# K190172: Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Jun 14, 2019 after 133 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K020069 (2002). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143320: Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments, Stryker Corp. (2015) Summary page 5.

## Most influential descendants
- K241171: Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories (2024), 4 descendants of its own
- K241517: Q Guidance System; Mako Spine System; (2024), 2 descendants of its own
- K252871: Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories (2026), 1 descendant of its own
- K253623: Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor (2026), 0 descendants of its own
- K243958: Consolidated Operating Room Equipment (CORE) 2 Console (2025), 0 descendants of its own

## Indications for use
The Elite and Heavy Duty Attachments 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 Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone and bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otorhinolaryngotorhinolaryngology; Craniofacial and Maxillofacial; Dental; and Endoscopic applications. The specific applications include Craniotomy/Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, segmenting, splitting, fragmenting, extracting, removing, drilling, and reaming. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, deburring, smoothing or shaping of metal, and removing/rounding sharp edges.

Source page: https://510kreport.com/device/K190172
Methodology: https://510kreport.com/methodology