510(k) Report

510(k) · Cleared

Cleared

Tiger 2 System

K243908510(k) TraditionalCleared Feb 3, 202546-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

Zavation Medical Products, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Feb 3, 2025 as substantially equivalent to K222614 (Zavation Medical Products, LLC, 2022) after a 46-day review. Its family tree reaches back 20 generations to 2004. 1 later device descends from it.

Decided
Feb 3, 2025
Review
46 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
1

Its longest line of descent runs back 20 generations to K040583 (2004). 243 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2019: 1 other ancestor2016: 2 other ancestors2008: 12 other ancestors2015: 1 other ancestor2003: 16 other ancestors2002: 17 other ancestors2001: 20 other ancestors2000: 16 other ancestors2012: 4 other ancestors2011: 7 other ancestors2010: 8 other ancestors2004: 24 other ancestors1999: 5 other ancestors1998: 14 other ancestors2009: 4 other ancestors2007: 5 other ancestors2006: 13 other ancestors2005: 18 other ancestors1997: 6 other ancestors1996: 9 other ancestors1995: 7 other ancestors1978: 1 other ancestor1994: 3 other ancestors1984: 1 other ancestor1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors2026: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121630 · Range Spinal System · K2m, Inc. · 2012K130932 · Firebird Spinal Fixation System · Orthofix, Inc. · 2013 · recalledK151488 · Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System · Orthofix, Inc. · 2015 · recalledK153428 · Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System · Orthofix, Inc. · 2016 · recalledK171082 · Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System · Orthofix, Inc. · 2017 · recalledK180179 · Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw · Orthofix, Inc. · 2018K211113 · Zavation Spinal System · Zavation Medical Products, LLC · 2021K222614 · Zavation Spinal System · Zavation Medical Products, LLC · 202219801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 2 other ancestors4 generations back: 2 other ancestors5 generations back: 11 other ancestors6 generations back: 24 other ancestors7 generations back: 32 other ancestors8 generations back: 64 other ancestors9 generations back: 47 other ancestors10 generations back: 21 other ancestors11 generations back: 18 other ancestors12 generations back: 2 other ancestors 1 generation forward: 1 descendant K222614 · Zavation Spinal System · Zavation Medical Products, LLC · 2022K211113 · Zavation Spinal System · Zavation Medical Products, LLC · 2021K180179 · Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw · Orthofix, Inc. · 2018K171082 · Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System · Orthofix, Inc. · 2017 · recalledK153428 · Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System · Orthofix, Inc. · 2016 · recalledK151488 · Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System · Orthofix, Inc. · 2015 · recalledK130932 · Firebird Spinal Fixation System · Orthofix, Inc. · 2013 · recalledK121630 · Range Spinal System · K2m, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−20−15−10−50
  1. Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 16 generations between
  3. 3 generations backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
  4. 2 generations backK211113 Zavation Spinal SystemZavation Medical Products, LLC · 2021
  5. 1 generation backK222614 Zavation Spinal SystemZavation Medical Products, LLC · 2022
  6. This deviceK243908 Tiger 2 SystemZavation Medical Products, LLC · 2025
  7. Descendant · cites it directly · 0 of its ownK253943 Tiger 2 SystemZavation Medical Products, LLC · 2026
Show all 20 generations
  1. Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 8 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
  14. 7 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
  15. 6 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
  16. 5 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
  17. 4 generations backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
  18. 3 generations backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
  19. 2 generations backK211113 Zavation Spinal SystemZavation Medical Products, LLC · 2021
  20. 1 generation backK222614 Zavation Spinal SystemZavation Medical Products, LLC · 2022
  21. This deviceK243908 Tiger 2 SystemZavation Medical Products, LLC · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K253943Tiger 2 SystemZavation Medical Products, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−19K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−17K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−16K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−15K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−14K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−13K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−12K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−11K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−10K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−9K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−8K121630Range Spinal SystemK2m, Inc.2012—
−7K130932Firebird Spinal Fixation SystemOrthofix, Inc.20131
−6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.20151
−5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.20161
−4K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS…Orthofix, Inc.20171
−3K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System…Orthofix, Inc.2018—
−2K211113Zavation Spinal SystemZavation Medical Products, LLC2021—
−1K222614Zavation Spinal SystemZavation Medical Products, LLC2022—
0 (this device)K243908Tiger 2 SystemZavation Medical Products, LLC2025—
+1K253943Tiger 2 SystemZavation Medical Products, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199020
199250
199320
199430
199570
199690
199760
1998140
199950
2000160
2001200
2002170
2003160
2004240
2005180
2006130
200750
2008120
200940
201080
201170
201240
201510
201620
201910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K243908, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K222614Zavation Spinal System
Summary page 6
…are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136, and cobalt chrome alloy (Co-28Cr-6Mo) as described by ASTM F1537. Primary Predicate Device: K222614 Zavation Spinal System [Zavation] Performance Data: Static compression bending and torsion, and dynamic compression bending were…
Zavation Medical Products, LLC2022—

Also cleared against K222614: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K253943Tiger 2 SystemZavation Medical Products, LLC20260

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 21 years and passes through 6 companies; a new generation was cleared every 11 months on median.
  • 34 of the 243 ancestors have a recall of any class.
  • Of its descendants, K253943 (Zavation Medical Products, LLC, 2026) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K222614.

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. 2025, 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 Tiger 2 System is a pedicle screw system 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous…

Read the full statement (133 words)

The Tiger 2 System is a pedicle screw system 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Tiger 2 System when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Tiger 2 System Fenestrated Screws are intended to be used with saline and radiopaque dye.

Indications for use as stated in the FDA summary.

Also cleared against K222614

1 other device cites the same predicate.

  • K231811Zavation Connector SystemZavation Medical Products, LLC · 2023

More from Zavation Medical Products, LLC

31 FDA decisions under this applicant name. See the company

  • K253943Tiger 2 SystemZavation Medical Products, LLC · 2026
  • K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation…Zavation Medical Products, LLC · 2024
  • K231811Zavation Connector SystemZavation Medical Products, LLC · 2023
  • K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC · 2023
  • K230731Zavation ALIF SystemZavation Medical Products, 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/K243908 · printed Nov 5, 2026

Cite this page

510(k) Report. “K243908: Tiger 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243908

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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