510(k) · Cleared
ClearedVista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Trabecular Metal Technology · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 18, 2011 as substantially equivalent to K070382 (Zimmer Trabecular Metal Technology, 2007) and 4 other predicates after a 129-day review. Its family tree reaches back 8 generations to 2001. 31 later devices descend from it.
- Decided
- Nov 18, 2011
- Review
- 129 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K010530 (2001). 24 ancestors in all, the oldest P950002 (1996). 31 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 7 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 6 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 5 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 4 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 3 generations backK081636 Peek-Optima Alif SpacerBiomet Spine · 2008
- 2 generations backK082406 Expandable Peek-Optima ImplantEbi, L.P. · 2009
- 1 generation backK092336 C-Thru Spinal SystemEbi, L.P. · 2009
- This deviceK111983 Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology · 2011
- Descendant · cites it directly · 29 of its ownK133784 Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology · 2014
- Descendant · cites it directly · 19 of its ownK143297 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior…Zimmer Spine, Inc. · 2015
- Descendant · 2 generations on · 11 of its ownK162986 SPIRA Open Matrix ALIFCamber Spine Technologies · 2017
- Descendant · 3 generations on · 10 of its ownK180724 SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018
- Descendant · 3 generations on · 9 of its ownK190483 SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies · 2019
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology · 2014 · cites it directly29descendants
- K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc. · 2015 · cites it directly19descendants
- K162986SPIRA Open Matrix ALIFCamber Spine Technologies · 2017 · 2 generations on11descendants
- K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018 · 3 generations on10descendants
- K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies · 2019 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −7 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −6 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −5 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −4 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −3 | K081636 | Peek-Optima Alif Spacer | Biomet Spine | 2008 | — |
| −2 | K082406 | Expandable Peek-Optima Implant | Ebi, L.P. | 2009 | — |
| −1 | K092336 | C-Thru Spinal System | Ebi, L.P. | 2009 | — |
| 0 (this device) | K111983 | Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx | Zimmer Trabecular Metal Technology | 2011 | — |
| +1 | K133784 | Vista-S Device, Associated Instrumentation | Zimmer Trabecular Metal Technology | 2014 | — |
| +1 | K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical… | Zimmer Spine, Inc. | 2015 | — |
| +2 | K162986 | SPIRA Open Matrix ALIF | Camber Spine Technologies | 2017 | — |
| +3 | K180724 | SPIRA Open Matrix LLIF | Camber Spine Technologies, LLC | 2018 | — |
| +3 | K190483 | SPIRA Open Matrix ALIF and LLIF | Camber Spine Technologies | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (5)
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 |
|---|---|---|---|
| * | K070382 | Vista -S DeviceSummary page 2…ice(s): The Vista®-S Device was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include this Vista®-S Device as a VBR (K070382), C-Thru by EBI (K092336), NUBIC by SIGNUS (K082848), TM-S Fusion Device by Zimmer TMT (K 103033), and Vista®-P Device by Zimmer… | 2007 |
| * | K092336 | C-Thru Spinal SystemSummary page 2…ice was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include this Vista®-S Device as a VBR (K070382), C-Thru by EBI (K092336), NUBIC by SIGNUS (K082848), TM-S Fusion Device by Zimmer TMT (K 103033), and Vista®-P Device by Zimmer TMT (K061 155). The Vist… | 2009 |
| * | K082848 | Nubic and Rabea DevicesSummary page 2…tially equivalent to legally marketed predicate devices. The predicate devices include this Vista®-S Device as a VBR (K070382), C-Thru by EBI (K092336), NUBIC by SIGNUS (K082848), TM-S Fusion Device by Zimmer TMT (K 103033), and Vista®-P Device by Zimmer TMT (K061 155). The Vista®-S Device has the identic… | 2009 |
| * | K103033 | Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-XxxxxSummary page 2…ate devices. The predicate devices include this Vista®-S Device as a VBR (K070382), C-Thru by EBI (K092336), NUBIC by SIGNUS (K082848), TM-S Fusion Device by Zimmer TMT (K 103033), and Vista®-P Device by Zimmer TMT (K061 155). The Vista®-S Device has the identical material as previously cleared predicate d… | 2011 |
| * | K061155 | Vista P Vertebral Body Replacement SystemSummary page 2…s Vista®-S Device as a VBR (K070382), C-Thru by EBI (K092336), NUBIC by SIGNUS (K082848), TM-S Fusion Device by Zimmer TMT (K 103033), and Vista®-P Device by Zimmer TMT (K061 155). The Vista®-S Device has the identical material as previously cleared predicate devices. The intended use and indications for u… | 2006 |
What descends from it? (31)
See all 314 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 10 years and passes through 7 companies; a new generation was cleared every 6 months on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K133784 (Zimmer Trabecular Metal Technology, 2014) has gone furthest, with 29 descendants of its own.
- 1 other device also cites its predicate K070382.
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 Vista®-S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista®-S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft.…
Read the full statement (134 words)
The Vista®-S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista®-S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista®-S Device is implanted via an anterior approach.
The Vista®-S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista®-s Device is intended for use with supplemental internal spinal fixation systems. The Vista®-S Device may be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111983: Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111983
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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