# K002729: Synthes Proximal Humeral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 6, 2000 after 35 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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 (USA) Unreamed Humeral Nail: named in the summary without a submission number
- (no number) Acumed Polarus Proximal Humeral Fixation Rod: named in the summary without a submission number

## Most influential descendants
- K182783: DePuy Synthes Trauma Orthopedic Nail Implants (2018), 2 descendants 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
The Synthes Proximal Humeral Nail is indicated for use in fractures of the proximal humerus.

Source page: https://510kreport.com/device/K002729
Methodology: https://510kreport.com/methodology