# K040701: Synthes (Usa) Hydroxyapatite (HA) Coated Schanz Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jun 15, 2004 after 90 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 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 Schanz Screws: named in the summary without a submission number
- (no number) Smith & Nephew Jet-X Half Pin: named in the summary without a submission number

## Most influential descendants
- K122455: Synthes Small External Fixation System, Synthes Large External Fixation System (2013), 3 descendants of its own
- K141912: Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon (2014), 1 descendant of its own
- K250315: Ronavis – FX (FX-001) (2025), 0 descendants of its own
- K232897: Arthrex Small External Fixation System (2023), 0 descendants of its own
- K171911: Medline ReNewal Reprocessed Synthes External Fixation Systems (2017), 0 descendants of its own

## Indications for use
Synthes Hydroxyapatite (HA) Coated Schanz Screws are intended for use with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

Source page: https://510kreport.com/device/K040701
Methodology: https://510kreport.com/methodology