510(k) Report

510(k) · Cleared

Cleared

Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-S

K091873510(k) AbbreviatedCleared Sep 18, 200987-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spineart · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Sep 18, 2009 as substantially equivalent to P000028 (Medtronic Sofamor Danek USA, Inc., 2002) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 2001. 106 later devices descend from it.

Decided
Sep 18, 2009
Review
87 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to P980048 (2001). 3 ancestors in all. 106 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2002: 1 other ancestor2010: 1 descendant cleared2020: 8 descendants cleared2016: 2 descendants cleared2012: 4 descendants cleared2017: 7 descendants cleared2019: 4 descendants cleared2023: 15 descendants cleared2011: 2 descendants cleared2015: 3 descendants cleared2026: 14 descendants cleared2018: 2 descendants cleared2024: 16 descendants cleared2014: 1 descendant cleared2021: 5 descendants cleared2025: 14 descendants cleared2022: 8 descendants clearedP980048 · Bak/Cervical (Bak/C) Interbody Fusion System · Sulzer Spine-Tech · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 10 descendants2 generations forward: 18 descendants3 generations forward: 14 descendants4 generations forward: 15 descendants5 generations forward: 25 descendants6 generations forward: 18 descendants7 generations forward: 6 descendants P980048 · Bak/Cervical (Bak/C) Interbody Fusion System · Sulzer Spine-Tech · 20010+5
  1. Root · 1 generation backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
  2. This deviceK091873 Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12…Spineart · 2009
  3. Descendant · cites it directly · 78 of its ownK101363 VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers · 2010
  4. Descendant · 2 generations on · 62 of its ownK111675 VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2011
  5. Descendant · 2 generations on · 61 of its ownK172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
  6. Descendant · 2 generations on · 60 of its ownK183083 Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019
  7. Descendant · 3 generations on · 39 of its ownK210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2021

Showing 5 of 106 descendants. See all descendants

Descendants cleared per year

2010: 12011: 22012: 42014: 12015: 32016: 22017: 72018: 22019: 42020: 82021: 52022: 82023: 152024: 162025: 142026: 14
2010high 16 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 106 · See all
  • K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers · 2010 · cites it directly78descendants
  • K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2011 · 2 generations on62descendants
  • K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017 · 2 generations on61descendants
  • K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019 · 2 generations on60descendants
  • K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation · 2021 · 3 generations on39descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P980048Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech2001—
0 (this device)K091873Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA…Spineart2009—
+1K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers2010—
+2K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC2011—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation2017—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation2019—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo…SeaSpine Orthopedics Corporation2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201240
201410
201530
201620
201770
201820
201940
202080
202150
202280
2023150
2024160
2025140
2026140
FIG. 1 — Lineage of K091873, 2001–2026Source: 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 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. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*P000028Affinity (TM) Cage System
Summary page 1
…nel Orthope08dic AFFINIT ANTERIOR CERVICAL CAGE SYSTEM (P000028) manufactured by MEDTRONIC, BAK/C ]Legally marketed CERVICAL I…
Medtronic Sofamor Danek USA, Inc.2002—
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 1
…000028) manufactured by MEDTRONIC, BAK/C ]Legally marketed CERVICAL INTERBODY FUSION DEVICE (P980048) predicate devices manufactured by ZIMMER SPINE, CRYSTAL (K073351)…
Sulzer Spine-Tech2001—
*K073351Crystal
Summary page 1
…CERVICAL INTERBODY FUSION DEVICE (P980048) predicate devices manufactured by ZIMMER SPINE, CRYSTAL (K073351) manufactured by SPINAL ELEMENTS, INC TRYPTIK ca of…
Spinal Elements, Inc.2008—

Also cleared against P000028: 15 other devices →

What descends from it? (106)

See all 106

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078
K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214
K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612
K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125
K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123
K200312Tryptik TiSpineart20202
K172065Scarlet AC-TSpineart20172
K112801Ayers Rock Cervical CageQualgenix20122
K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171
K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K101363 (Musculoskeletal Clinical Regulatory Advisers, 2010) has gone furthest, with 78 descendants of its own.
  • 15 other devices also cite its predicate P000028.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

TRYPTIK®ca 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®ca are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK®ca are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage

Indications for use as stated in the FDA summary.

Also cleared against P000028

15 other devices cite the same predicate.

  • K173148ACIFColigne AG · 2017
  • K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
  • K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014
  • K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  • K120819Stalif CCentinel Spine, Inc. · 2012
  • K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd. · 2012

More from Spineart

44 FDA decisions under this applicant name. See the company

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  • K213470PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022
  • K210472SPINEART Navigation Instrument SystemSpineart · 2021
  • K203506PERLA® TL posterior osteosynthesis systemSpineart · 20212 recalls
  • K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K091873 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091873: Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091873

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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