510(k) · Cleared
ClearedTiGer Shark™ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine, LP · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 26, 2018 as substantially equivalent to K120991 (Trans1 Incorporated, 2012) and 2 other predicates after a 130-day review. Its family tree reaches back 20 generations to 1984. 1 of the 263 devices in its family, counting itself, has a Class I recall. 59 later devices descend from it.
- Decided
- Jan 26, 2018
- Review
- 130 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K841189 (1984). 203 ancestors in all. 59 later devices descend from it, 9 citing it directly. 1 of the 263 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 2 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- 1 generation backK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- This deviceK172816 TiGer Shark™ SystemChoicespine, LP · 2018
- Descendant · cites it directly · 25 of its ownK201671 A-Link ZAcuity Surgical Devices, LLC · 2021
- Descendant · cites it directly · 16 of its ownK183397 ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP · 2019
- Descendant · 2 generations on · 14 of its ownK222561 AlignAcuity Surgical Devices, LLC · 2022
- Descendant · 2 generations on · 9 of its ownK202398 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021
- Descendant · 3 generations on · 8 of its ownK232432 E3D™-A Interbody SystemEvolution Spine · 2024
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 10 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 9 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 8 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 7 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 6 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 5 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 4 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 3 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 2 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- 1 generation backK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- This deviceK172816 TiGer Shark™ SystemChoicespine, LP · 2018
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 59 · See all- K201671A-Link ZAcuity Surgical Devices, LLC · 2021 · cites it directly25descendants
- K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP · 2019 · cites it directly16descendants
- K222561AlignAcuity Surgical Devices, LLC · 2022 · 2 generations on14descendants
- K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021 · 2 generations on9descendants
- K232432E3D™-A Interbody SystemEvolution Spine · 2024 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −10 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −9 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −8 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −7 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −6 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −5 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −4 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −3 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −2 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
| −1 | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| 0 (this device) | K172816 | TiGer Shark™ System | Choicespine, LP | 2018 | — |
| +1 | K201671 | A-Link Z | Acuity Surgical Devices, LLC | 2021 | — |
| +1 | K183397 | ChoiceSpine Stealth Cervical Spacer System | Choicespine, LP | 2019 | — |
| +2 | K222561 | Align | Acuity Surgical Devices, LLC | 2022 | — |
| +2 | K202398 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2021 | — |
| +3 | K232432 | E3D™-A Interbody System | Evolution Spine | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 19 | 0 |
| 2006 | 7 | 0 |
| 2007 | 10 | 0 |
| 2008 | 29 | 1 |
| 2009 | 16 | 0 |
| 2010 | 12 | 0 |
| 2011 | 11 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 14 | 0 |
| 2025 | 12 | 0 |
| 2026 | 12 | 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.
1 device in this family has a Class I recall. 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K120991 | TRANS1 Interbody Fusion SystemSummary page 5…idence – per ASTM F2267 Substantial Equivalence: The implants included in this submission are equivalent to the TranS1 Interbody Fusion System (K120991, primary predicate), and Spineart Intervertebral Fusion Device Juliet PO (K142277), Choice Spine Lumbar… | 2012 |
| * | K142277 | Juliet POSummary page 5…o the TranS1 Interbody Fusion System (K120991, primary predicate), and Spineart Intervertebral Fusion Device Juliet PO (K142277), Choice Spine Lumbar Spacer System, (K162103), as additional predicates. Substantial Equivalence Conc… | 2014 |
| * | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Summary page 5…primary predicate), and Spineart Intervertebral Fusion Device Juliet PO (K142277), Choice Spine Lumbar Spacer System, (K162103), as additional predicates. Substantial Equivalence Conclusion: The implants proposed in this submission are identi… | 2016 |
What descends from it? (59)
See all 599 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201671 | A-Link Z | 2021 | 25 |
| K183397 | ChoiceSpine Stealth Cervical Spacer System | 2019 | 16 |
| K210090 | Impulse AM Interbody Fusion System | 2021 | 7 |
| K252610 | ZSFab Lumbar Interbody System | 2025 | 1 |
| K242771 | Tesera-k PL System and Tesera-k XL System | 2025 | 1 |
| K213417 | Ghost Spacer System | 2022 | 0 |
| K220953 | ChoiceSpine TigerShark™ M, Modular Interbody System | 2022 | 0 |
| K201939 | GAIA Lumbar Interbody Fusion Device (LIFD) Family | 2020 | 0 |
| K180519 | HARRIER-SA™ Lumbar Interbody System | 2018 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 16 companies; a new generation was cleared every 9 months on median.
- 27 of the 203 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K201671 (Acuity Surgical Devices, LLC, 2021) has gone furthest, with 25 descendants of its own.
- 2 other devices also cite its predicate K120991.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Choice Spine TiGer Shark™ System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six…
Read the full statement (116 words)
The Choice Spine TiGer Shark™ System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six (6) months of non-operative treatment. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. This device is designed for use with supplemental fixation that is cleared for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172816: TiGer Shark™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172816
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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