510(k) · Cleared
ClearedTryptik Ti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Apr 6, 2020 as substantially equivalent to K171496 (Stryker Spine, 2017) and 5 other predicates after a 60-day review. Its family tree reaches back 22 generations to 1984. 1 of the 305 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Apr 6, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 22 generations to K841189 (1984). 302 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 305 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK160955 Tritanium® PL CageStryker · 2016
- 2 generations backK162262 Tritanium® PL CageStryker · 2016
- 1 generation backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- This deviceK200312 Tryptik TiSpineart · 2020
- Descendant · cites it directly · 1 of its ownK230583 Tryptik TiSpineart SA · 2023
- Descendant · cites it directly · 0 of its ownK240699 SCARLET® AC-TiSpineart SA · 2024
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 4 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 3 generations backK160955 Tritanium® PL CageStryker · 2016
- 2 generations backK162262 Tritanium® PL CageStryker · 2016
- 1 generation backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- This deviceK200312 Tryptik TiSpineart · 2020
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −4 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −3 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −2 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −1 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| 0 (this device) | K200312 | Tryptik Ti | Spineart | 2020 | — |
| +1 | K230583 | Tryptik Ti | Spineart SA | 2023 | — |
| +1 | K240699 | SCARLET® AC-Ti | Spineart SA | 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 | 23 | 0 |
| 2005 | 18 | 0 |
| 2006 | 7 | 0 |
| 2007 | 13 | 0 |
| 2008 | 42 | 1 |
| 2009 | 30 | 0 |
| 2010 | 17 | 0 |
| 2011 | 27 | 0 |
| 2012 | 13 | 0 |
| 2013 | 16 | 0 |
| 2014 | 18 | 0 |
| 2015 | 11 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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.
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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K171496 | Tritanium C Anterior Cervical CageSummary page 4…roduct Code ODP CFR section 888.3080 Device panel ORTHOPEDIC Primary predicate: Tritanium C Anterior Cervical Cage (K171496) manufactured by STRYKER SPINE Additional predicates: Tryptik® CA /CC (K091873 / K1… | 2017 |
| * | K091873 | Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-SSummary page 4…edicate: Tritanium C Anterior Cervical Cage (K171496) manufactured by STRYKER SPINE Additional predicates: Tryptik® CA /CC (K091873 / K122366) manufactured by Legally marketed SPINEART; EIT Cellular Titanium Cervical Cage, EIT Cellular Ti… | 2009 |
| * | K122366 | Tryptik CC Anterior Intersomatic Cervical CageSummary page 4…ritanium C Anterior Cervical Cage (K171496) manufactured by STRYKER SPINE Additional predicates: Tryptik® CA /CC (K091873 / K122366) manufactured by Legally marketed SPINEART; EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLI… | 2012 |
| * | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Summary page 4…Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT predicate devices Cellular Titanium TLIF Cages, And EIT Cellular Titanium ALIF Cage (K170503 / K172888) manufactured by EIT Emerging Implant Technologies GmbH and Juliet® Ti (K153621)… | 2017 |
| * | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Summary page 4…ervical Cage, EIT Cellular Titanium PLIF Cages, EIT predicate devices Cellular Titanium TLIF Cages, And EIT Cellular Titanium ALIF Cage (K170503 / K172888) manufactured by EIT Emerging Implant Technologies GmbH and Juliet® Ti (K153621) ma… | 2017 |
| * | K153621 | Juliet® TiSummary page 4…itanium TLIF Cages, And EIT Cellular Titanium ALIF Cage (K170503 / K172888) manufactured by EIT Emerging Implant Technologies GmbH and Juliet® Ti (K153621) manufactured by Spineart. TRYPTIK®Ti cages are indicated for use in skeletally mat… | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 39 of the 302 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K230583 (Spineart SA, 2023) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K171496.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK®Ti cages is used to facilitate intervertebral body fusion in the cervical spine using autogenous and/or…
Read the full statement (117 words)
TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK®Ti cages is used to facilitate intervertebral body fusion in the cervical spine using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. TRYPTIK®Ti cages is to be used with supplemental fixation that has been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
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/K200312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200312: Tryptik Ti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200312
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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