510(k) · Cleared

Recalled · Class II · 2016

Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System

K971883510(k) TraditionalCleared Oct 16, 1997147-day reviewClass II21 CFR 888.3060Recalls 1

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

Synthes (Usa) · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Oct 16, 1997 as substantially equivalent to K945700 (Synthes (Usa), 1995) and 1 other predicate after a 147-day review. Its family tree reaches back 1 generation to 1993. 1 of the 534 devices in its family, counting itself, has a Class I recall. 531 later devices descend from it. It has been recalled once.

Decided: Oct 16, 1997
Review: 147 days
Class: Class II
Product code: KWQ
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K926453 (1993). 2 ancestors in all. 531 later devices descend from it, 16 citing it directly. 1 of the 534 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
This deviceK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997
Descendant · cites it directly · 348 of its ownK103287 Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011
Descendant · 2 generations on · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
Descendant · 3 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
Descendant · 2 generations on · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
Descendant · 3 generations on · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015

Showing 5 of 531 descendants. See all descendants

Descendants cleared per year

2002high 61 (2023) · low 1 (2006)2026

Class I recalls in this family

K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 531 · See all

K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011 · cites it directly348descendants
K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · 2 generations on260descendants
K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 3 generations on225descendants
K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 2 generations on172descendants
K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 3 generations on158descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K926453	Synthes (U.S.a.) Anterior Cervical Vertebrae Plate	Synthes (Usa)	1993	—
0 (this device)	K971883	Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System	Synthes (Usa)	1997	—
+1	K103287	Synthes 6.0 Cocr and CPT TI-3 Rods	Synthes Spine	2011	—
+2	K113395	Revere 4.5 Stabilization System	Globus Medical, Inc.	2012	—
+3	K122226	Revere Stabilization System	Globus Medical, Inc.	2012	—
+2	K124058	Creo Stabilization System	Globus Medical, Inc.	2013	—
+3	K143633	CREO Stabilization System	Globus Medical, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	4	0
2003	3	0
2004	3	0
2005	5	0
2006	1	0
2007	1	0
2008	4	0
2009	2	0
2010	3	0
2011	7	0
2012	17	0
2013	12	0
2014	16	0
2015	25	0
2016	18	0
2017	31	0
2018	26	0
2019	31	0
2020	29	0
2021	33	1
2022	39	0
2023	61	0
2024	59	0
2025	51	0
2026	50	0

FIG. 1 — Lineage of K971883, 1993–2026Source: 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.

1 device in this family has a Class I recall. 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 KWQ device

#1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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? (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	Applicant	Decided	Recalls
*	K945700	Synthes (Usa) Anterior Cervical Vertebrae Plate System Summary page 1 …re Anterior Cervical Vertebrae Plate System (as part of the Anterior Cervical Vertebrae Plate Systemn) compared to the Synthes Anterior Cervical Vertebrae Plate System (K945700 & K926453). The Synthes Small Stature Anterior Cervical Vertebrae Plate consists of a plate with at least 4 screws and is manufa…	Synthes (Usa)	1995	—
*	K926453	Synthes (U.S.a.) Anterior Cervical Vertebrae Plate Summary page 1 …r Cervical Vertebrae Plate System (as part of the Anterior Cervical Vertebrae Plate Systemn) compared to the Synthes Anterior Cervical Vertebrae Plate System (K945700 & K926453). The Synthes Small Stature Anterior Cervical Vertebrae Plate consists of a plate with at least 4 screws and is manufacrured fro…	Synthes (Usa)	1993	—

Also cleared against K945700: 23 other devices →

What descends from it? (531)

See all 531

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

Number	Device	Applicant	Decided	Descendants
K103287	Synthes 6.0 Cocr and CPT TI-3 Rods	Synthes Spine	2011	348
K012184	Blackstone Iii Anterior Cervical Plating System	Blackstone Medical, Inc.	2002	85
K030595	Blackstone Fusion Anterior Cervical Plating System	Blackstone Medical, Inc.	2003	66
K051665	Synthes Vectra-T System	Synthes Spine	2005	49
K022344	Trinica Select Anterior Cervical Plate System	Centerpulse Spine-Tech, Inc.	2002	43
K063544	Modification to Pyrenees Cervical Plate System	K2m, Inc.	2007	38
K043066	Pioneer Anterior Cervical Plate System	Pioneer Surgical Technology	2005	27
K111796	Invizia Anterior Cervical Plate System	Zimmer Spine, Inc.	2011	18
K051815	Modification to Vertebron SCP Cervical Plate System	Vertebron, Inc.	2005	10
K092474	Pyrenees Cervical Plate System, Semi-Constrained Screws	K2m, Inc.	2010	8

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 6, 2016	Class II	Z-1524-2016	Packaging process control	DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System due to discovery of a single lot of…

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K103287 (Synthes Spine, 2011) has gone furthest, with 348 descendants of its own.
23 other devices also cite its predicate K945700.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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	27	101	2	288
2008	32	70	33	348
2009	23	90	35	355
2010	23	104	2	691
2011	22	95	5	415
2012	26	90	7	544
2013	22	88	6	796
2014	17	124	0	546
2015	25	102	2	562
2016	15	121	9	502
2017	20	67	8	492
2018	22	95	1	341
2019	26	81	0	298
2020	26	55	0	400
2021	17	59	0	591
2022	18	85	0	392
2023	16	59	0	320
2024	17	64	0	419
2025	7	64	0	248
2026	10	76	0	—

What is it indicated for?

The Small Stature Anterior Cervical Vertebrae Plate System (as part of the Anterior Cervical Vertebrae Plate System) is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications:

1. Spondylolisthesis

2. Fracture

3. Spinal stenosis

4. Tumor

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/K971883 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971883

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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