510(k) · Cleared

Recalled · 2010

Hallmarktm Anterior Cervical Plate System

K050892510(k) SpecialCleared May 11, 200533-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

Blackstone Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on May 11, 2005 as substantially equivalent to K030595 (Blackstone Medical, Inc., 2003) and 1 other predicate after a 33-day review. Its family tree reaches back 5 generations to 1992. 52 later devices descend from it. It has been recalled 2 times.

Decided: May 11, 2005
Review: 33 days
Class: Class II
Product code: KWQ
Recalls: 2
Predicates: 2

Its longest line of descent runs back 5 generations to K922087 (1992). 15 ancestors in all. 52 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 5 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
4 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
3 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
2 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
1 generation backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
This deviceK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005
Descendant · cites it directly · 51 of its ownK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
Descendant · cites it directly · 19 of its ownK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
Descendant · 2 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
Descendant · 3 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
Descendant · 2 generations on · 15 of its ownK173521 SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2010high 9 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 52 · See all

K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc. · 2010 · cites it directly51descendants
K142060Transom Anterior Cervical PlateNeurostructures, Inc. · 2014 · cites it directly19descendants
K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 2 generations on18descendants
K190016Lateral Plate SystemCorelink, LLC · 2019 · 3 generations on15descendants
K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018 · 2 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K922087	Anterior Cervical Plate System	Sofamor Danek Mfg., Inc.	1992	—
−4	K990005	Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System	Spinal Concepts, Inc.	1999	1
−3	K000486	Abc Cervical Plating System	Aesculap, Inc.	2000	—
−2	K012184	Blackstone Iii Anterior Cervical Plating System	Blackstone Medical, Inc.	2002	—
−1	K030595	Blackstone Fusion Anterior Cervical Plating System	Blackstone Medical, Inc.	2003	—
0 (this device)	K050892	Hallmarktm Anterior Cervical Plate System	Blackstone Medical, Inc.	2005	—
+1	K100614	Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates	Blackstone Medical, Inc.	2010	—
+1	K142060	Transom Anterior Cervical Plate	Neurostructures, Inc.	2014	—
+2	K163104	Terrace™ Anterior Cervical Plate System	Corelink, LLC	2017	—
+3	K190016	Lateral Plate System	Corelink, LLC	2019	—
+2	K173521	SeaSpine Cabo ACP (Anterior Cervical Plate) System	SeaSpine Orthopedics Corporation	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0
1997	1	0
1998	3	0
1999	3	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	2	0
2013	1	0
2014	2	0
2015	1	0
2016	1	0
2017	2	0
2018	1	0
2019	3	0
2020	4	0
2021	3	0
2022	4	0
2023	4	0
2024	6	0
2025	9	0
2026	8	0

FIG. 1 — Lineage of K050892, 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K030595	Blackstone Fusion Anterior Cervical Plating System Summary page 1 …KWQ - 888.3060 - Spinal Intervertebral Body Fixation Orthosis Substantially Equivalent Devices: Blackstone TM Fusion Anterior Cervical Plate System (K030595) BlackstoneTM II0 Anterior Cervical Plating System (K012184) Device Description: The HallmarkTM…	Blackstone Medical, Inc.	2003	—
*	K012184	Blackstone Iii Anterior Cervical Plating System Summary page 1 …ivalent Devices: Blackstone TM Fusion Anterior Cervical Plate System (K030595) BlackstoneTM II0 Anterior Cervical Plating System (K012184) Device Description: The HallmarkTM Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, tita…	Blackstone Medical, Inc.	2002	—

Also cleared against K030595: 4 other devices →

What descends from it? (52)

See all 52

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

Number	Device	Applicant	Decided	Descendants
K100614	Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates	Blackstone Medical, Inc.	2010	51
K142060	Transom Anterior Cervical Plate	Neurostructures, Inc.	2014	19
K121658	Orthofix Acp (Anterior Cervical Plate System)	Orthofix, Inc.	2012	4
K130825	Azure Anterior Cervical Plate System	Orthofix, Inc.	2013	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 15, 2010	Not classified	Z-1653-2010	Nonconforming Material/Component	The Hallmark Anterior Cervical Plate Bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured.
May 8, 2006	Not classified	Z-0478-2008	Device Design	Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
2 of the 15 ancestors have a recall of any class.
Of its descendants, K100614 (Blackstone Medical, Inc., 2010) has gone furthest, with 51 descendants of its own.
4 other devices also cite its predicate K030595.

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 HallmarkTM Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);

b) Spondylolisthesis;

c) Fracture;

d) Spinal stenosis;

e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis)

f) Tumor;

g) Pseudoarthrosis;

h) Revision of previous surgery

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050892 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050892: Hallmarktm 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/K050892

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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