# K082010: Stryker Disposable Cranial Perforator Bit

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Ireland Ltd., Instruments Division
- Decided: Dec 29, 2008 after 167 days
- Product code: HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4305
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K791101 (1979). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892866: Automatic Cranial Drill (Perforator), Acra Cut, Inc. (1989) Summary page 1.
- K071931: Codman Disposable Perforator, Model (S) 26-1222, 26-1223, Codman & Shurtleff, Inc. (2007) Summary page 1.

## Most influential descendants
- K141455: Easydrill Autostop Cranial Perforator (2015), 0 descendants of its own

## Recalls of this device
- Oct 16, 2020 · Class II · Z-0431-2021: Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.

## Indications for use
The Stryker Zyphr TM Disposable Cranial Perforator Large 14/11mm (perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick. The Stryker Zyphr TM Disposable Cranial Perforator Small 11/7mm (perforator) is a sterile, single use cutting accessory intended for cutting a 7 mm diameter access hole through the cranium of adult and pediatric patients. It is intended for thin bone that is at least 1mm thick.

Source page: https://510kreport.com/device/K082010
Methodology: https://510kreport.com/methodology