# K221037: TruDi Shaver Blade

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Jul 20, 2022 after 104 days
- Product code: PGW (Ear, Nose, And Throat Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001284 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130608: Quadcut, Medtronic Navigation, Inc. (2013) Summary page 4.

## Indications for use
TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model. TruDi® Shaver Blades may be used in, but is not limited to, the following procedures: * Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty) * Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater * Orbital decompression * Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit * Access to the sphenoid sinus

Source page: https://510kreport.com/device/K221037
Methodology: https://510kreport.com/methodology