510(k) · Cleared
ClearedESPIN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nlt Spine, Ltd. · HRX Arthroscope
Cleared on Aug 9, 2012 as substantially equivalent to K110992 (Spine View, Inc., 2011) after a 168-day review. Its family tree reaches back 7 generations to 1999. 2 later devices descend from it.
- Decided
- Aug 9, 2012
- Review
- 168 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K991794 (1999). 27 ancestors in all, the oldest K844131 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
- 6 generations backK021748 Endius Atavi SystemEndius, Inc. · 2002
- 5 generations backK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- 4 generations backK061345 Modification to Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- 3 generations backK081051 Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008
- 2 generations backK090278 Enspire Debrider SystemSpine View, Inc. · 2009
- 1 generation backK110992 Enspire Debrider SystemSpine View, Inc. · 2011
- This deviceK120553 ESPINNlt Spine, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK130057 ESPINNlt Spine, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK133061 Espin SystemNlt Spine, Ltd. · 2013
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 |
|---|---|---|---|---|---|
| −7 | K991794 | Endoscopic Spinal Access System | Endius, Inc. | 1999 | — |
| −6 | K021748 | Endius Atavi System | Endius, Inc. | 2002 | — |
| −5 | K053267 | Endius Atavi System | Endius, Inc. | 2006 | 1 |
| −4 | K061345 | Modification to Endius Atavi System | Endius, Inc. | 2006 | 1 |
| −3 | K081051 | Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope | Spine View, Inc. | 2008 | — |
| −2 | K090278 | Enspire Debrider System | Spine View, Inc. | 2009 | — |
| −1 | K110992 | Enspire Debrider System | Spine View, Inc. | 2011 | — |
| 0 (this device) | K120553 | ESPIN | Nlt Spine, Ltd. | 2012 | — |
| +1 | K130057 | ESPIN | Nlt Spine, Ltd. | 2013 | — |
| +1 | K133061 | Espin System | Nlt Spine, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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 |
|---|---|---|---|
| * | K110992 | Enspire Debrider SystemSummary page 1…sories 21 CFR §888.l100 Product Code HRX Predicate Devices Spine View enSpire Discectomy System (KiI110992) Intended Use I Indications for Use The eSpin is intended for use in cutting and grinding intervertebral disc material during… | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 27 ancestors have a recall of any class.
- Of its descendants, K130057 (Nlt Spine, Ltd., 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K110992.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The eSpin is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DOD). DD is defined as back pain of disclagenic origin with degeneration of the disc confirmed by the history and radiographic studies. DOD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120553: ESPIN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120553
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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