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 · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Apr 2, 2012 as substantially equivalent to K110321 (Corelink, LLC, 2011) and 7 other predicates after a 26-day review. Its family tree reaches back 13 generations to 1985. 41 later devices descend from it.
- Decided
- Apr 2, 2012
- Review
- 26 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 13 generations to K853033 (1985). 123 ancestors in all, the oldest K841189 (1984). 41 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations between
- 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK111571 Viper SystemsJohnson & Johnson · 2011
- This deviceK120696 Tiger Spine SystemCorelink, LLC · 2012
- Descendant · cites it directly · 40 of its ownK131250 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
Show all 13 generations
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 11 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 10 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 9 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 8 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 7 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 6 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK111571 Viper SystemsJohnson & Johnson · 2011
- This deviceK120696 Tiger Spine SystemCorelink, LLC · 2012
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K131250Tiger Spine SystemCorelink, LLC · 2013 · cites it directly40descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −12 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −11 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −10 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −9 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −8 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −7 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −6 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −3 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −2 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −1 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| 0 (this device) | K120696 | Tiger Spine System | Corelink, LLC | 2012 | — |
| +1 | 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 | — |
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 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 10 | 0 |
| 1999 | 10 | 0 |
| 2000 | 8 | 0 |
| 2001 | 11 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 15 | 0 |
| 2005 | 8 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (8)
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 SystemSummary page 1…MNH CFR section: 21 CFR section 888.3070 Device panel: Orthopedic Legally Marketed TIGER TM Spine System (K1 10321) Predicate Device: Viper"'M Spine System (K061520/K<111571) Synergy VLS - open (1(000… | 2011 |
| * | K061520 | Viper Spine SystemSummary page 1…n 888.3070 Device panel: Orthopedic Legally Marketed TIGER TM Spine System (K1 10321) Predicate Device: Viper"'M Spine System (K061520/K<111571) Synergy VLS - open (1(000236) OePuy Spine - Moss Miami SS… | 2006 |
| * | K111571 | Viper SystemsSummary page 1…Device panel: Orthopedic Legally Marketed TIGER TM Spine System (K1 10321) Predicate Device: Viper"'M Spine System (K061520/K<111571) Synergy VLS - open (1(000236) OePuy Spine - Moss Miami SS (K950697… | 2011 |
| * | K000236 | Synergy VLS Cap Nut Models 2206, 6102Summary page 1…ly Marketed TIGER TM Spine System (K1 10321) Predicate Device: Viper"'M Spine System (K061520/K<111571) Synergy VLS - open (1(000236) OePuy Spine - Moss Miami SS (K950697) DePuy Spine - Moss Miami (K(… | 2000 |
| * | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle FixationSummary page 1…Device: Viper"'M Spine System (K061520/K<111571) Synergy VLS - open (1(000236) OePuy Spine - Moss Miami SS (K950697) DePuy Spine - Moss Miami (K(955348) Viper -DePuy (K(061520/Kl11157… | 1995 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 1…Synergy VLS - open (1(000236) OePuy Spine - Moss Miami SS (K950697) DePuy Spine - Moss Miami (K(955348) Viper -DePuy (K(061520/Kl111571) Click'X - Synthes (K(992739)… | 1996 |
| * | K992739 | Click'xSummary page 1…DePuy Spine - Moss Miami (K(955348) Viper -DePuy (K(061520/Kl111571) Click'X - Synthes (K(992739) Pangea - Synthes (K(052123) Submitter: Corelink, LLC… | 2000 |
| * | K052123 | Synthes Pangea SystemSummary page 1…Viper -DePuy (K(061520/Kl111571) Click'X - Synthes (K(992739) Pangea - Synthes (K(052123) Submitter: Corelink, LLC 10805 Sunset Office Drive, Suite 300… | 2005 |
What descends from it? (41)
See all 413 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 27 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 123 ancestors have a recall of any class.
- Of its descendants, K131250 (Corelink, LLC, 2013) has gone furthest, with 40 descendants of its own.
- 5 other devices also cite its predicate K110321.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TIGET 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, arnd sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).…
Read the full statement (122 words)
The TIGET 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, arnd sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as a pedicle screw system, the TIGER h Spine System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120696 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120696: Tiger Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120696
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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