# K143320: Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Apr 23, 2015 after 155 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020069 (2002). 3 ancestors in all.
6 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)
- K112593: Styker Consolidated Operating Room Equipment (Core) System, Stryker Corporation (2012) Summary page 4.
- K041754: Stryker Maestro System, Stryker Corp. (2004) Summary page 4.

## Most influential descendants
- K190172: Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments (2019), 5 descendants of its own
- 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

## Recalls of this device
- Sep 5, 2024 · Class II · Z-0063-2025: May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, 
- Jun 28, 2023 · Class II · Z-0980-2025: There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).
- Jun 28, 2023 · Class II · Z-0981-2025: There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
- Jun 28, 2023 · Class II · Z-0982-2025: There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
- Jun 24, 2022 · Class II · Z-1478-2022: There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for 
- Jun 16, 2016 · Class II · Z-2205-2016: Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reac
- Jun 16, 2016 · Class II · Z-2204-2016: Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reac

## 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/Otorhinolaryngology; 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/K143320
Methodology: https://510kreport.com/methodology