510(k) · Cleared
ClearedCusa NXT Extended Length Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Radionics, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Jun 10, 2011 as substantially equivalent to K021989 (Integra Neurosciences, 2002) and 3 other predicates after a 304-day review. Its family tree reaches back 5 generations to 1988. 2 later devices descend from it.
- Decided
- Jun 10, 2011
- Review
- 304 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K884413 (1988). 16 ancestors in all, the oldest K801623 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- 4 generations backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- 3 generations backK021989 Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 2002 · Recalled
- 2 generations backK042277 Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 2004
- 1 generation backK081459 Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 2008 · Recalled
- This deviceK102258 Cusa NXT Extended Length TipIntegra Radionics, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK111741 Integra (TM) Cusa NXT (TM) Bone TipsIntegra Burlington Ma, Inc. (Formerly Integra Radi · 2011
- Descendant · 2 generations on · 0 of its ownK113570 Integra Cusa NXT Inferior Foward Bone TipIntegra Burlington Ma, Inc. · 2012
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 |
|---|---|---|---|---|---|
| −5 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| −4 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| −3 | K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 | Integra Neurosciences | 2002 | 2 |
| −2 | K042277 | Selector Quantum Ultrasonic Aspirator System | Integra Neurosciences, Ltd. | 2004 | — |
| −1 | K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation System | Integra Radionics, Inc. | 2008 | 4 |
| 0 (this device) | K102258 | Cusa NXT Extended Length Tip | Integra Radionics, Inc. | 2011 | — |
| +1 | K111741 | Integra (TM) Cusa NXT (TM) Bone Tips | Integra Burlington Ma, Inc. (Formerly Integra Radi | 2011 | — |
| +2 | K113570 | Integra Cusa NXT Inferior Foward Bone Tip | Integra Burlington Ma, Inc. | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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? (4)
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 |
|---|---|---|---|
| * | K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Summary page 1…LFL 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed Selector Integra Ultrasonic Surgical Aspirator System, K02 1989 CUSA EXCEL Ultrasonic Surgical Aspirator System, K98 1262 CUSA Se… | 2002 |
| * | K981262 | Cusa Excel Ultrasonic Surgical Aspirator SystemSummary page 1…Selector Integra Ultrasonic Surgical Aspirator System, K02 1989 CUSA EXCEL Ultrasonic Surgical Aspirator System, K98 1262 CUSA Selector NXT Ultrasonic Tissue Ablation System K08 1459 Inte… | 1998 |
| * | K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation SystemSummary page 1…CUSA EXCEL Ultrasonic Surgical Aspirator System, K98 1262 CUSA Selector NXT Ultrasonic Tissue Ablation System K08 1459 Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip… | 2008 |
| * | K071669 | Integra Selector Ultrasonic Surgical Aspirator System with Bone TipSummary page 1…sonic Tissue Ablation System K08 1459 Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip K07 1669 807.92(a)(4) - Device description The Extended Length Tip (ELT) has been designed to'be used w… | 2007 |
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 |
|---|---|---|---|
| K111741 | Integra (TM) Cusa NXT (TM) Bone Tips | 2011 | 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 23 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K111741 (Integra Burlington Ma, Inc. (Formerly Integra Radi, 2011) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K021989.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that are indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery, and Thoracoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102258: Cusa NXT Extended Length Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102258
Report an extraction error
Are you the manufacturer?
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