# K983942: Intramedullary Nail System, Locking Screw, Nail Cap

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 4, 1998 after 29 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
198 later devices descend from it; 18 cite it directly.
0 of 199 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) Trimax Nail System: named in the summary without a submission number

## Most influential descendants
- K040212: Trigen Intertan (2004), 121 descendants of its own
- K032722: Trigen Straight Humeral Nail System (2003), 100 descendants of its own
- 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
- K023115: Ace Versanail (2002), 41 descendants of its own

## Indications for use
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants. Indications for the ReVision Nail include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint. Knee Fusion Nails are intended for intramedullary knee arthrodesis. Ender Nails are indicated as follows: fracture of the neck, trochanteric, and subtrochanteric region of the femur; distal femoral fractures with a distal fragment 10 cm or longer; tibial shaft fractures; and proximal humeral fractures.

Source page: https://510kreport.com/device/K983942
Methodology: https://510kreport.com/methodology