510(k) · Cleared

Cleared

Xia Spine System

K002858510(k) SpecialCleared Oct 13, 200030-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 Oct 13, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 750 devices in its family, counting itself, has a Class I recall. 749 later devices descend from it.

Decided: Oct 13, 2000
Review: 30 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 0

749 later devices descend from it, 6 citing it directly. 1 of the 750 devices in this family, counting this one, has a Class I recall.

This deviceK002858 Xia Spine SystemHowmedica Osteonics Corp. · 2000
Descendant · cites it directly · 742 of its ownK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
Descendant · 2 generations on · 735 of its ownK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
Descendant · 3 generations on · 734 of its ownK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
Descendant · 4 generations on · 710 of its ownK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
Descendant · 5 generations on · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008

Showing 5 of 749 descendants. See all descendants

Descendants cleared per year

2005high 69 (2023) · low 4 (2005)2026

Class I recalls in this family

K211616 ExcelsiusHub8 generations on · 2021

Most influential descendants

Showing 5 of 749 · See all

K050461Xia 4.5 Spinal SystemStryker Spine · 2005 · cites it directly742descendants
K052761Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005 · 2 generations on735descendants
K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · 3 generations on734descendants
K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006 · 4 generations on710descendants
K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · 5 generations on518descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002858	Xia Spine System	Howmedica Osteonics Corp.	2000	—
+1	K050461	Xia 4.5 Spinal System	Stryker Spine	2005	—
+2	K052761	Modification to: Xia 4.5 Spinal System	Stryker Spine	2005	—
+3	K060361	Xia Spinal System, Xia 4.5 Spinal System	Stryker Spine	2006	1
+4	K060979	Xia Titanium and 4.5 Spinal Systems	Stryker Spine	2006	—
+5	K082942	Modfication to: Expedium Spine System	Depuy Spine, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	4	0
2006	7	0
2007	10	0
2008	7	0
2009	12	0
2010	11	0
2011	12	0
2012	29	0
2013	31	0
2014	28	0
2015	37	0
2016	35	0
2017	54	0
2018	51	0
2019	46	0
2020	46	0
2021	36	1
2022	45	0
2023	69	0
2024	64	0
2025	60	0
2026	55	0

FIG. 1 — Lineage of K002858, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (749)

See all 749

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

Number	Device	Applicant	Decided	Descendants
K050461	Xia 4.5 Spinal System	Stryker Spine	2005	742
K043473	Modification to Xia Spinal System	Stryker Spine	2005	289
K061854	Xia Titanium Spinal System and Xia Stainless Steel Spinal System	Stryker Spine	2006	216
K061813	Mantis Spinal System	Stryker Spine	2006	135
K073151	Mantis Spinal System	Stryker Corp.	2007	111
K102235	Mantis Spinal System & Mantis Redux Spinal System	Stryker Spine	2010	109

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

No FDA recall names this device.

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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K050461 (Stryker Spine, 2005) has gone furthest, with 742 descendants of its own.

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	—

https://510kreport.com/device/K002858 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002858: Xia Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002858

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026