# K040212: Trigen Intertan

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 20, 2004 after 21 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981529 (1998). 5 ancestors in all.
121 later devices descend from it; 17 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981529: Titanium Intramedullary Nail, Titanium Locking Screw, Smith & Nephew, Inc. (1998) Summary page 1.
- K993289: Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System, Smith & Nephew, Inc. (1999) Summary page 1.
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap, Smith & Nephew, Inc. (1998) Summary page 1.
- K013524: Trochanteric Dyax Nail System, Howmedica Osteonics Corp. (2001) Summary page 1.
- K010780: Trochanteric Nail, DePuy Orthopaedics, Inc. (2001) Summary page 1.

## Most influential descendants
- K051557: Trigen Retrograde Femoral, Supracondylar and Tibial Nails (2005), 69 descendants of its own
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails (2006), 60 descendants of its own
- K080434: Intertan CHS Locking Plate System Prox Fem Plates/Screw (2008), 35 descendants of its own
- K090656: Intertan CHS Limited Collapse Set Screw (2009), 34 descendants of its own
- K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation (2013), 33 descendants of its own

## Recalls of this device
- Apr 22, 2022 · Class II · Z-1133-2022: Right nails were anodized, marked, and labelled as left nails and vice versa
- Nov 2, 2020 · Class II · Z-0772-2021: Manufacturing packaging error.
- Oct 24, 2017 · Class II · Z-0097-2018: A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
- Jul 2, 2014 · Class II · Z-2258-2014: There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS.
- Apr 4, 2014 · Class II · Z-1636-2014: A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
- Apr 4, 2014 · Class II · Z-1637-2014: A manufacturing error resulted in the set screw being inserted too deep in the affected nails.

## Indications for use
InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. InterTAN nail is for single use only.

Source page: https://510kreport.com/device/K040212
Methodology: https://510kreport.com/methodology