# K221235: neXus Ultrasonic Surgical Aspirator System

- Pathway: 510(k) (Traditional)
- Applicant: Misonix, Inc.
- Decided: Jul 28, 2022 after 90 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K884413 (1988). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200774: CUSA Clarity Ultrasonic Surgical Aspirator System, Integra LifeSciences Corporation (2020) Summary page 6.

## Most influential descendants
- K231117: neXus Ultrasonic Surgical Aspirator System (2023), 1 descendant of its own
- K261448: neXus Ultrasonic Surgical Aspirator System (2026), 0 descendants of its own

## Indications for use
The Misonix Inc. neXus Ultrasonic Surgical Aspirator System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue. The indications for use for the Standard Handpiece in combination with BoneScalpel and SonicOne OR probe kit accessory configurations, the SonaStar®long and short handpieces in combination with SonaStar probe kit accessory configurations, the BoneScalpel AccessTM handpiece with BoneScalpel AccessTM probe kit accessory configurations, and the SonaStar Elite Handpiece with probe kit accessory configurations are listed below. Standard Handpiece with BoneScalpel Probe Kits Indicated for use in the fragmentation, emulsification and aspiration of soft and hard (e.g., bone) tissue in the following surgical specialties: • Neurosurgery • Gastrointestinal and Affiliated Organ Surgery • Urological Surgery • Plastic and Reconstructive Surgery • General Surgery • Orthopedic Surgery • Gynecology External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids. • Thoracic Surgery Limited pulmonary resection such as segmentectomies, nonanatomical subsegmentectomies and metastatectomies. • Wound Care The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. Standard Handpiece with SonicOne Probe Kits Indicated for use in the fragmentation, emulsification and aspiration of soft and hard tissue (i.e. bone) in the following surgical specialty: • Wound Care The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. • Plastic and Reconstructive Surgery neXus SonaStar Handpieces with SonaStar Probe Kits • Indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties: • Neurosurgery • Gastrointestinal and Affiliated Organ Surgery – including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy • Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy • Plastic and Reconstructive Surgery • General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures • Orthopedic Surgery • Gynecological Surgery – except as contraindicated for uterine fibroids. • Thoracic Surgery • Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy • Thoracoscopic Surgery The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components. Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kits Indicated for use in the fragmentation and aspiration of soft and hard (e.g.: bone) tissue in the following surgical specialties: • Neurosurgery • Gastrointestinal and Affiliated Organ Surgery • Urological Surgery • Plastic and Reconstructive Surgery • General Surgery • Orthopedic Surgery • Gynecology External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids. • Thoracic Surgery Limited pulmonary resection such as segmentectomies, nonanatomical subsegmentectomies and metastatectomies. SonaStar Elite Handpiece with SonaStar Elite Probe Kits Indicated for use in the fragmentation and aspiration of soft and hard (e.g., bone) tissue in the following surgical specialties: • Neurosurgery • Gastrointestinal and Affiliated Organ Surgery – including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy • Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy • Plastic and Reconstructive Surgery • General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures • Orthopedic Surgery • Gynecological Surgery – except as contraindicated for uterine fibroids. • Thoracic Surgery • Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy • Thoracoscopic Surgery The system may also be combined with electrosurgery using optional RF surgery interface components.

Source page: https://510kreport.com/device/K221235
Methodology: https://510kreport.com/methodology