510(k) · Cleared

Cleared

Casf (TM) (Contoured Anterior Spinal Fixaton Sys.)

K904446510(k) TraditionalCleared Sep 5, 1991342-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

Acromed Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Sep 5, 1991 after a 342-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Sep 5, 1991
Review: 342 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK904446 Casf (TM) (Contoured Anterior Spinal Fixaton Sys.)Acromed Corp. · 1991
Descendant · cites it directly · 1 of its ownK980228 University Plate Anterior SystemAcromed Corp. · 1998
Descendant · 2 generations on · 0 of its ownK192281 AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System…Medos International SARL · 2019

Most influential descendants

Showing 2 of 2 · See all

K980228University Plate Anterior SystemAcromed Corp. · 1998 · cites it directly1descendant
K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL · 2019 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K904446	Casf (TM) (Contoured Anterior Spinal Fixaton Sys.)	Acromed Corp.	1991	—
+1	K980228	University Plate Anterior System	Acromed Corp.	1998	—
+2	K192281	AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior…	Medos International SARL	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2019	1	0

FIG. 1 — Lineage of K904446, 1991–2019Source: 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.

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?

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

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K980228	University Plate Anterior System	Acromed Corp.	1998	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?

Of its descendants, K980228 (Acromed Corp., 1998) has gone furthest, with 1 descendant 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/K904446 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904446: Casf (TM) (Contoured Anterior Spinal Fixaton Sys.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904446

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