EMPOWR Blade Stem
510(k) K223779
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223779 | Date13 Feb 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LPH
- FDA applicant
- Encore Medical, LLC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Empowr Blade Stem is a press-fit orthopedic device designed for use in total knee arthroplasty. It features a blade geometry intended to enhance anterior-posterior filling and stability within the femur, aiding in long-term implant fixation. This device is categorized under product code LPH and is classified as a Class II orthopedic implant.
Intended for surgical use, the Empowr Blade Stem is supplied as a reusable instrument component within a single-tray instrumentation system. It requires sterile handling and is cleared for use in orthopedic procedures under FDA 510(k) authorization (K223779). The device is manufactured by Encore Medical, LLC, and adheres to traditional 510(k) review standards, with no explicit MRI safety or sterility specifications noted beyond standard surgical instrument requirements.
Other devices from Encore Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Empowr Blade Stem used for in total knee arthroplasty?
The Empowr Blade Stem is a press-fit orthopedic device specifically designed for use in total knee arthroplasty. Its blade geometry is engineered to enhance anterior-posterior filling and stability within the femur, which helps improve long-term implant fixation. This ensures better alignment and support during knee replacement surgeries, contributing to the overall success and longevity of the arthroplasty.
How is the Empowr Blade Stem supplied, and what are the handling requirements?
The Empowr Blade Stem is supplied as a reusable component within a single-tray instrumentation system. Since it is intended for surgical use, it must be handled under sterile conditions to prevent contamination. Proper sterilization and storage protocols must be followed to maintain its integrity and functionality for repeated use in orthopedic procedures.
Is the Empowr Blade Stem single-use or reusable?
The Empowr Blade Stem is designed as a reusable instrument component. It is included in a single-tray instrumentation system, allowing for multiple uses across different surgical procedures. However, it must be sterilized between uses to ensure safety and compliance with surgical standards.
Are there any specific storage instructions for the Empowr Blade Stem?
While the device data does not specify unique storage instructions beyond standard surgical instrument requirements, it is critical to store the Empowr Blade Stem in a clean, dry environment to prevent damage or contamination. Follow manufacturer guidelines for packaging and storage to maintain its sterility and functionality for reuse in orthopedic surgeries.
What regulatory pathway does the Empowr Blade Stem follow?
The Empowr Blade Stem is cleared for use under FDA 510(k) authorization (K223779) and follows the traditional 510(k) review pathway. This means it has been determined to be substantially equivalent to a legally marketed device that was not required to undergo premarket approval. The device is classified under product code LPH and is categorized as a Class II orthopedic implant.