# K981529: Titanium Intramedullary Nail, Titanium Locking Screw

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 9, 1998 after 71 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
211 later devices descend from it; 16 cite it directly.
0 of 212 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 Antegrade and Retrograde Nails: named in the summary without a submission number
- (no number) Kuntscher Nail: named in the summary without a submission number
- (no number) Aim Antegrade Femoral, Retrograde Femoral and Tibial Nails: named in the summary without a submission number
- (no number) Unreamed Femoral (URFN) and Tibial Nails: named in the summary without a submission number
- (no number) Retrograde Femoral Nail: named in the summary without a submission number
- (no number) Ace ART Femoral Nail: 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
- K013563: Long Trochanteric Nail System (2001), 70 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

## Recalls of this device
- Feb 7, 2013 · Class II · Z-0943-2013: 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.
- Feb 7, 2013 · Class II · Z-0944-2013: 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.

## 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 (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shafi/neck fractures; and intertrochanteric fractures. In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach (i.e. Retrograde/Tibial and Supracondylar Nails) 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.

Source page: https://510kreport.com/device/K981529
Methodology: https://510kreport.com/methodology