# K964163: Trimax Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Dec 27, 1996 after 71 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ZMS Intramedullary Fixation System (Zimmer): named in the summary without a submission number
- (no number) Grosse & Kempf Locking Nail (Howmedica): named in the summary without a submission number
- (no number) Retrograde Femoral Nail (Biomet): named in the summary without a submission number
- (no number) Aim Titanium Supracondylar Nail (Ace): named in the summary without a submission number
- (no number) Alta Nail (Howmedica): named in the summary without a submission number
- (no number) Femoral Nail System (Synthes): named in the summary without a submission number

## Most influential descendants
- K122170: Smith & Nephew, Inc. Intramedullary Nail System Instrumentation (2012), 0 descendants of its own

## Indications for use
Femoral/recon antegrade nails and retrograde nails are indicated for shaft fractures including severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; bone lengthening/shortening; femur reconstruction following tumor resection and grafting; fractures in osteoporotic bone; severely comminuted shaft fractures; pathologic fractures, pseudoarthrosis, failed osteosynthesis; closed supracondylar fractures; and prophylactic nailing of impending pathologic fractures. Additional indications for the femoral/recon antegrade include: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures. Additional indications for retrograde nails include: severely comminuted supracondylar fractures with or without difficult intra-articular extension, fractures that require opening the knee joint to stabilize the femoral condylar segment. Also, fractures above total knee implants. The TriMax Nail System is intended to be removed upon fracture healing.

Source page: https://510kreport.com/device/K964163
Methodology: https://510kreport.com/methodology