510(k) · Cleared
ClearedSpinesmith Cimplicity Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Smith Partners L.P. · MQP Spinal Vertebral Body Replacement Device
Cleared on Jul 2, 2008 as substantially equivalent to K073320 (Spine Smith Partners L.P., 2008) and 2 other predicates after an 89-day review. Its family tree reaches back 7 generations to 1984. 406 later devices descend from it.
- Decided
- Jul 2, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K841189 (1984). 26 ancestors in all. 406 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 5 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 4 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 2 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 1 generation backK043479 MC+ Partial VBRLdr Spine USA · 2005
- This deviceK080971 Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P. · 2008
- Descendant · cites it directly · 405 of its ownK122630 IN:C2 Spinal Fixation SystemSpine Smith Partners L.P. · 2012
- Descendant · 2 generations on · 330 of its ownK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- Descendant · 3 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 4 generations on · 169 of its ownK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- Descendant · 2 generations on · 155 of its ownK142218 Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015
Showing 5 of 406 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 406 · See all- K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P. · 2012 · cites it directly405descendants
- K133494Chesapeake Spinal SystemK2m, Inc. · 2014 · 2 generations on330descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 3 generations on315descendants
- K162264Cascadia Interbody SystemK2m, Inc. · 2016 · 4 generations on169descendants
- K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015 · 2 generations on155descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −6 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −5 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −4 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −2 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −1 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| 0 (this device) | K080971 | Spinesmith Cimplicity Spinal System | Spine Smith Partners L.P. | 2008 | — |
| +1 | K122630 | IN:C2 Spinal Fixation System | Spine Smith Partners L.P. | 2012 | — |
| +2 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| +3 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +4 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| +2 | K142218 | Coalition AGX Plate and Coalition AGX Spacer | Globus Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 17 | 0 |
| 2018 | 15 | 0 |
| 2019 | 21 | 0 |
| 2020 | 41 | 0 |
| 2021 | 38 | 0 |
| 2022 | 50 | 0 |
| 2023 | 55 | 0 |
| 2024 | 52 | 0 |
| 2025 | 52 | 0 |
| 2026 | 48 | 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 MQP? 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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 |
|---|---|---|---|
| * | K073320 | Cimplicity Spinal SystemSummary page 1…evice (ODP) PROPRIETARY NAME SpineSmith Cimplicity Spinal System PREDICATE DEVICE(S) SpineSmith Cimplicity Spinal System (K073320) LDR Spine MC+ (K043479) Spinal Elements, Inc.… | 2008 |
| * | K043479 | MC+ Partial VBRSummary page 1…Cimplicity Spinal System PREDICATE DEVICE(S) SpineSmith Cimplicity Spinal System (K073320) LDR Spine MC+ (K043479) Spinal Elements, Inc. Crystal (K073351) SUBSTANTIAL EQUIVALENCE… | 2005 |
| * | K073351 | CrystalSummary page 1…mplicity Spinal System (K073320) LDR Spine MC+ (K043479) Spinal Elements, Inc. Crystal (K073351) SUBSTANTIAL EQUIVALENCE The SpineSmith Cimplicity System was determined to be… | 2008 |
What descends from it? (406)
See all 4061 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122630 | IN:C2 Spinal Fixation System | 2012 | 405 |
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 24 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K122630 (Spine Smith Partners L.P., 2012) has gone furthest, with 405 descendants of its own.
- 1 other device also cites its predicate K073320.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The Cimplicity System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Cimplicity device is intended for use in the thoracolumbar spine (from TI to L5) and is intended for use with supplemental internal fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the…
Read the full statement (197 words)
The Cimplicity System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Cimplicity device is intended for use in the thoracolumbar spine (from TI to L5) and is intended for use with supplemental internal fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.
When used as an intervertebral body fusion device, the Cimplicity System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with a Cimplicity interbody fusion device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080971: Spinesmith Cimplicity Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080971
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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