510(k) · Cleared

Cleared

Vista-S Device, Associated Instrumentation

K133784510(k) TraditionalCleared Jul 7, 2014207-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zimmer Trabecular Metal Technology · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Jul 7, 2014 as substantially equivalent to K111983 (Zimmer Trabecular Metal Technology, 2011) and 3 other predicates after a 207-day review. Its family tree reaches back 9 generations to 2001. 29 later devices descend from it.

Decided: Jul 7, 2014
Review: 207 days
Class: Class II
Product code: ODP
Recalls: None
Predicates: 5

Its longest line of descent runs back 9 generations to K010530 (2001). 25 ancestors in all, the oldest P950002 (1996). 29 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 9 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
5 generations between
3 generations backK082406 Expandable Peek-Optima ImplantEbi, L.P. · 2009
2 generations backK092336 C-Thru Spinal SystemEbi, L.P. · 2009
1 generation backK111983 Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology · 2011
This deviceK133784 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
Descendant · cites it directly · 6 of its ownK222004 INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023

Show all 9 generations

Root · 9 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
8 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
7 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
6 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
5 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
4 generations backK081636 Peek-Optima Alif SpacerBiomet Spine · 2008
3 generations backK082406 Expandable Peek-Optima ImplantEbi, L.P. · 2009
2 generations backK092336 C-Thru Spinal SystemEbi, L.P. · 2009
1 generation backK111983 Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology · 2011
This deviceK133784 Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology · 2014

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2015high 5 (2024) · low 1 (2015)2026

Most influential descendants

Showing 5 of 29 · See all

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
K222004INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023 · cites it directly6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K010530	Geo Structure	Interpore Cross Intl.	2001	—
−8	K062083	Synfix -LR	Synthes Spine Co.Lp	2007	—
−7	K072253	Synfix-LR Spacer	Synthes Spine Co.Lp	2007	1
−6	K073470	Avs PL Peek Spacers, Models 48351XXX and 48353XXX	Stryker Spine	2008	—
−5	K080758	Avs PL Peek Spacers, Models 48351 and 48353	Stryker Corp.	2008	—
−4	K081636	Peek-Optima Alif Spacer	Biomet Spine	2008	—
−3	K082406	Expandable Peek-Optima Implant	Ebi, L.P.	2009	—
−2	K092336	C-Thru Spinal System	Ebi, L.P.	2009	—
−1	K111983	Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx	Zimmer Trabecular Metal Technology	2011	—
0 (this device)	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	—
+1	K222004	INTEGRATE -C Interbody Fusion System	Happe Spine	2023	—

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
2015	1	0
2016	1	0
2017	2	0
2018	1	0
2019	1	0
2020	1	0
2021	3	0
2022	2	0
2023	3	0
2024	5	0
2025	4	0
2026	5	0

FIG. 1 — Lineage of K133784, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K111983	Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx Summary page 1 …Vista®-S Device was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include this Vista®-S Device as an 1SF and VBR (KI 111983 and K070382), TM-S Fusion Device by Zimmer (K] 11119 and K 103033), and Alphatec Spine Novel XS (K08 1730). The Vistalo-S Device…	Zimmer Trabecular Metal Technology	2011	—
*	K070382	Vista -S Device Summary page 1 …evice was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include this Vista®-S Device as an 1SF and VBR (KI 111983 and K070382), TM-S Fusion Device by Zimmer (K] 11119 and K 103033), and Alphatec Spine Novel XS (K08 1730). The Vistalo-S Device has the ide…	Zimmer Trabecular Metal Technology	2007	—
Kept off the family tree	K111119	FDA’s K111119 is Trabecular Metal (TM) Fusion Device Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Zimmer Spine, Inc.	2011	—
*	K103033	Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx Summary page 1 …ally marketed predicate devices. The predicate devices include this Vista®-S Device as an 1SF and VBR (KI 111983 and K070382), TM-S Fusion Device by Zimmer (K] 11119 and K 103033), and Alphatec Spine Novel XS (K08 1730). The Vistalo-S Device has the identical material as previously cleared predicate device…	Zimmer Trabecular Metal Technology	2011	—
*	K081730	Novel Cervical Spinal Spacer System Summary page 1 …dicate devices include this Vista®-S Device as an 1SF and VBR (KI 111983 and K070382), TM-S Fusion Device by Zimmer (K] 11119 and K 103033), and Alphatec Spine Novel XS (K08 1730). The Vistalo-S Device has the identical material as previously cleared predicate devices. The intended use and indications for…	Alphatec Spine, Inc.	2008	—

Also cleared against K111983: 3 other devices →

What descends from it? (29)

See all 29

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K143297	Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…	Zimmer Spine, Inc.	2015	19
K222004	INTEGRATE -C Interbody Fusion System	Happe Spine	2023	6
K211501	Advantage-C PEEK Cervical lnterbody Fusion Device	Lntelivation, LLC	2021	1

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 13 years and passes through 7 companies; a new generation was cleared every 6 months on median.
2 of the 25 ancestors have a recall of any class.
Of its descendants, K143297 (Zimmer Spine, Inc., 2015) has gone furthest, with 19 descendants of its own.
3 other devices also cite its predicate K111983.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2007high 187 (2013) · low 76 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ODP

2in 2025

2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ODP

57in 2025

2007high 161 (2021) · low 0 (2007)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-T1. 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133784 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133784: Vista-S Device, Associated Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133784

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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