510(k) · Cleared
ClearedTailored-C Cervical Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bespoke Technologies · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 28, 2020 as substantially equivalent to K162496 (Corelink, LLC, 2017) and 3 other predicates after a 307-day review. Its family tree reaches back 21 generations to 1984. 1 of the 323 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Dec 28, 2020
- Review
- 307 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 21 generations to K841189 (1984). 319 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 3 citing it directly. 1 of the 323 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 2 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 1 generation backK170318 NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC · 2017
- This deviceK200458 Tailored-C Cervical Interbody Fusion SystemBespoke Technologies · 2020
- Descendant · cites it directly · 0 of its ownK230607 SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK222903 Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC · 2022
- Descendant · cites it directly · 0 of its ownK212450 Keos Anterior Cervical Interbody Fusion Device SystemKeos · 2022
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 4 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 3 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 2 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 1 generation backK170318 NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC · 2017
- This deviceK200458 Tailored-C Cervical Interbody Fusion SystemBespoke Technologies · 2020
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 3 of 3 · See all- K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd. · 2023 · cites it directly0descendants
- K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC · 2022 · cites it directly0descendants
- K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −11 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −10 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −9 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −8 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −7 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −6 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −5 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −4 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −3 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −2 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −1 | K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | Ht Medical, LLC | 2017 | — |
| 0 (this device) | K200458 | Tailored-C Cervical Interbody Fusion System | Bespoke Technologies | 2020 | — |
| +1 | K230607 | SPICCA Cervical Fusion Cages | Southern Medical (Pty), Ltd. | 2023 | — |
| +1 | K222903 | Tailored-H Cervical Stand Alone System | Bespoke Technologies, LLC | 2022 | — |
| +1 | K212450 | Keos Anterior Cervical Interbody Fusion Device System | Keos | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 16 | 0 |
| 2004 | 25 | 0 |
| 2005 | 17 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 44 | 1 |
| 2009 | 33 | 0 |
| 2010 | 19 | 0 |
| 2011 | 28 | 0 |
| 2012 | 19 | 0 |
| 2013 | 15 | 0 |
| 2014 | 15 | 0 |
| 2015 | 10 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K162496 | Foundation 3D InterbodySummary page 5…Trade or Proprietary or Manufacturer Predicate Model Name Type K162496 Foundation™ 3D Interbody CoreLink LLC Primary K173347 ACTLIF C FLX™… | 2017 |
| * | K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Summary page 5…Model Name Type K162496 Foundation™ 3D Interbody CoreLink LLC Primary K173347 ACTLIF C FLX™ Centinel Spine Additional K120275 Synthes ACIS… | 2018 |
| * | K120275 | Synthes Acis/Vertebral Spacer CRSummary page 5…Foundation™ 3D Interbody CoreLink LLC Primary K173347 ACTLIF C FLX™ Centinel Spine Additional K120275 Synthes ACIS Synthes (USA) LLC Additional K170318 NeoFuse™ Ti3… | 2012 |
| * | K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical InterbodySummary page 5…ACTLIF C FLX™ Centinel Spine Additional K120275 Synthes ACIS Synthes (USA) LLC Additional K170318 NeoFuse™ Ti3D HT Medical, LLC Additional PLIF/TLIF/Ce… | 2017 |
What descends from it? (3)
3 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 · 4 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 15 companies; a new generation was cleared every 10 months on median.
- 38 of the 319 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K230607 (Southern Medical (Pty), Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K162496.
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?
The Tailored-C Cervical Interbody Fusion Devices 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. Tailored-C Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an…
Read the full statement (106 words)
The Tailored-C Cervical Interbody Fusion Devices 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. Tailored-C Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Tailored-C Cervical implants 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.
https://510kreport.com/device/K200458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200458: Tailored-C Cervical Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200458
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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