# K143399: Stryker Footed Attachments and Cutting Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: May 8, 2015 after 161 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- 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: 1 generation back to K112593 (2012). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112593: Styker Consolidated Operating Room Equipment (Core) System, Stryker Corporation (2012) Summary page 4.

## Most influential descendants
- K191049: Stryker MIS and Footed Attachments (2019), 0 descendants of its own

## Recalls of this device
- Jun 24, 2016 · Class II · Z-2238-2016: A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft tissue requiring

## Indications for use
The Footed Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT) / Otology /Neurotology/Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy. Specific applications include Craniotomy/Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy/Laminectomy, and Orthopedic Spine. These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.

Source page: https://510kreport.com/device/K143399
Methodology: https://510kreport.com/methodology