# K153587: Taps for Resorbable Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Jan 18, 2017 after 399 days
- Product code: HBG (Drills, Burrs, Trephines & Accessories (Manual))
- Device class: 2
- Regulation: 21 CFR 882.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K862807 (1986). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123270: Powerease System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4.

## Indications for use
Taps are nonpowered hand-held devices intended for bone cutting and drilling on a patient’s skull during fracture repair and reconstructive procedures of the cranium. The taps may be used to prepare cranial bone to insert bone fixation screws.

Source page: https://510kreport.com/device/K153587
Methodology: https://510kreport.com/methodology