510(k) · Cleared

Cleared

Codman Slim-Loc System

K013877510(k) SpecialCleared Dec 19, 200126-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

Codman & Shurtleff, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 19, 2001 as substantially equivalent to K953730 (Johnson & Johnson Professionals, Inc., 1995) after a 26-day review. Its family tree reaches back 1 generation to 1995. 257 later devices descend from it.

Decided: Dec 19, 2001
Review: 26 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K953730 (1995). 257 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
This deviceK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
Descendant · cites it directly · 217 of its ownK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
Descendant · 2 generations on · 195 of its ownK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
Descendant · 2 generations on · 193 of its ownK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
Descendant · 3 generations on · 132 of its ownK133475 Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013
Descendant · 4 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014

Showing 5 of 257 descendants. See all descendants

Descendants cleared per year

2004high 33 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 257 · See all

K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004 · cites it directly217descendants
K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007 · 2 generations on195descendants
K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · 2 generations on193descendants
K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC · 2013 · 3 generations on132descendants
K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 4 generations on106descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953730	Codman Anterior Cervical Plate System	Johnson & Johnson Professionals, Inc.	1995	—
0 (this device)	K013877	Codman Slim-Loc System	Codman & Shurtleff, Inc.	2001	—
+1	K040655	Swift Anterior Cervical Plate System	Depuy Spine, Inc.	2004	—
+2	K072546	Swift Plus Anterior Cervical Plate System	Depuy Spine, Inc.	2007	—
+2	K080646	C-Tek Maxan Anterior Cervical Plate System	Biomet Spine	2008	2
+3	K133475	Struxxure Anterior Cervical Plate and Screws	Nexxt Spine, LLC	2013	—
+4	K141376	Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure…	Nexxt Spine, LLC	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	3	0
2007	1	0
2008	4	0
2009	1	0
2010	3	0
2011	6	0
2012	5	0
2013	9	0
2014	8	0
2015	8	0
2016	9	0
2017	6	0
2018	6	0
2019	14	0
2020	20	0
2021	13	0
2022	21	0
2023	28	0
2024	29	0
2025	33	0
2026	29	0

FIG. 1 — Lineage of K013877, 1995–2026Source: 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
*	K953730	Codman Anterior Cervical Plate System Summary page 1 …Materials: Device Description: Performance Data: Appliance, Fixation, Spinal Intervertebral Body CODMAN SLIM-LOC™ System CODMAN Anterior Cervical Plate (ACP) System (K953730) The CODMAN SLIM-LOC™ System is a permanent implant, generally indicated for short-term stabilization of the cervical spine from…	Johnson & Johnson Professionals, Inc.	1995	—

What descends from it? (257)

See all 257

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

Number	Device	Applicant	Decided	Descendants
K040655	Swift Anterior Cervical Plate System	Depuy Spine, Inc.	2004	217
K052552	Hybrid Anterior Cervical Plate System	Depuy Spine, Inc.	2005	39
K102820	Appliance, Fixation, Spinal Intervertebral Body	Alphatec Spine, Inc.	2010	38
K112533	Zavation Cervical Plate System	Zavation, LLC	2011	26
K121658	Orthofix Acp (Anterior Cervical Plate System)	Orthofix, Inc.	2012	4
K162638	CETRA Anterior Cervical Plate System	Orthofix, Inc.	2016	3
K112724	Depuy Pulse Anterior Cerical Plate System	Medos International SARL	2011	2
K191786	Cyclops™ Anterior Cervical Plate System	Degen Medical, Inc.	2019	1
K171439	EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate…	Medos International SARL	2017	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?

Its one ancestor has no recall.
Of its descendants, K040655 (Depuy Spine, Inc., 2004) has gone furthest, with 217 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	—

What is it indicated for?

The CODMAN SLIM-LOC™ System’s plates and screws are permanent implants, generally indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. This product may be employed as an internal fixation device during the time interval required for arthrodesis. Specific clinical indications for anterior plating include: Instability caused by trauma; Instability associated with…

Read the full statement (121 words)

Specific clinical indications for anterior plating include:

Instability caused by trauma;

Instability associated with correction of cervical lordosis and kyphosis deformity;

Instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery;

Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;

Instability associated with single or multiple level corpectomy in advanced degenerative disk disease, spinal canal stenosis, and cervical myelopathy.

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/K013877 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013877: Codman Slim-Loc System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013877

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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