Smith & Nephew, Inc. · Class II · Cleared Jun 12, 2025
| K-number | K243608 |
| Device name | TRIGEN Stable Lock Nut & Washer |
| Applicant | Smith & Nephew, Inc. |
| Product code | JDS |
| Device class | Class II |
| Decision date | Jun 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The TRIGEN Stable Lock Nut & Washer is a metallic bone fixation accessory made from Ti-6Al-4V material, designed for use with three femoral nailing systems (META-TAN, TAN FAN, and META-NAIL Retrograde). It functions as an aid to normal fracture healing for proximal femur fractures, including simple, comminuted, spiral, and segmental fractures, as well as subtrochanteric, intertrochanteric, and intracapsular fractures.
The device has overall design similarity to the predicate Stainless-Steel Stable Lock Nut & Washer (K983942), but differs in material composition (Ti-6Al-4V instead of stainless steel) and thread design. The material and thread characteristics are comparable to the TRIGEN Low Profile Screw predicate (K111025).
ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, and ASTM F2119-07(2013) for MR Compatibility; theoretical failure analysis and torque to failure/insertion/extraction torque testing.
The subject device falls within the indications for use of its predicate devices and combines design elements from two predicates—structural/functional similarity to K983942 and material/thread properties similar to K111025. Bench testing (failure analysis, torque testing, and MR compatibility) demonstrated that the differences in material and thread design do not raise any safety or effectiveness concerns compared to the predicates, establishing substantial equivalence without clinical data.
View the full FDA submission: accessdata.fda.gov