GENOLL Total Knee System
510(k) K191192
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191192 | Date1 Aug 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- SurgTech GENOLL Total Knee System
- 510(k) Number
- FDA Product Code
- JWH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The GENOLL Total Knee System is a Total Knee Prosthesis (Device Type: JWH) designed for primary total knee arthroplasty. It replaces damaged knee joint surfaces to restore alignment, reduce pain, and improve mobility in skeletally mature patients with degenerative or traumatic joint conditions. The system includes modular components such as the femoral component, tibial baseplate, tibial insert, and patella, engineered for anatomical fit and functional restoration.
This system is intended for surgical use in orthopedic settings and is supplied as a sterile, single-use device. Components are MRI-unsafe due to metallic construction and must be handled per manufacturer guidelines. Sizes and configurations align with standard total knee arthroplasty protocols, and the device holds FDA 510(k) clearance (K191192) under the Orthopedic Advisory Committee. Storage and handling follow aseptic protocols to maintain sterility.
Other devices from Surgtech, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of knee conditions is the SurgTech GENOLL Total Knee System intended to address in patients?
The SurgTech GENOLL Total Knee System is designed for primary total knee arthroplasty in skeletally mature patients with degenerative or traumatic joint conditions. It replaces damaged knee joint surfaces to restore alignment, alleviate pain, and enhance mobility, making it suitable for severe osteoarthritis or post-traumatic knee damage where conservative treatments have failed.
Is the SurgTech GENOLL Total Knee System reusable, or is it meant for single-use only?
The SurgTech GENOLL Total Knee System is explicitly supplied as a sterile, single-use device. This ensures patient safety and reduces the risk of cross-contamination, aligning with standard aseptic protocols for orthopedic implants.
Can this device be used in MRI scans, or does it contain materials that interfere with imaging?
No, the SurgTech GENOLL Total Knee System is not MRI-safe due to its metallic construction. The components contain materials that would distort MRI images, so patients with this implant should avoid MRI procedures unless specifically cleared by their physician.
How should the SurgTech GENOLL Total Knee System be stored to maintain its sterility?
The device must be stored following aseptic protocols to preserve sterility. Since it is single-use, it should remain in its original packaging until immediately before use, in a clean, dry environment protected from contamination, as outlined in the manufacturer’s handling guidelines.
What regulatory pathway was followed for FDA clearance of the SurgTech GENOLL Total Knee System?
The SurgTech GENOLL Total Knee System received FDA clearance through a 510(k) submission, specifically under the Traditional review pathway. It was deemed substantially equivalent to a predicate device and reviewed by the Orthopedic Advisory Committee (OR) with clearance number K191192.