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 Sep 10, 2013 as substantially equivalent to K110321 (Corelink, LLC, 2011) and 13 other predicates after a 131-day review. Its family tree reaches back 14 generations to 1985. 40 later devices descend from it.
- Decided
- Sep 10, 2013
- Review
- 131 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 14 generations to K853033 (1985). 203 ancestors in all, the oldest K841189 (1984). 40 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 1 generation backK120696 Tiger Spine SystemCorelink, LLC · 2012
- This deviceK131250 Tiger Spine SystemCorelink, LLC · 2013
- Descendant · cites it directly · 29 of its ownK133369 Tiger Spine SystemCorelink, LLC · 2014
- Descendant · 2 generations on · 17 of its ownK153453 Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
- Descendant · 3 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
- Descendant · 4 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
- Descendant · 5 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 1 generation backK120696 Tiger Spine SystemCorelink, LLC · 2012
- This deviceK131250 Tiger Spine SystemCorelink, LLC · 2013
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K133369Tiger Spine SystemCorelink, LLC · 2014 · cites it directly29descendants
- K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016 · 2 generations on17descendants
- K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 3 generations on13descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 4 generations on12descendants
- K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −1 | K120696 | Tiger Spine System | Corelink, LLC | 2012 | — |
| 0 (this device) | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| +1 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| +2 | K153453 | Inertia Pedicle Screw and Deformity Correxxion System | Nexxt Spine, LLC | 2016 | — |
| +3 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
| +4 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
| +5 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 7 | 0 |
| 1998 | 11 | 0 |
| 1999 | 14 | 0 |
| 2000 | 15 | 0 |
| 2001 | 18 | 0 |
| 2002 | 8 | 0 |
| 2003 | 9 | 0 |
| 2004 | 19 | 0 |
| 2005 | 15 | 0 |
| 2006 | 9 | 0 |
| 2007 | 8 | 0 |
| 2008 | 7 | 0 |
| 2009 | 8 | 0 |
| 2010 | 10 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2025 | 9 | 0 |
| 2026 | 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 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? (14)
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 |
|---|---|---|---|
| * | K110321 | Tiger Spine System | 2011 |
| * | K120696 | Tiger Spine SystemSummary page 2…on to the components of the TIGER® Spine System do not substantially differ fromt thle legally marketed predicate devices, which are the TIGER® Spine System (KI 11032 1. K 120696, K 113058, and K1 2I728), Depuy Expedium Offset (K 10 1070). Depuy Monarch (K024"348 and K0 10576), EBI Omnega 21 (K014 137, K(00… | 2012 |
| * | K113058 | Tiger Spine SystemSummary page 1…HANGE FROM PREDICATE: The purpose of this submission is to make modificat ions/add it ions to the components of the TIGER®R Spine System cleared in KI 11032 1, Kl120696, K 113058, and K 121728. The standard Tiger®R Spine System Line Extension… | 2012 |
| * | K121728 | Tiger Spine SystemSummary page 1…Orhoeic and Rehabilitation Devices Panel Predicate Devices: TIGER® Spine System (KI 10321, K1210696. KI 13058. and K121728) Depuly Expediumn Offset (K10l1070) Depuy Monarch (K0243 48 a… | 2012 |
| * | K101070 | Expedium Spine SystemSummary page 2…stantially differ fromt thle legally marketed predicate devices, which are the TIGER® Spine System (KI 11032 1. K 120696, K 113058, and K1 2I728), Depuy Expedium Offset (K 10 1070). Depuy Monarch (K024"348 and K0 10576), EBI Omnega 21 (K014 137, K(00 1357. K(992333, K991721, K(990303. and K(973683). and Medt… | 2010 |
| * | K024348 | Monarch Spine SystemSummary page 1…058. and K121728) Depuly Expediumn Offset (K10l1070) Depuy Monarch (K0243 48 and KO010576) EBI Omega 21 (K014 137, KOC 1357, K992333), K991721.… | 2003 |
| * | K010576 | Monarch Spine SystemSummary page 2…keted predicate devices, which are the TIGER® Spine System (KI 11032 1. K 120696, K 113058, and K1 2I728), Depuy Expedium Offset (K 10 1070). Depuy Monarch (K024"348 and K0 10576), EBI Omnega 21 (K014 137, K(00 1357. K(992333, K991721, K(990303. and K(973683). and Medtronic Sofamior Danek TSRHI-3D (K(02 117… | 2001 |
| * | K014137 | Modification to Ebi Omega 21 SystemSummary page 1…Depuly Expediumn Offset (K10l1070) Depuy Monarch (K0243 48 and KO010576) EBI Omega 21 (K014 137, KOC 1357, K992333), K991721. K990303, and K973683) Medtronic… | 2002 |
| * | K001357 | Modification to Omega 21 System | 2000 |
| * | K992333 | Ebi Omega 21 SystemSummary page 1…y Expediumn Offset (K10l1070) Depuy Monarch (K0243 48 and KO010576) EBI Omega 21 (K014 137, KOC 1357, K992333), K991721. K990303, and K973683) Medtronic Sofanor Danek TSRH… | 1999 |
| * | K991721 | Ebi Omega 21 SystemSummary page 1…n Offset (K10l1070) Depuy Monarch (K0243 48 and KO010576) EBI Omega 21 (K014 137, KOC 1357, K992333), K991721. K990303, and K973683) Medtronic Sofanor Danek TSRH-3D (K021… | 1999 |
| * | K990303 | Ebi Omega 21 SystemSummary page 1…Depuy Monarch (K0243 48 and KO010576) EBI Omega 21 (K014 137, KOC 1357, K992333), K991721. K990303, and K973683) Medtronic Sofanor Danek TSRH-3D (K021 170) DESCRIPTION OF THE DEVICE SUBJECT TO… | 1999 |
| * | K973683 | Omega 21 SystemSummary page 1…puy Monarch (K0243 48 and KO010576) EBI Omega 21 (K014 137, KOC 1357, K992333), K991721. K990303, and K973683) Medtronic Sofanor Danek TSRH-3D (K021 170) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOT… | 1997 |
| * | K021170 | TSRH Spinal SystemSummary page 1…ega 21 (K014 137, KOC 1357, K992333), K991721. K990303, and K973683) Medtronic Sofanor Danek TSRH-3D (K021 170) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The TIGER® Spine System is a multiple component, posterior spinal… | 2002 |
What descends from it? (40)
See all 403 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 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 203 ancestors have a recall of any class.
- Of its descendants, K133369 (Corelink, LLC, 2014) has gone furthest, with 29 descendants of its own.
- 5 other devices also cite its predicate K110321.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 TIGER® 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 spine (T1-S1/ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history of and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131250: 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/K131250
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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