510(k) · Cleared
ClearedEspin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nlt Spine, Ltd. · HRX Arthroscope
Cleared on Nov 27, 2013 as substantially equivalent to K120553 (Nlt Spine, Ltd., 2012) and 2 other predicates after a 61-day review. Its family tree reaches back 9 generations to 1999.
- Decided
- Nov 27, 2013
- Review
- 61 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K991794 (1999). 56 ancestors in all, the oldest K844131 (1984). No later device cites it as a predicate yet.
- Root · 9 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
- 5 generations between
- 3 generations backK110992 Enspire Debrider SystemSpine View, Inc. · 2011
- 2 generations backK120553 ESPINNlt Spine, Ltd. · 2012
- 1 generation backK130057 ESPINNlt Spine, Ltd. · 2013
- This deviceK133061 Espin SystemNlt Spine, Ltd. · 2013
Show all 9 generations
- Root · 9 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
- 8 generations backK021748 Endius Atavi SystemEndius, Inc. · 2002
- 7 generations backK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- 6 generations backK061345 Modification to Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- 5 generations backK081051 Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008
- 4 generations backK090278 Enspire Debrider SystemSpine View, Inc. · 2009
- 3 generations backK110992 Enspire Debrider SystemSpine View, Inc. · 2011
- 2 generations backK120553 ESPINNlt Spine, Ltd. · 2012
- 1 generation backK130057 ESPINNlt Spine, Ltd. · 2013
- This deviceK133061 Espin SystemNlt Spine, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K991794 | Endoscopic Spinal Access System | Endius, Inc. | 1999 | — |
| −8 | K021748 | Endius Atavi System | Endius, Inc. | 2002 | — |
| −7 | K053267 | Endius Atavi System | Endius, Inc. | 2006 | 1 |
| −6 | K061345 | Modification to Endius Atavi System | Endius, Inc. | 2006 | 1 |
| −5 | K081051 | Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope | Spine View, Inc. | 2008 | — |
| −4 | K090278 | Enspire Debrider System | Spine View, Inc. | 2009 | — |
| −3 | K110992 | Enspire Debrider System | Spine View, Inc. | 2011 | — |
| −2 | K120553 | ESPIN | Nlt Spine, Ltd. | 2012 | — |
| −1 | K130057 | ESPIN | Nlt Spine, Ltd. | 2013 | — |
| 0 (this device) | K133061 | Espin System | Nlt Spine, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K120553 | ESPINSummary page 1…r Usual Name: Arthroscope and Accessories Classification Name: Arthroscope and Accessories 21 CFR §880.1100 Product Code HRX Predicate Devices * NLT SPINE eSPIN K120553, K1 30057 * Medtronic Inc. Midas Rex K081475 Intended Use / Indications for Use The eSPIN System is intended for use in… | 2012 |
| * | K130057 | ESPINSummary page 1…ame: Arthroscope and Accessories Classification Name: Arthroscope and Accessories 21 CFR §880.1100 Product Code HRX Predicate Devices * NLT SPINE eSPIN K120553, K1 30057 * Medtronic Inc. Midas Rex K081475 Intended Use / Indications for Use The eSPIN System is intended for use in cutting an… | 2013 |
| * | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Summary page 1…ation Name: Arthroscope and Accessories 21 CFR §880.1100 Product Code HRX Predicate Devices * NLT SPINE eSPIN K120553, K1 30057 * Medtronic Inc. Midas Rex K081475 Intended Use / Indications for Use The eSPIN System is intended for use in cutting and grinding intervertebral disc material du… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 6 of the 56 ancestors have a recall of any class.
- 1 other device also cites its predicate K120553.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 System 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 (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD 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/K133061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133061: Espin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133061
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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