# K033618: Synthes (Usa) Retrograde/Antegrade Femoral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 5, 2004 after 79 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 6 cite it directly.
0 of 31 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) Synthes Distal Femoral Nail: named in the summary without a submission number
- (no number) Synthes Cannulated Femoral Nail: named in the summary without a submission number
- (no number) DePuy ACE ART Femoral Nail: named in the summary without a submission number

## Most influential descendants
- K111056: Piccolo Composite Nailing System (2011), 15 descendants of its own
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System (2013), 14 descendants of its own
- K182307: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (2019), 8 descendants of its own
- K201346: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm (2020), 7 descendants of its own
- K192163: TTC Phantom® Intramedullary Nail System (2020), 6 descendants of its own

## Recalls of this device
- Nov 2, 2012 · Class II · Z-2058-2013: Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external 

## Indications for use
Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including: supracondylar fractures, including those with intra-articular extension ipsilateral hip/shaft fractures ipsilateral femur/tibia fractures fernoral fractures in multiple trauma patients fractures proximal to total knee arthroplasty fractures distal to a hip implant fractures in the morbidly obese fractures in osteoporotic bone impending pathologic fractures malunions and nonunions

Source page: https://510kreport.com/device/K033618
Methodology: https://510kreport.com/methodology