510(k) · Cleared
ClearedPlateau 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 Jul 19, 2011 as substantially equivalent to K093093 (Life Spine, 2010) and 1 other predicate after a 20-day review. Its family tree reaches back 12 generations to 1984. 120 later devices descend from it.
- Decided
- Jul 19, 2011
- Review
- 20 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K841189 (1984). 40 ancestors in all. 120 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 2 generations backK082801 Phantom Plus Cage SystemUs Spine · 2008
- 1 generation backK093093 Small Plateau Spacer SystemLife Spine · 2010
- This deviceK111835 Plateau Spacer SystemLife Spine, Inc. · 2011
- Descendant · cites it directly · 116 of its ownK121151 Pro-Link Cervical Spacer SystemLife Spine, Inc. · 2012
- Descendant · 2 generations on · 108 of its ownK132029 Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013
- Descendant · 3 generations on · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
- Descendant · 4 generations on · 72 of its ownK200543 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020
- Descendant · 5 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 2 generations backK082801 Phantom Plus Cage SystemUs Spine · 2008
- 1 generation backK093093 Small Plateau Spacer SystemLife Spine · 2010
- This deviceK111835 Plateau Spacer SystemLife Spine, Inc. · 2011
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K121151Pro-Link Cervical Spacer SystemLife Spine, Inc. · 2012 · cites it directly116descendants
- K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013 · 2 generations on108descendants
- K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · 3 generations on93descendants
- K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020 · 4 generations on72descendants
- K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 5 generations on67descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| −2 | K082801 | Phantom Plus Cage System | Us Spine | 2008 | — |
| −1 | K093093 | Small Plateau Spacer System | Life Spine | 2010 | — |
| 0 (this device) | K111835 | Plateau Spacer System | Life Spine, Inc. | 2011 | — |
| +1 | K121151 | Pro-Link Cervical Spacer System | Life Spine, Inc. | 2012 | — |
| +2 | K132029 | Vault-C Intervertebral Body Fusion Device | Spinal USA | 2013 | — |
| +3 | K190546 | NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine, LLC | 2019 | — |
| +4 | K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Nexxt Spine, LLC | 2020 | — |
| +5 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
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 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 13 | 0 |
| 2023 | 19 | 0 |
| 2024 | 19 | 0 |
| 2025 | 25 | 0 |
| 2026 | 21 | 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 |
|---|---|---|---|
| * | K093093 | Small Plateau Spacer System Our reading of the summary gave K093043, FDA’s number for Zirconia Syringe Needle (Kuo Tai Hospital Managements & Consultant Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Plateau Spacer System”. | 2010 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 1…rtebral Body Fusion Device Classification: OP, 21 CFR 888.3080, Class 11 Predicate Device: Plateau Spacer System (K093043), DePuy Bengal System (K08 1917) Device Description: The Smnall PLATEAU Spacer System is intended to serve as an intervertebral body fusion device. The impl… | 2009 |
What descends from it? (120)
See all 1202 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 27 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 40 ancestors have a recall of any class.
- Of its descendants, K121151 (Life Spine, Inc., 2012) has gone furthest, with 116 descendants of its own.
- 2 other devices also cite its predicate K093093.
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. 2011, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K111835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111835: Plateau Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111835
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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