510(k) · Cleared
ClearedTiger 2 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation Medical Products, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 24, 2026 as substantially equivalent to K243908 (Zavation Medical Products, LLC, 2025) and 2 other predicates after a 226-day review. Its family tree reaches back 22 generations to 2004.
- Decided
- Jul 24, 2026
- Review
- 226 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K040583 (2004). 351 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations between
- 3 generations backK231479 TriALTIS Spine SystemMedos International SARL · 2023
- 2 generations backK233684 TriALTIS™ Spine SystemMedos International SARL · 2023
- 1 generation backK253249 TriALTIS™ Spine SystemMedos International SARL · 2025
- This deviceK253943 Tiger 2 SystemZavation Medical Products, LLC · 2026
Show all 22 generations
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 21 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 19 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 18 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 17 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 15 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 14 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 13 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 12 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 11 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 10 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 9 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 8 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 7 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 6 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 5 generations backK200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl · 2020
- 4 generations backK220374 EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL · 2022
- 3 generations backK231479 TriALTIS Spine SystemMedos International SARL · 2023
- 2 generations backK233684 TriALTIS™ Spine SystemMedos International SARL · 2023
- 1 generation backK253249 TriALTIS™ Spine SystemMedos International SARL · 2025
- This deviceK253943 Tiger 2 SystemZavation Medical Products, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −21 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −19 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −18 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −17 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −15 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −14 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −13 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −12 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −11 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −10 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −9 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −8 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −7 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| −6 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| −5 | K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System | Medos International Sàrl | 2020 | — |
| −4 | K220374 | EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) | Medos International SARL | 2022 | — |
| −3 | K231479 | TriALTIS Spine System | Medos International SARL | 2023 | — |
| −2 | K233684 | TriALTIS™ Spine System | Medos International SARL | 2023 | — |
| −1 | K253249 | TriALTIS™ Spine System | Medos International SARL | 2025 | — |
| 0 (this device) | K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 10 | 0 |
| 1996 | 9 | 0 |
| 1997 | 8 | 0 |
| 1998 | 17 | 0 |
| 1999 | 12 | 0 |
| 2000 | 21 | 0 |
| 2001 | 26 | 0 |
| 2002 | 21 | 0 |
| 2003 | 20 | 0 |
| 2004 | 30 | 0 |
| 2005 | 27 | 0 |
| 2006 | 21 | 0 |
| 2007 | 11 | 0 |
| 2008 | 16 | 0 |
| 2009 | 13 | 0 |
| 2010 | 12 | 0 |
| 2011 | 10 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K243908 | Tiger 2 SystemSummary page 6…s 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: K243908 Tiger 2 System (Zavation) Additional Predicate Devices: K253249 TriALTIS Spine System (Medos International) K172269 CREO Fenestr… | 2025 |
| * | K253249 | TriALTIS™ Spine SystemSummary page 6…y ASTM F136 and cobalt chrome alloy (Co‐28Cr‐6Mo) as described by ASTM F1537. Primary Predicate Device: K243908 Tiger 2 System (Zavation) Additional Predicate Devices: K253249 TriALTIS Spine System (Medos International) K172269 CREO Fenestrated Screw System (Globus) Performance Data: Mechanical testing… | 2025 |
| * | K172269 | FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Summary page 6…described by ASTM F1537. Primary Predicate Device: K243908 Tiger 2 System (Zavation) Additional Predicate Devices: K253249 TriALTIS Spine System (Medos International) K172269 CREO Fenestrated Screw System (Globus) Performance Data: Mechanical testing was completed on the Tiger 2 System worst case const… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 8 companies; a new generation was cleared every 7 months on median.
- 43 of the 351 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 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 (204 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).
When used in conjunction with Teknimed F20 Bone Cement the fenestrated screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The fenestrated Tiger 2 System screws augmented with Teknimed F20 Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253943: Tiger 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253943
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026