510(k) · Cleared

Cleared

K-Centrum Anterior Spinal Fixation System

K990959510(k) AbbreviatedCleared Dec 27, 1999280-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

Spineology, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 27, 1999 as substantially equivalent to K922543 (Sofamor Danek Mfg., Inc., 1993) after a 280-day review. Its family tree reaches back 1 generation to 1993. 294 later devices descend from it.

Decided: Dec 27, 1999
Review: 280 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K922543 (1993). 294 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
This deviceK990959 K-Centrum Anterior Spinal Fixation SystemSpineology, Inc. · 1999
Descendant · cites it directly · 293 of its ownK011556 Macs Hma Anterior Spinal Stabilization SystemAesculap, Inc. · 2001
Descendant · cites it directly · 250 of its ownK032059 Modification to Macs Modular Anterior Construct SystemAesculap, Inc. · 2003
Descendant · 2 generations on · 248 of its ownK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
Descendant · 3 generations on · 218 of its ownK102249 Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010
Descendant · 3 generations on · 203 of its ownK111571 Viper SystemsJohnson & Johnson · 2011

Showing 5 of 294 descendants. See all descendants

Descendants cleared per year

2001high 38 (2025) · low 0 (2002)2026

Most influential descendants

Showing 5 of 294 · See all

K011556Macs Hma Anterior Spinal Stabilization SystemAesculap, Inc. · 2001 · cites it directly293descendants
K032059Modification to Macs Modular Anterior Construct SystemAesculap, Inc. · 2003 · cites it directly250descendants
K070387Expedium Spine SystemDepuy Spine, Inc. · 2007 · 2 generations on248descendants
K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010 · 3 generations on218descendants
K111571Viper SystemsJohnson & Johnson · 2011 · 3 generations on203descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922543	Z-Plate Anterior Fixation System	Sofamor Danek Mfg., Inc.	1993	—
0 (this device)	K990959	K-Centrum Anterior Spinal Fixation System	Spineology, Inc.	1999	—
+1	K011556	Macs Hma Anterior Spinal Stabilization System	Aesculap, Inc.	2001	—
+1	K032059	Modification to Macs Modular Anterior Construct System	Aesculap, Inc.	2003	—
+2	K070387	Expedium Spine System	Depuy Spine, Inc.	2007	—
+3	K102249	Expedium Spine System	Depuy Spine, A Johnson & Johnson Company	2010	—
+3	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	2	0
2009	1	0
2010	1	0
2011	3	0
2012	6	0
2013	13	0
2014	12	0
2015	13	0
2016	10	0
2017	8	0
2018	17	0
2019	13	0
2020	15	0
2021	12	0
2022	24	0
2023	36	0
2024	36	0
2025	38	0
2026	31	0

FIG. 1 — Lineage of K990959, 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.

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

Get a 510(k) Report

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
*	K922543	Z-Plate Anterior Fixation System Summary page 1 …rthosis FDA Classification: Class II, product code KWQ Pl 4.3 Predicate device Manufacturer \| Device 510(k) Approved Sofamor Danek \| Z-Plate Anterior Fixation System K922543 5/19/93 4.4 Device Description The K-Centrum Anterior Spinal Fixation System is a multi-component system. The construct utilize…	Sofamor Danek Mfg., Inc.	1993	—

Also cleared against K922543: 10 other devices →

What descends from it? (294)

See all 294

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

Number	Device	Applicant	Decided	Descendants
K011556	Macs Hma Anterior Spinal Stabilization System	Aesculap, Inc.	2001	293
K032059	Modification to Macs Modular Anterior Construct System	Aesculap, Inc.	2003	250

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, K011556 (Aesculap, Inc., 2001) has gone furthest, with 293 descendants of its own.
10 other devices also cite its predicate K922543.

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 K-Centrum Anterior Fixator is intended for correction and stabilization of the spine. The K-Centrum is also intended to provide temporary stabilization and augment the development of a solid spinal fusion. The K-Centrum is intended for screw/bolt/fixation attachment to the anterolateral intervertebral bodies from T10 to L5 only and less than 4 motion segments.

The K-Centrum is indicated for degenerative disk disease, disk herniation, spondylosis, spondylolisthesis, burst fracture, failed surgery, corpectomy or vertebrectomy for tumor resection.

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/K990959 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990959: K-Centrum Anterior Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990959

Report an extraction error

Are you the manufacturer?

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