510(k) · Cleared
ClearedTryptik CC Anterior Intersomatic Cervical Cage
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 Oct 4, 2012 as substantially equivalent to K091873 (Spineart, 2009) and 1 other predicate after a 59-day review. Its family tree reaches back 11 generations to 1984. 5 later devices descend from it.
- Decided
- Oct 4, 2012
- Review
- 59 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K841189 (1984). 45 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 2 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 1 generation backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- This deviceK122366 Tryptik CC Anterior Intersomatic Cervical CageSpineart · 2012
- Descendant · cites it directly · 2 of its ownK200312 Tryptik TiSpineart · 2020
- Descendant · cites it directly · 2 of its ownK172065 Scarlet AC-TSpineart · 2017
- Descendant · 2 generations on · 1 of its ownK230583 Tryptik TiSpineart SA · 2023
- Descendant · 2 generations on · 1 of its ownK190322 SCARLET® AC-T Secured Anterior Cervical CageSpineart · 2019
- Descendant · 2 generations on · 0 of its ownK240699 SCARLET® AC-TiSpineart SA · 2024
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 3 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 2 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 1 generation backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- This deviceK122366 Tryptik CC Anterior Intersomatic Cervical CageSpineart · 2012
Most influential descendants
Showing 5 of 5 · See all- K200312Tryptik TiSpineart · 2020 · cites it directly2descendants
- K172065Scarlet AC-TSpineart · 2017 · cites it directly2descendants
- K230583Tryptik TiSpineart SA · 2023 · 2 generations on1descendant
- K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart · 2019 · 2 generations on1descendant
- K240699SCARLET® AC-TiSpineart SA · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −3 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −2 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −1 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| 0 (this device) | K122366 | Tryptik CC Anterior Intersomatic Cervical Cage | Spineart | 2012 | — |
| +1 | K200312 | Tryptik Ti | Spineart | 2020 | — |
| +1 | K172065 | Scarlet AC-T | Spineart | 2017 | — |
| +2 | K230583 | Tryptik Ti | Spineart SA | 2023 | — |
| +2 | K190322 | SCARLET® AC-T Secured Anterior Cervical Cage | Spineart | 2019 | — |
| +2 | K240699 | SCARLET® AC-Ti | Spineart SA | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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.
Planning a device in ODP? 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091873 | Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-SSummary page 1…YPTIK® Anterior Intersomatic Cervical Cage manufactured by Legally marketed SPINEART (K091873); CRYSTAL manufactured by SPINAL ELEMENTS, preicae dvics IC 107351_ALEUTIAN. manufactured by K2M (1<101302)_… | 2009 |
| Kept off the family tree | K107351 | Crystal Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…manufactured by Legally marketed SPINEART (K091873); CRYSTAL manufactured by SPINAL ELEMENTS, preicae dvics IC 107351_ALEUTIAN. manufactured by K2M (1<101302)_ The components added within this submission include lordotic an… | |
| * | K101302 | Aleutian Ibf SystemSummary page 1…manufactured by Legally marketed SPINEART (K091873); CRYSTAL manufactured by SPINAL ELEMENTS, preicae dvics IC 107351_ALEUTIAN. manufactured by K2M (1<101302)_ The components added within this submission include lordotic and convex TRYPTIK… | 2010 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 45 ancestors have a recall of any class.
- Of its descendants, K200312 (Spineart, 2020) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K091873.
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. 2012, 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® cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK® cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK® cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122366: Tryptik CC Anterior Intersomatic Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122366
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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