AMF TT Cones
by Lima Corporate S.P.A. 510(k)
Active
510(k) K234011
Overview
The AMF TT Cones are classified as a Knee Joint Patellofemoral Polymer Semi-Constrained Cemented Prosthesis (Product Code: JWH), designed as an orthopedic implant for use in total knee arthroplasty procedures. These cones serve as an integral component in the fixation of tibial components, providing stability and alignment within the knee joint. Constructed for cemented application, they are intended to interface with femoral and tibial implants to restore function and mobility in affected joints.
The AMF TT Cones are supplied as a sterile, single-use device, intended for surgical use in controlled clinical environments. They are regulated under FDA 510(k) clearance (K234011) and fall under the Special 510(k) pathway, with a decision classification of Substantially Equivalent (SESE) to predicate devices. Compliance with 21 CFR 888.3560 ensures adherence to orthopedic implant standards. Storage and handling must follow sterile medical device protocols to maintain integrity prior to surgical use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK234011 | Date18 Jan 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Other devices from Lima Corporate S.P.A.
Questions
What is the AMF TT Cones used for in knee surgery?
The AMF TT Cones are designed as a cemented patellofemoral polymer semi-constrained prosthesis for total knee arthroplasty. They serve as a critical component in securing tibial implants, enhancing joint stability and alignment to restore function and mobility in affected knees. Their semi-constrained design helps maintain proper tracking of the patella while allowing controlled movement, making them ideal for patients requiring moderate constraint in their knee replacement.
How are the AMF TT Cones supplied and prepared for surgery?
The AMF TT Cones are supplied as sterile, single-use devices, packaged for surgical use in controlled environments. They are intended to be used once per patient and must remain unopened until immediately before surgery. Sterility is maintained through manufacturer-provided packaging, and proper handling—including avoiding contamination—is essential to preserve their integrity prior to implantation. Always follow sterile medical device protocols during storage and preparation.
Are the AMF TT Cones reusable or intended for single-patient use?
The AMF TT Cones are strictly single-use devices, meaning each cone is intended for one surgical procedure only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, structural integrity, or patient safety. Adherence to single-use guidelines ensures compliance with FDA 510(k) requirements and maintains the device’s performance standards for optimal clinical outcomes.
What regulatory pathway does the AMF TT Cones follow, and what does that mean for clinicians?
The AMF TT Cones are cleared under the FDA 510(k) Special pathway, specifically classified as Substantially Equivalent (SESE) to predicate devices. This means the device has been evaluated by the FDA’s Orthopedic (OR) Advisory Committee and determined to have the same intended use, technological characteristics, and performance as a previously cleared product. Clinicians can rely on this classification as evidence of the device’s safety and effectiveness for cemented tibial fixation in total knee arthroplasty, though they should always verify the latest regulatory status before use.
How should the AMF TT Cones be stored to ensure they remain usable?
The AMF TT Cones must be stored in their original, unopened sterile packaging in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. Storage should comply with standard sterile medical device protocols to prevent contamination or damage. If the packaging is compromised, the device should be discarded immediately. Always check expiration dates and storage conditions before use to ensure optimal performance during surgery.