# K041413: XPS 3000 System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Jul 12, 2004 after 46 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002224 (2000). 1 ancestor in all.
453 later devices descend from it; 5 cite it directly.
1 of 455 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002224: XPS 3000 System, Medtronic Xomed (2000) Summary page 3.

## Most influential descendants
- K073255: XPS 3000 System (2008), 448 descendants of its own
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] (2008), 443 descendants of its own
- K081277: XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) (2008), 420 descendants of its own
- K111520: Ipc Powerease System (2011), 418 descendants of its own
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps (2013), 404 descendants of its own

## Indications for use
The XPS 3000 is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery. Otology / neurotology indications include mastoidectomy, mastoidotomy, and acoustic neuroma. Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-spheniodal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidotomy, and medial, lateral, and posterior frontal sinusotomy. Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, tonsillectomy, tonsillotomy for obstructive tonsillar disease, removal of endobronchial lesions, and the surgical management of recurrent respiratory papillomatosis (RRP). Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery. The XPS 3000 system using the PowerSculpt handpiece and reciprocating cutting blades / rasps is indicated to cut hard and soft tissue or bone in otorhinolaryngology and head and neck surgery. The XPS 3000 system with reciprocating adapter and suction cannula is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring. The XPS 3000 system is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is required. These include spinal and small and large joint arthroscopic procedures. An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.

Source page: https://510kreport.com/device/K041413
Methodology: https://510kreport.com/methodology