510(k) · Cleared

Cleared

Centaur Spinal System

K994347510(k) TraditionalCleared Mar 15, 200083-day reviewClass II21 CFR 888.3060

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

Howmedica Osteonics Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Mar 15, 2000 as substantially equivalent to K983583 (Depuy, Inc., 1998) after an 83-day review. Its family tree reaches back 1 generation to 1998. 343 later devices descend from it.

Decided: Mar 15, 2000
Review: 83 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K983583 (1998). 343 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK983583 Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc. · 1998
This deviceK994347 Centaur Spinal SystemHowmedica Osteonics Corp. · 2000
Descendant · cites it directly · 254 of its ownK002824 Macs Modular Anterior Construct SystemAesculap, Inc. · 2001
Descendant · 2 generations on · 250 of its ownK032059 Modification to Macs Modular Anterior Construct SystemAesculap, Inc. · 2003
Descendant · 3 generations on · 248 of its ownK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
Descendant · 4 generations on · 218 of its ownK102249 Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010
Descendant · 4 generations on · 203 of its ownK111571 Viper SystemsJohnson & Johnson · 2011

Showing 5 of 343 descendants. See all descendants

Descendants cleared per year

2001high 47 (2023) · low 0 (2002)2026

Most influential descendants

Showing 5 of 343 · See all

K002824Macs Modular Anterior Construct SystemAesculap, Inc. · 2001 · cites it directly254descendants
K032059Modification to Macs Modular Anterior Construct SystemAesculap, Inc. · 2003 · 2 generations on250descendants
K070387Expedium Spine SystemDepuy Spine, Inc. · 2007 · 3 generations on248descendants
K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010 · 4 generations on218descendants
K111571Viper SystemsJohnson & Johnson · 2011 · 4 generations on203descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K983583	Depuy Acromed Moss and Moss Miami Spinal Systems	Depuy, Inc.	1998	—
0 (this device)	K994347	Centaur Spinal System	Howmedica Osteonics Corp.	2000	—
+1	K002824	Macs Modular Anterior Construct System	Aesculap, Inc.	2001	—
+2	K032059	Modification to Macs Modular Anterior Construct System	Aesculap, Inc.	2003	—
+3	K070387	Expedium Spine System	Depuy Spine, Inc.	2007	—
+4	K102249	Expedium Spine System	Depuy Spine, A Johnson & Johnson Company	2010	—
+4	K111571	Viper Systems	Johnson & Johnson	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2007	1	0
2008	4	0
2009	2	0
2010	1	0
2011	2	0
2012	6	0
2013	14	0
2014	13	0
2015	14	0
2016	11	0
2017	8	0
2018	22	0
2019	20	0
2020	19	0
2021	17	0
2022	29	0
2023	47	0
2024	39	0
2025	36	0
2026	36	0

FIG. 1 — Lineage of K994347, 1998–2026Source: 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 KWQ? 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

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What was it cleared against? (1)

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
*	K983583	Depuy Acromed Moss and Moss Miami Spinal Systems Summary page 1 …Spinal System are substantially equivalent to the features of the following DePuy AcroMed predicate device, which has been cleared for marketing via the 510(k) process (K983583): : ® MOSS Miami Spinal System Device Description The Centaur" Spinal System is a spinal fixation device for the noncervical s…	Depuy, Inc.	1998	—

Also cleared against K983583: 25 other devices →

What descends from it? (343)

See all 343

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

Number	Device	Applicant	Decided	Descendants
K002824	Macs Modular Anterior Construct System	Aesculap, Inc.	2001	254
K073437	Thor Anterior Plating System	Stryker Spine	2008	102
K080773	Thor Anterior Plating System	Stryker Spine	2008	101
K142699	LITe Plate System	Stryker Corporation	2014	46
K150449	LITe Plate System	Stryker Corp.	2015	24

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?

Its one ancestor has no recall.
Of its descendants, K002824 (Aesculap, Inc., 2001) has gone furthest, with 254 descendants of its own.
25 other devices also cite its predicate K983583.

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?

When used as an anterior, thoracic/lumbar screw fixation system, the Centaur™ Spinal System is intended to treat deformities of curvature (i.e. scoliosis, kyphosis and/or lordosis), fracture, tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e.discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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/K994347 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994347: Centaur 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/K994347

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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