint metal uncemented prosthesis, which is an implantable medical device used to replace a damaged hip joint.
- Intended Use: The intended use is to replace a hip joint in patients with various conditions affecting the hip. This is a surgical intervention, not a diagnostic test performed on a specimen.
The device is a physical implant used in surgery, not a tool for analyzing biological samples.
N/A
Intended Use / Indications for Use
The hip joint metal uncemented prosthesis is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis;
- correction of functional deformity;
- femoral fracture; and
- revision procedures where other treatments or devices have failed.
This stem is to be press-fit. This stem is intended for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, KWY, KWZ
Device Description
The EMPOWR™ blade stem represents the latest generation of a press-fit, porous coated, wedge style femoral stem. Building on the design principles of its predicate, Linear® Hip Stem, the EMPOWR™ blade stem system features enhancements such as addition of coxa vara offset, neck angle update, and distal angle reduction for wider application.
The EMPOWR™ blade stem is applicable for use in total hip arthroplasty and the prosthetic replacement of femoral neck fractures in all age groups. It offers a stem design with a reproducible surgical technique carefully developed to enable consistent and accurate implantation. The EMPOWR™ blade stem features streamlined and accurate instrumentation that is highly adaptable to any surgical approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, natural femoral head, femoral neck
Indicated Patient Age Range
all age groups
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 was completed on the subject EMPOWR™ blade stem and is detailed in the Performance Testing section. The following testing was performed to FDA recognized standards and internal protocols that is specific to the EMPOWR™ blade stem:
- CAD Based Range of Motion (ROM) ISO 21535:2007
- Distal Stem Fatigue Testing – ISO 7206-4:2010
- Neck Stem Fatigue Testing ISO 7206-6:2013
All testing and evaluations demonstrate that the subject device is substantially equivalent to the predicate devices.
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.
Enovis™ Linear® Hip Stem, K120241
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.
Zimmer Biomet™ TaperLoc® Complete Stem, K120030
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
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February 13, 2023
Encore Medical LLC Trev Thorsen Regulatory Affairs 9800 Metric Blvd Ste 200 Austin, Texas 78758
Re: K223779
Trade/Device Name: EMPOWR™ blade stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, LZO, KWY, KWZ Dated: December 15, 2022 Received: December 16, 2022
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.
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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) 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 medical devices and radiation-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,
Christopher Ferreira -S
for
Limin Sun, Ph.D. 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K223779
Device Name EMPOWR™ blade stem
Indications for Use (Describe)
The hip joint metal uncemented prosthesis is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the . natural femoral head;
- . rheumatoid arthritis;
- . correction of functional deformity;
- femoral fracture; and .
- . revision procedures where other treatments or devices have failed.
This stem is to be press-fit. This stem is intended for cementless use.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/1 description: The image shows the logo for "enovis". The word "enovis" is written in a stylized font, with the "e", "n", and the first part of the "o" in red. The second part of the "o" is a black circle with a gradient effect, and the "vis" is in black. There is a trademark symbol to the bottom right of the logo.
510(k) Summary
14DEC2022
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™ blade stem Common or Usual Name: Total Hip Implant Classification Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis – 21 CFR 888.3358 Regulatory Class: II Primary Product Code: LPH
Secondary Product Code: LZO, KWY, KWY, KWZ
III. PREDICATE DEVICE
Primary Predicate: Enovis™ Linear® Hip Stem, K120241 Reference Predicate: Zimmer Biomet™ TaperLoc® Complete Stem, K120030
IV. DEVICE DESCRIPTION
The EMPOWR™ blade stem represents the latest generation of a press-fit, porous coated, wedge style femoral stem. Building on the design principles of its predicate, Linear® Hip Stem, the EMPOWR™ blade stem system features enhancements such as addition of coxa vara offset, neck angle update, and distal angle reduction for wider application.
The EMPOWR™ blade stem is applicable for use in total hip arthroplasty and the prosthetic replacement of femoral neck fractures in all age groups. It offers a stem design with a reproducible surgical technique carefully developed to enable consistent and accurate implantation. The EMPOWR™ blade stem features streamlined and accurate instrumentation that is highly adaptable to any surgical approach.
V. INTENDED USE/INDICATIONS FOR USE
Intended Use:
Enovis™ hip devices are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use. While hip 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.
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Image /page/4/Picture/1 description: The image shows the logo for "enovis". The "eno" portion of the logo is red, while the "o" is stylized as a black and grey ring. The "vis" portion of the logo is black, and the trademark symbol is in the lower right corner.
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Indications for Use:
The hip joint metal uncemented prosthesis is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the ● natural femoral head;
- rheumatoid arthritis;
- correction of functional deformity;
- femoral fracture; and
- revision procedures where other treatments or devices have failed.
This stem is to be press-fit. This stem is intended for cementless use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The EMPOWR™ blade stem and accessories are technologically the same when compared to the predicate Linear Hip Stem (cleared via K120241). Comparative testing demonstrates substantial equivalence between the subject and predicate device. The stem trunnions and the porous titanium coating are identical between the subject and predicate device.
There is a slight difference between the subject device ("EMPOWR™ blade stem") indications for use and the predicate device, Linear® stem ("Linear®") (K120241) indications for use statement. The added statements are for clarity and do not change the overall intent of the indications.
The subject EMPOWR™ blade stem has one size smaller and one size larger than the predicate Enovis™ Linear® stem. The subject EMPOWR™ blade stem has two fewer sizes than the predicate Biomet® TaperLoc® Complete stem. The smallest size is equivalent between the two systems. The largest subject stem is not larger than the largest Biomet® TaperLoc® Complete stem. The size offering for the subject device is within the size offering of the predicate Biomet® TaperLoc® Complete stem offering.
The component compatibility of the EMPOWR™ blade stem is identical to the Linear® stem (K120241) as femoral stems are compatible with all Enovis™ femoral heads and acetabular systems, including Encore® previously cleared FMP® and EMPOWR™ semi constrained acetabular shells, previously cleared femoral heads, previously cleared unipolar heads/sleeves, EMPOWR™ dual mobility and mobility system, bipolar systems, and FMP® constrained system.
Biocompatibility testing
The biocompatibility evaluation for the EMPOWR™ blade stem 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.
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The EMPOWR™ blade stem is intended for permanent implantation, contacting tissue/bone. Biocompatibility was ensured through the use of qualified materials and contact agents.
Performance Testing
Performance testing was completed on the subject EMPOWR™ blade stem and is detailed in the Performance Testing section. The following testing was performed to FDA recognized standards and internal protocols that is specific to the EMPOWR™ blade stem:
- CAD Based Range of Motion (ROM) ISO 21535:2007 ●
- Distal Stem Fatigue Testing – ISO 7206-4:2010
- Neck Stem Fatigue Testing ISO 7206-6:2013 ●
Animal Studies
No animal data submitted.
Clinical Studies No clinical data submitted.
VIII. CONCLUSIONS
All testing and evaluations demonstrate that the subject device is substantially equivalent to the predicate devices.