# K962913: Synthes Sterile Drill Bits

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 14, 1996 after 111 days
- Product code: HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 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 no predicate by number.

## Most influential descendants
- K161704: Phasor Drill (2016), 4 descendants of its own
- K122455: Synthes Small External Fixation System, Synthes Large External Fixation System (2013), 3 descendants of its own
- K230619: Hubly Electric Drill (H100) (2023), 1 descendant 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
- K252696: Legacy (2025), 0 descendants of its own

## Indications for use
Synthes Sterile Drill Bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

Source page: https://510kreport.com/device/K962913
Methodology: https://510kreport.com/methodology