510(k) Report

510(k) · Cleared

Cleared

Tiger Spine System

K133369510(k) SpecialCleared Jan 14, 201474-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Corelink, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jan 14, 2014 as substantially equivalent to K110321 (Corelink, LLC, 2011) and 12 other predicates after a 74-day review. Its family tree reaches back 15 generations to 1985. 29 later devices descend from it.

Decided
Jan 14, 2014
Review
74 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
15

Its longest line of descent runs back 15 generations to K853033 (1985). 218 ancestors in all, the oldest K841189 (1984). 29 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 2 other ancestors2011: 3 other ancestors2010: 11 other ancestors2009: 8 other ancestors2007: 9 other ancestors2005: 16 other ancestors2004: 21 other ancestors2008: 7 other ancestors2006: 10 other ancestors2003: 10 other ancestors2002: 11 other ancestors2001: 18 other ancestors2000: 18 other ancestors1999: 15 other ancestors1998: 11 other ancestors1997: 7 other ancestors1996: 6 other ancestors1995: 6 other ancestors1994: 3 other ancestors1993: 3 other ancestors1992: 5 other ancestors1990: 2 other ancestors1984: 1 other ancestor2019: 3 descendants cleared2020: 2 descendants cleared2025: 7 descendants cleared2016: 2 descendants cleared2023: 6 descendants cleared2015: 1 descendant cleared2022: 2 descendants cleared2024: 5 descendants cleared2026: 1 descendant clearedK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004×3: 3 generations cleared close together, K062174 (2006), K063156 (2006), K063741 (2007) K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K111571 · Viper Systems · Johnson & Johnson · 2011K120696 · Tiger Spine System · Corelink, LLC · 2012K131250 · Tiger Spine System · Corelink, LLC · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 37 other ancestors3 generations back: 33 other ancestors4 generations back: 54 other ancestors5 generations back: 31 other ancestors6 generations back: 30 other ancestors7 generations back: 6 other ancestors8 generations back: 5 other ancestors 1 generation forward: 7 descendants2 generations forward: 9 descendants3 generations forward: 1 descendant4 generations forward: 4 descendants5 generations forward: 4 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant K131250 · Tiger Spine System · Corelink, LLC · 2013K120696 · Tiger Spine System · Corelink, LLC · 2012K111571 · Viper Systems · Johnson & Johnson · 2011K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K063741 · Expedium Spine System · Depuy Spine, Inc. · 2007K063156 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−15−10−50+5
  1. Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 11 generations between
  3. 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
  4. 2 generations backK120696 Tiger Spine SystemCorelink, LLC · 2012
  5. 1 generation backK131250 Tiger Spine SystemCorelink, LLC · 2013
  6. This deviceK133369 Tiger Spine SystemCorelink, LLC · 2014
  7. Descendant · cites it directly · 17 of its ownK153453 Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
  8. Descendant · 2 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
  9. Descendant · 3 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
  10. Descendant · 4 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
  11. Descendant · 4 generations on · 4 of its ownK240326 Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024
Show all 15 generations
  1. Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 7 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  10. 6 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  11. 5 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
  12. 4 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  13. 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
  14. 2 generations backK120696 Tiger Spine SystemCorelink, LLC · 2012
  15. 1 generation backK131250 Tiger Spine SystemCorelink, LLC · 2013
  16. This deviceK133369 Tiger Spine SystemCorelink, LLC · 2014

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2015: 12016: 22019: 32020: 22022: 22023: 62024: 52025: 72026: 1
2015high 7 (2025) · low 0 (2017)2026

Most influential descendants

Showing 5 of 29 · See all
  • K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016 · cites it directly17descendants
  • K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 2 generations on13descendants
  • K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 3 generations on12descendants
  • K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 4 generations on5descendants
  • K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−14K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−13K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−12K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−11K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−10K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−9K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−8K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−7K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−6K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−5K063741Expedium Spine SystemDepuy Spine, Inc.2007—
−4K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008—
−3K111571Viper SystemsJohnson & Johnson2011—
−2K120696Tiger Spine SystemCorelink, LLC2012—
−1K131250Tiger Spine SystemCorelink, LLC2013—
0 (this device)K133369Tiger Spine SystemCorelink, LLC2014—
+1K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC2016—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems2019—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems2022—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical2023—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199020
199250
199330
199430
199560
199660
199770
1998110
1999150
2000180
2001180
2002110
2003100
2004210
2005160
2006100
200790
200870
200980
2010110
201130
201220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201620
201930
202020
202220
202360
202450
202570
202610
FIG. 1 — Lineage of K133369, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (15)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K110321Tiger Spine System
Summary page 1
…FR section 888.3070 21 GFR section 888.3050 Device panel: Orthopedic Legally Marketed TIGER@®Spine System (110321,1<1 13058,1120696,1K121728.,1131250) Predicate Device: Expedium" Niper Spine System (K<033901,1K051024,1K062174,1K06…
Corelink, LLC2011—
Kept off the family treeK111305FDA’s K111305 is Universal Digital Interface Wireless - Udi 1417W
Our reading of the summary gave K111305, FDA’s number for Universal Digital Interface Wireless - Udi 1417W (Meridian Medical Systems, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “TIGER Spine System”. Kept off the family tree.
Meridian Medical Systems, LLC2012—
*K120696Tiger Spine System
Summary page 1
…0 21 GFR section 888.3050 Device panel: Orthopedic Legally Marketed TIGER@®Spine System (110321,1<1 13058,1120696,1K121728.,1131250) Predicate Device: Expedium" Niper Spine System (K<033901,1K051024,1K062174,1K063156,…
Corelink, LLC2012—
*K121728Tiger Spine System
Summary page 1
…21 GFR section 888.3050 Device panel: Orthopedic Legally Marketed TIGER@®Spine System (110321,1<1 13058,1120696,1K121728.,1131250) Predicate Device: Expedium" Niper Spine System (K<033901,1K051024,1K062174,1K063156,…
Corelink, LLC2012—
*K131250Tiger Spine System
Summary page 1
…21 GFR section 888.3050 Device panel: Orthopedic Legally Marketed TIGER@®Spine System (110321,1<1 13058,1120696,1K121728.,1131250) Predicate Device: Expedium" Niper Spine System (K<033901,1K051024,1K062174,1K063156,…
Corelink, LLC2013—
*K033901Merlin Spine System
Summary page 1
…Orthopedic Legally Marketed TIGER@®Spine System (110321,1<1 13058,1120696,1K121728.,1131250) Predicate Device: Expedium" Niper Spine System (K<033901,1K051024,1K062174,1K063156, 1<063741,1<080313,K1<81898,1<090648,1<101993)…
Depuy Spine, Inc.2004—
*K051024Expedium Spine System
Summary page 1
…dic Legally Marketed TIGER@®Spine System (110321,1<1 13058,1120696,1K121728.,1131250) Predicate Device: Expedium" Niper Spine System (K<033901,1K051024,1K062174,1K063156, 1<063741,1<080313,K1<81898,1<090648,1<101993)…
Depuy Spine, Inc.2005—
*K062174Modification to Expedium Spine System
Summary page 1
…Legally Marketed TIGER@®Spine System (110321,1<1 13058,1120696,1K121728.,1131250) Predicate Device: Expedium" Niper Spine System (K<033901,1K051024,1K062174,1K063156, 1<063741,1<080313,K1<81898,1<090648,1<101993) Scieni'x…
Depuy Spine, Inc.2006—
*K063156Modification to Expedium Spine System
Summary page 1
…egally Marketed TIGER@®Spine System (110321,1<1 13058,1120696,1K121728.,1131250) Predicate Device: Expedium" Niper Spine System (K<033901,1K051024,1K062174,1K063156, 1<063741,1<080313,K1<81898,1<090648,1<101993) Scieni'x Polyaxial…
Depuy Spine, Inc.2006—
*K063741Expedium Spine System
Summary page 1
…,1<1 13058,1120696,1K121728.,1131250) Predicate Device: Expedium" Niper Spine System (K<033901,1K051024,1K062174,1K063156, 1<063741,1<080313,K1<81898,1<090648,1<101993) Scieni'x Polyaxial LP' (K<062912) Submi…
Depuy Spine, Inc.2007—
*K080313Modification to Expedium Spine System
Summary page 1
…8,1120696,1K121728.,1131250) Predicate Device: Expedium" Niper Spine System (K<033901,1K051024,1K062174,1K063156, 1<063741,1<080313,K1<81898,1<090648,1<101993) Scieni'x Polyaxial LP' (K<062912) Submitter: Cor…
Depuy Spine, Inc.2008—
Kept off the family treeK081898FDA’s K081898 is Expedium Spine System
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Depuy Spine, Inc.2008—
*K090648Viper 2 System
Summary page 1
….,1131250) Predicate Device: Expedium" Niper Spine System (K<033901,1K051024,1K062174,1K063156, 1<063741,1<080313,K1<81898,1<090648,1<101993) Scieni'x Polyaxial LP' (K<062912) Submitter: Corelink, LLC…
Depuy Spine, Inc.2009—
*K101993Viper System, Expedium System
Summary page 1
…) Predicate Device: Expedium" Niper Spine System (K<033901,1K051024,1K062174,1K063156, 1<063741,1<080313,K1<81898,1<090648,1<101993) Scieni'x Polyaxial LP' (K<062912) Submitter: Corelink, LLC…
Depuy Spine, Inc.20108
*K062912Scient'x Spinal System
Summary page 1
…33901,1K051024,1K062174,1K063156, 1<063741,1<080313,K1<81898,1<090648,1<101993) Scieni'x Polyaxial LP' (K<062912) Submitter: Corelink, LLC 7606 Forsyth Blvd…
Scient'X2007—

Also cleared against K110321: 5 other devices →

What descends from it? (29)

See all 29

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617
K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192
K193211Nano FortiFix® SystemNanovis Spine, LLC20201
K193219G Surgical Marksman SystemG Surgical, LLC20191
K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151
K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250
K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230

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 29 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
  • 14 of the 218 ancestors have a recall of any class.
  • Of its descendants, K153453 (Nexxt Spine, LLC, 2016) has gone furthest, with 17 descendants of its own.
  • 5 other devices also cite its predicate K110321.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The TIGERS 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 Si/h~ewn): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic stuidies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusaion (pseudartbrosis).

Indications for use as stated in the FDA summary.

Also cleared against K110321

5 other devices cite the same predicate.

  • K210539CoreLink Midline Fixation SystemCorelink, LLC · 2021
  • K131250Tiger Spine SystemCorelink, LLC · 2013
  • K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd. · 2012
  • K120696Tiger Spine SystemCorelink, LLC · 2012
  • K113058Tiger Spine SystemCorelink, LLC · 2012

More from Corelink, LLC

35 FDA decisions under this applicant name. See the company

  • K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystemCorelink, LLC · 2023
  • K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC · 2023
  • K232116CoreLink Navigation InstrumentsCorelink, LLC · 2023
  • K230329F3D Interbody SystemCorelink, LLC · 2023
  • K230880CoreLink Navigation InstrumentsCorelink, LLC · 2023

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K133369 · printed Nov 4, 2026

Cite this page

510(k) Report. “K133369: Tiger Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133369

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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