510(k) · Cleared

Recalled · 2005

SC-Acufix Thinline Anterior Cervical Plate System

K013979510(k) SpecialCleared Feb 13, 200272-day reviewClass II21 CFR 888.3060Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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

Cleared on Feb 13, 2002 as substantially equivalent to K990005 (Spinal Concepts, Inc., 1999) after a 72-day review. Its family tree reaches back 2 generations to 1992. 21 later devices descend from it. It has been recalled 2 times.

Decided: Feb 13, 2002
Review: 72 days
Class: Class II
Product code: KWQ
Recalls: 2
Predicates: 1

Its longest line of descent runs back 2 generations to K922087 (1992). 5 ancestors in all. 21 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
1 generation backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
This deviceK013979 SC-Acufix Thinline Anterior Cervical Plate SystemSpinal Concepts, Inc. · 2002
Descendant · cites it directly · 19 of its ownK024326 Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate SystemSpinal Concepts, Inc. · 2003 · Recalled
Descendant · 2 generations on · 17 of its ownK052072 The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level…Abbott Spine, Inc. · 2005
Descendant · cites it directly · 16 of its ownK143626 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic…Zimmer Spine, Inc. · 2015
Descendant · 2 generations on · 13 of its ownK192481 AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020
Descendant · 3 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2003high 7 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 21 · See all

K024326Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate SystemSpinal Concepts, Inc. · 2003 · cites it directly19descendants
K052072The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level PlatesAbbott Spine, Inc. · 2005 · 2 generations on17descendants
K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc. · 2015 · cites it directly16descendants
K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020 · 2 generations on13descendants
K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 3 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K922087	Anterior Cervical Plate System	Sofamor Danek Mfg., Inc.	1992	—
−1	K990005	Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System	Spinal Concepts, Inc.	1999	1
0 (this device)	K013979	SC-Acufix Thinline Anterior Cervical Plate System	Spinal Concepts, Inc.	2002	—
+1	K024326	Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System	Spinal Concepts, Inc.	2003	4
+2	K052072	The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level Plates	Abbott Spine, Inc.	2005	—
+1	K143626	inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical…	Zimmer Spine, Inc.	2015	—
+2	K192481	AccelFix Lumbar Plate System	L&K BIOMED Co., Ltd.	2020	—
+3	K210035	ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System…	Aegis Spine	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2008	1	0
2015	1	0
2019	1	0
2020	1	0
2021	2	0
2022	2	0
2023	7	0
2024	2	0
2026	2	0

FIG. 1 — Lineage of K013979, 1992–2026Source: 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
*	K990005	Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System Summary page 1 …inal Fixation System PROPRIETARY NAME SC-AcuFix Thinline Anterior Cervical Plate System PREDICATE DEVICE SCI Anterior Cervical Plate System, later trademarked SC-AcuFix (K990005). This is a design modification per established design control procedures. DEVICE DESCRIPTION The SC-AcuFix Thinline Anterior Ce…	Spinal Concepts, Inc.	1999	1

Also cleared against K990005: 4 other devices →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K024326	Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System	Spinal Concepts, Inc.	2003	19
K143626	inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…	Zimmer Spine, Inc.	2015	16
K181190	Pinehurst Anterior Cervical Plate System	Signature Orthopaedics Pty, Ltd.	2019	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 14, 2005	Not classified	Z-0292-06	Other	Modification to labeling for surgical implant.
Jul 1, 2002	Not classified	Z-0880-05	Other	Complaints were recieved where swivels came out of plate and where the screw went through the plate.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K024326 (Spinal Concepts, Inc., 2003) has gone furthest, with 19 descendants of its own.
4 other devices also cite its predicate K990005.

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 SC-AcuFix Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

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/K013979 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013979: SC-Acufix Thinline Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013979

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026