510(k) · Cleared

Cleared

Isola Anterior System

K943819510(k) TraditionalCleared Feb 9, 1995188-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 Feb 9, 1995 after a 188-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 84 later devices descend from it.

Decided: Feb 9, 1995
Review: 188 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 0

84 later devices descend from it, 4 citing it directly.

This deviceK943819 Isola Anterior SystemAcromed Corp. · 1995
Descendant · cites it directly · 82 of its ownK971248 Kaneda SR Anterior Spinal SystemAcromed Corp. · 1997
Descendant · 2 generations on · 73 of its ownK100061 Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010
Descendant · 3 generations on · 72 of its ownK131533 Cayman MI Plate SystemK2m, Inc. · 2013
Descendant · 4 generations on · 52 of its ownK172941 CASCADIA Interbody SystemK2m · 2018
Descendant · 5 generations on · 24 of its ownK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018

Showing 5 of 84 descendants. See all descendants

Descendants cleared per year

1997high 14 (2023) · low 0 (1999)2026

Most influential descendants

Showing 5 of 84 · See all

K971248Kaneda SR Anterior Spinal SystemAcromed Corp. · 1997 · cites it directly82descendants
K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010 · 2 generations on73descendants
K131533Cayman MI Plate SystemK2m, Inc. · 2013 · 3 generations on72descendants
K172941CASCADIA Interbody SystemK2m · 2018 · 4 generations on52descendants
K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018 · 5 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K943819	Isola Anterior System	Acromed Corp.	1995	—
+1	K971248	Kaneda SR Anterior Spinal System	Acromed Corp.	1997	—
+2	K100061	Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX	K2m, Inc.	2010	—
+3	K131533	Cayman MI Plate System	K2m, Inc.	2013	—
+4	K172941	CASCADIA Interbody System	K2m	2018	—
+5	K181347	Aries® Lumbar Interbodies	Osseus Fusion Systems, LLC	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
2004	1	0
2008	1	0
2010	1	0
2011	1	0
2012	1	0
2013	1	0
2015	1	0
2016	1	0
2018	3	0
2019	6	0
2020	3	0
2021	4	0
2022	8	0
2023	14	0
2024	11	0
2025	13	0
2026	12	0

FIG. 1 — Lineage of K943819, 1995–2026Source: 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.

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?

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

What descends from it? (84)

See all 84

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

Number	Device	Applicant	Decided	Descendants
K971248	Kaneda SR Anterior Spinal System	Acromed Corp.	1997	82
K980228	University Plate Anterior System	Acromed Corp.	1998	1
K192281	AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…	Medos International SARL	2019	0
K191212	CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…	Medos International SARL	2019	0

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, K971248 (Acromed Corp., 1997) has gone furthest, with 82 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/K943819 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943819: Isola Anterior System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943819

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Record history

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