510(k) · Cleared
ClearedThe Small PLATEAU (PLATEAU-C) Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 22, 2016 as substantially equivalent to K111835 (Life Spine, Inc., 2011) and 1 other predicate after a 245-day review. Its family tree reaches back 13 generations to 2001. 6 later devices descend from it.
- Decided
- Dec 22, 2016
- Review
- 245 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K003155 (2001). 67 ancestors in all, the oldest K841189 (1984). 6 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 1 generation backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- This deviceK161127 The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK180642 Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK173128 Alamo® CAlliance Partners, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK252737 DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical · 2025
- Descendant · 2 generations on · 0 of its ownK231704 Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK213115 CHENA-C Spacer SystemKahtnu Surgical, Inc. · 2021
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 7 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 6 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 5 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 4 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 1 generation backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- This deviceK161127 The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc. · 2018 · cites it directly2descendants
- K173128Alamo® CAlliance Partners, LLC · 2018 · cites it directly2descendants
- K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical · 2025 · 2 generations on0descendants
- K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc. · 2023 · 2 generations on0descendants
- K213115CHENA-C Spacer SystemKahtnu Surgical, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −7 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −3 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −2 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −1 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| 0 (this device) | K161127 | The Small PLATEAU (PLATEAU-C) Spacer System | Life Spine, Inc. | 2016 | — |
| +1 | K180642 | Pro-Link® Ti Stand-Alone Cervical Spacer System | Life Spine, Inc. | 2018 | — |
| +1 | K173128 | Alamo® C | Alliance Partners, LLC | 2018 | — |
| +2 | K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical | 2025 | — |
| +2 | K231704 | Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System | Life Spine, Inc. | 2023 | — |
| +2 | K213115 | CHENA-C Spacer System | Kahtnu Surgical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 8 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K111835 | Plateau Spacer SystemSummary page 4…pacer System Common Name: Intervertebral Body Fusion Device Classification: ODP, 21 CFR 888.3080, Class II Primary Predicate : Small PLATEAU (PLATEAU-C) Spacer System (K111835) Additional Predicate: Titan Spine Endoskeleton TC IBF (K100889) Device Description: The Small PLATEAU (PLATEAU-C) Spacer Syst… | 2011 |
| * | K100889 | Endoskeleton TCSummary page 4…sification: ODP, 21 CFR 888.3080, Class II Primary Predicate : Small PLATEAU (PLATEAU-C) Spacer System (K111835) Additional Predicate: Titan Spine Endoskeleton TC IBF (K100889) Device Description: The Small PLATEAU (PLATEAU-C) Spacer System is intended to serve as an intervertebral body fusion device.… | 2010 |
What descends from it? (6)
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 15 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 3 of the 67 ancestors have a recall of any class.
- Of its descendants, K180642 (Life Spine, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K111835.
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. 2016, 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 Small PLATEAU (PLATEAU-C) Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.
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/K161127 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161127: The Small PLATEAU (PLATEAU-C) 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/K161127
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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