# K073402: Synthes Olecranon Osteotomy Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 29, 2008 after 87 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.
8 later devices descend from it; 4 cite it directly.
0 of 9 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) Pioneer Surgical Technology SS Cables with Crimp: named in the summary without a submission number
- (no number) Synthes Kirschner Wires: named in the summary without a submission number
- (no number) Synthes 6.5mm Cancellous Screws: named in the summary without a submission number
- (no number) Acumed Small Bone Locking Rod System: named in the summary without a submission number
- (no number) Biomet S.S.T- Small Bone Locking Forearm Nail: named in the summary without a submission number

## Most influential descendants
- K182783: DePuy Synthes Trauma Orthopedic Nail Implants (2018), 2 descendants of its own
- K081356: Olecranail Intramedullary Fixation System (2008), 2 descendants of its own
- K090091: Olecranail Intramedullary Fixation System (2009), 1 descendant of its own
- K253155: Fule Metallic Lockable Intramedullary Nail Systems (2026), 0 descendants of its own
- K201830: ANSER Clavicle Pin (2020), 0 descendants of its own

## Indications for use
Synthes Olecranon Osteotomy Nailing (OleON) System is intended to treat olecranon osteotomies as well as simple fractures of the olecranon.

Source page: https://510kreport.com/device/K073402
Methodology: https://510kreport.com/methodology