# K102743: Ortho Solutions - Sterile, Drills, Taps, Guide Pins & Wires

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Solutions Limited
- Decided: Jan 20, 2011 after 120 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
Longest line of descent: 1 generation back to K962913 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962913: Synthes Sterile Drill Bits, Synthes (Usa) (1996) Summary page 1.

## Indications for use
Ortho Solutions 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/K102743
Methodology: https://510kreport.com/methodology