510(k) · Cleared
ClearedneXus Ultrasonic Surgical Aspirator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Misonix, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Jul 28, 2022 as substantially equivalent to K200774 (Integra LifeSciences Corporation, 2020) after a 90-day review. Its family tree reaches back 8 generations to 1988. 2 later devices descend from it.
- Decided
- Jul 28, 2022
- Review
- 90 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K884413 (1988). 20 ancestors in all, the oldest K801623 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- 7 generations backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- 6 generations backK021989 Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 2002 · Recalled
- 5 generations backK042277 Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 2004
- 4 generations backK081459 Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 2008 · Recalled
- 3 generations backK161882 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2016 · Recalled
- 2 generations backK182809 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2018 · Recalled
- 1 generation backK200774 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2020
- This deviceK221235 neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK231117 neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC, A Bioventus Company · 2023
- Descendant · 2 generations on · 0 of its ownK261448 neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| −7 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| −6 | K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 | Integra Neurosciences | 2002 | 2 |
| −5 | K042277 | Selector Quantum Ultrasonic Aspirator System | Integra Neurosciences, Ltd. | 2004 | — |
| −4 | K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation System | Integra Radionics, Inc. | 2008 | 4 |
| −3 | K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2016 | 2 |
| −2 | K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2018 | 42 |
| −1 | K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2020 | — |
| 0 (this device) | K221235 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2022 | — |
| +1 | K231117 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC, A Bioventus Company | 2023 | — |
| +2 | K261448 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LFL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LFL device
- #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200774 | CUSA Clarity Ultrasonic Surgical Aspirator SystemSummary page 6…tion Name: Unclassified Regulatory Class: Unclassified Product Code: LFL, GEI, LBK 2. PREDICATE DEVICE Predicate Device: K200774, CUSA Clarity Ultrasonic Aspirator System, Integra LifeSciences Reference K212960, neXus Ultrason… | 2020 |
| † | K212960 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 | 2022 |
| † | K190160 | neXus Ultrasonic Surgical Aspirator System | 2019 |
| † | K212060 | neXus Ultrasonic Surgical Aspirator System | 2021 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231117 | neXus Ultrasonic Surgical Aspirator System | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K231117 (Misonix, LLC, A Bioventus Company, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K200774.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
MAUDE reports naming product code LFL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
What is it indicated for?
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…
Read the full statement (867 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221235 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221235: neXus Ultrasonic Surgical Aspirator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221235
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026