510(k) · Cleared

Cleared

Indus Anterior Cervical Plate System, Model IM3XXX

K073232510(k) TraditionalCleared Feb 20, 200897-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

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

Cleared on Feb 20, 2008 as substantially equivalent to K030866 (Synthes (Usa), 2003) after a 97-day review. Its family tree reaches back 1 generation to 2003. 17 later devices descend from it.

Decided: Feb 20, 2008
Review: 97 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K030866 (2003). 17 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK030866 Synthes Anterior CSLP SystemSynthes (Usa) · 2003
This deviceK073232 Indus Anterior Cervical Plate System, Model IM3XXXSpinefrontier, Inc. · 2008
Descendant · cites it directly · 16 of its ownK093776 Indus Anterior Cervical Plate SystemSpinefrontier, Inc. · 2010
Descendant · 2 generations on · 15 of its ownK121060 Spine Frontier Indus Acp SystemSpinefrontier, Inc. · 2012 · Recalled
Descendant · 3 generations on · 6 of its ownK153526 Pyrenees Cervical Plate SystemK2m · 2016
Descendant · 3 generations on · 6 of its ownK140234 Aspiron Acp SystemU&I Corp. · 2014
Descendant · 4 generations on · 5 of its ownK162664 Pyrenees Cervical Plate SystemK2m, Inc. · 2016

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2010high 2 (2016) · low 0 (2011)2026

Most influential descendants

Showing 5 of 17 · See all

K093776Indus Anterior Cervical Plate SystemSpinefrontier, Inc. · 2010 · cites it directly16descendants
K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc. · 2012 · 2 generations on15descendants
K153526Pyrenees Cervical Plate SystemK2m · 2016 · 3 generations on6descendants
K140234Aspiron Acp SystemU&I Corp. · 2014 · 3 generations on6descendants
K162664Pyrenees Cervical Plate SystemK2m, Inc. · 2016 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K030866	Synthes Anterior CSLP System	Synthes (Usa)	2003	—
0 (this device)	K073232	Indus Anterior Cervical Plate System, Model IM3XXX	Spinefrontier, Inc.	2008	—
+1	K093776	Indus Anterior Cervical Plate System	Spinefrontier, Inc.	2010	—
+2	K121060	Spine Frontier Indus Acp System	Spinefrontier, Inc.	2012	6
+3	K153526	Pyrenees Cervical Plate System	K2m	2016	—
+3	K140234	Aspiron Acp System	U&I Corp.	2014	—
+4	K162664	Pyrenees Cervical Plate System	K2m, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	1	0
2014	1	0
2016	2	0
2018	2	0
2019	1	0
2022	2	0
2023	2	0
2024	2	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K073232, 2003–2026Source: 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
*	K030866	Synthes Anterior CSLP System Summary page 1 …(21 CFR 888.3060), Class II Product Code: KWQ 3. Predicate Devices K030866 - Synthes Spine - Anterior CSLP System 4. Device Description The INDUS TM Anterior Cervical Plate System c…	Synthes (Usa)	2003	—

Also cleared against K030866: 41 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K093776	Indus Anterior Cervical Plate System	Spinefrontier, Inc.	2010	16

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, K093776 (Spinefrontier, Inc., 2010) has gone furthest, with 16 descendants of its own.
41 other devices also cite its predicate K030866.

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. 2008, this device’s year, is highlighted.

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 INDUSTM Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in whom stability is desired following anterior cervical fusion. The levels of treatment range from C2 to C7. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073232 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073232: Indus Anterior Cervical Plate System, Model IM3XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073232

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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