510(k) · Cleared
ClearedTiger Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corelink, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 29, 2012 as substantially equivalent to K110906 (Spinecraft, LLC, 2011) and 1 other predicate after a 167-day review. Its family tree reaches back 11 generations to 1999. 81 later devices descend from it.
- Decided
- Mar 29, 2012
- Review
- 167 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K990745 (1999). 128 ancestors in all, the oldest K901587 (1990). 81 later devices descend from it, 9 citing it directly.
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations between
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 1 generation backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- This deviceK113058 Tiger Spine SystemCorelink, LLC · 2012
- Descendant · cites it directly · 40 of its ownK131250 Tiger Spine SystemCorelink, LLC · 2013
- Descendant · cites it directly · 30 of its ownK151977 icotec Pedicle SystemIcotec AG · 2016
- Descendant · cites it directly · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
- Descendant · 2 generations on · 29 of its ownK133369 Tiger Spine SystemCorelink, LLC · 2014
- Descendant · cites it directly · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
Show all 11 generations
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 9 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 8 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 7 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 6 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 5 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 4 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 1 generation backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- This deviceK113058 Tiger Spine SystemCorelink, LLC · 2012
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · See all- K131250Tiger Spine SystemCorelink, LLC · 2013 · cites it directly40descendants
- K151977icotec Pedicle SystemIcotec AG · 2016 · cites it directly30descendants
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · cites it directly29descendants
- K133369Tiger Spine SystemCorelink, LLC · 2014 · 2 generations on29descendants
- K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · cites it directly27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −10 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −9 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −8 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −7 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −6 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −5 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −4 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −3 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −2 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −1 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| 0 (this device) | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| +1 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| +1 | K151977 | icotec Pedicle System | Icotec AG | 2016 | — |
| +1 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
| +2 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| +1 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 8 | 0 |
| 2002 | 2 | 0 |
| 2003 | 7 | 0 |
| 2004 | 14 | 0 |
| 2005 | 8 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 13 | 0 |
| 2024 | 15 | 0 |
| 2025 | 12 | 0 |
| 2026 | 7 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K110906 | Apex Spine SystemSummary page 2…Degenerative Disc Disease (DDD). Predicate Devices: The TIGER TMSpine System was shown to be substantially equivalent to previously cleared devices (K1 10906 and K110321). Substantial Equivalence: Testing performed on this device indicates that the TIGERm Spine System is substantially… | 2011 |
| * | K110321 | Tiger Spine SystemSummary page 2…tive Disc Disease (DDD). Predicate Devices: The TIGER TMSpine System was shown to be substantially equivalent to previously cleared devices (K1 10906 and K110321). Substantial Equivalence: Testing performed on this device indicates that the TIGERm Spine System is substantially equivalent t… | 2011 |
What descends from it? (81)
See all 819 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131250 | Tiger Spine System | 2013 | 40 |
| K151977 | icotec Pedicle System | 2016 | 30 |
| K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | 2019 | 29 |
| K200596 | G21 Cement, VADER® Pedicle System | 2020 | 27 |
| K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 | 2020 | 6 |
| K131785 | Pagoda Pedicle Screw System | 2013 | 6 |
| K142146 | Ibis Pedicle Screw System | 2014 | 5 |
| K121786 | Dymaxeon Spine System | 2012 | 5 |
| K150184 | Dymaxeon Spine System | 2015 | 4 |
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 4 companies; a new generation was cleared every 10 months on median.
- 7 of the 128 ancestors have a recall of any class.
- Of its descendants, K131250 (Corelink, LLC, 2013) has gone furthest, with 40 descendants of its own.
- 2 other devices also cite its predicate K110906.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The TIGERTM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (TI - S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113058: Tiger Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113058
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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