510(k) · Cleared
ClearedChoiceSpine Stealth Cervical Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine, LP · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Mar 6, 2019 as substantially equivalent to K091531 (Choice Spine, Llp, 2009) and 2 other predicates after an 89-day review. Its family tree reaches back 21 generations to 1984. 1 of the 327 devices in its family, counting itself, has a Class I recall. 16 later devices descend from it.
- Decided
- Mar 6, 2019
- Review
- 89 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 21 generations to K841189 (1984). 310 ancestors in all. 16 later devices descend from it, 3 citing it directly. 1 of the 327 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 backK160916 CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
- 2 generations backK162138 NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated · 2016
- 1 generation backK172676 NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated · 2017
- This deviceK183397 ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP · 2019
- Descendant · cites it directly · 9 of its ownK202398 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021
- Descendant · 2 generations on · 6 of its ownK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
- Descendant · cites it directly · 4 of its ownK201643 ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC · 2020
- Descendant · 3 generations on · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
- Descendant · 2 generations on · 3 of its ownK212811 Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC · 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 backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK160916 CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
- 2 generations backK162138 NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated · 2016
- 1 generation backK172676 NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated · 2017
- This deviceK183397 ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP · 2019
Showing 5 of 16 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 16 · See all- K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021 · cites it directly9descendants
- K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022 · 2 generations on6descendants
- K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC · 2020 · cites it directly4descendants
- K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · 3 generations on3descendants
- K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC · 2022 · 2 generations on3descendants
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 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K160916 | CoRoent® Ti-C System | Nu Vasive, Incorporated | 2016 | — |
| −2 | K162138 | NuVasive CoRoent Small Ti-C System | Nu Vasive, Incorporated | 2016 | — |
| −1 | K172676 | NuVasive® Modulus-C Interbody System | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K183397 | ChoiceSpine Stealth Cervical Spacer System | Choicespine, LP | 2019 | — |
| +1 | K202398 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2021 | — |
| +2 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022 | — |
| +1 | K201643 | ChoiceSpine Tiger Shark Cervical Spacer System | Choice Spine, LLC | 2020 | — |
| +3 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | — |
| +2 | K212811 | Ti3Z Lumbar Interbody System | Zavation Medical Products, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 16 | 0 |
| 2004 | 23 | 0 |
| 2005 | 19 | 0 |
| 2006 | 9 | 0 |
| 2007 | 14 | 0 |
| 2008 | 40 | 1 |
| 2009 | 29 | 0 |
| 2010 | 21 | 0 |
| 2011 | 25 | 0 |
| 2012 | 12 | 0 |
| 2013 | 16 | 0 |
| 2014 | 20 | 0 |
| 2015 | 10 | 0 |
| 2016 | 7 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K091531 | Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody SpacerSummary page 5…is made from 455/465 SS per ASTM A564 and 17-4 SS per ASTM F899. Predicate Device Primary predicate: Choice Spine Cervical Interbody Spacer System (K091531), Additional Predicate: Choice Spine Tiger Shark System (K172816) Additional Predicate:NuVa… | 2009 |
| * | K172816 | TiGer Shark™ SystemSummary page 5…Predicate Device Primary predicate: Choice Spine Cervical Interbody Spacer System (K091531), Additional Predicate: Choice Spine Tiger Shark System (K172816) Additional Predicate:NuVasive Modulus-C Interbody System (K172676) Substantial The implants proposed… | 2018 |
| * | K172676 | NuVasive® Modulus-C Interbody SystemSummary page 5…K091531), Additional Predicate: Choice Spine Tiger Shark System (K172816) Additional Predicate:NuVasive Modulus-C Interbody System (K172676) Substantial The implants proposed in this submission are similar to the predicate devices in Equivalence principl… | 2017 |
What descends from it? (16)
See all 163 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 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 38 of the 310 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K202398 (Zavation Medical Products, LLC, 2021) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K091531.
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. 2019, 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 ChoiceSpine Stealth™ Cervical Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc space to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stealth™ Cervical Spacer System is to be used with supplemental fixation and with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion.
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/K183397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183397: ChoiceSpine Stealth Cervical Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183397
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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