510(k) · Cleared

Recalled · 2012

Quintex Cervical Plating System

K100243510(k) TraditionalCleared Sep 2, 2010218-day reviewClass II21 CFR 888.3060Recalls 1

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

Aesculap Implant Systems, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Sep 2, 2010 as substantially equivalent to K050813 (Aesculap, Inc., 2005) and 8 other predicates after a 218-day review. Its family tree reaches back 4 generations to 1992. 10 later devices descend from it. It has been recalled once.

Decided: Sep 2, 2010
Review: 218 days
Class: Class II
Product code: KWQ
Recalls: 1
Predicates: 9

Its longest line of descent runs back 4 generations to K922087 (1992). 19 ancestors in all, the oldest K913730 (1992). 10 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
3 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
2 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
1 generation backK040017 Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc. · 2004
This deviceK100243 Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 2010
Descendant · cites it directly · 8 of its ownK141993 Nakoma AcpAlliance Partners, LLC · 2014 · Recalled
Descendant · 2 generations on · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
Descendant · 3 generations on · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
Descendant · 2 generations on · 2 of its ownK173128 Alamo® CAlliance Partners, LLC · 2018
Descendant · 4 generations on · 1 of its ownK250486 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2012high 2 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all

K141993Nakoma AcpAlliance Partners, LLC · 2014 · cites it directly8descendants
K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · 2 generations on3descendants
K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · 3 generations on2descendants
K173128Alamo® CAlliance Partners, LLC · 2018 · 2 generations on2descendants
K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K922087	Anterior Cervical Plate System	Sofamor Danek Mfg., Inc.	1992	—
−3	K990005	Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System	Spinal Concepts, Inc.	1999	1
−2	K000486	Abc Cervical Plating System	Aesculap, Inc.	2000	—
−1	K040017	Abc Caudal and Cranial Extension Plate (E-Plate)	Aesculap, Inc.	2004	—
0 (this device)	K100243	Quintex Cervical Plating System	Aesculap Implant Systems, LLC	2010	—
+1	K141993	Nakoma Acp	Alliance Partners, LLC	2014	1
+2	K231766	Skyway Anterior Cervical Plate System	Kyocera Medical Technologies Inc. (KMTI)	2023	—
+3	K243015	Skyway Anterior Cervical Plate System	Kyocera Medical Technologies, Inc.	2024	—
+2	K173128	Alamo® C	Alliance Partners, LLC	2018	—
+4	K250486	Skyway Anterior Cervical Plate System	Kyocera Medical Technologies Inc. (KMTI)	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1993	1	0
1994	1	0
1995	2	0
1998	3	0
1999	4	0
2002	1	0
2005	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	1	0
2018	1	0
2020	1	0
2021	1	0
2023	1	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K100243, 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? (9)

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
*	K050813	Abc 2 Screw	Aesculap, Inc.	2005	—
*	K040017	Abc Caudal and Cranial Extension Plate (E-Plate) Summary page 1 …NCE Aesculap Implant Systems (AIS), Inc., believes that the Quintex Cervical Plating System is substantially equivalent to the AIS ABC Cervical Plating Systems (KO50813/K040017 /K0O00486/K974706), AlS Caspar Plate & Screw System (K953720/K936269/K913730) and the AIS Spectrum Cervical Spinal System (K02299…	Aesculap, Inc.	2004	—
*	K000486	Abc Cervical Plating System	Aesculap, Inc.	2000	—
*	K974706	Aesculap Abc Cervical Plating System Summary page 1 …ant Systems (AIS), Inc., believes that the Quintex Cervical Plating System is substantially equivalent to the AIS ABC Cervical Plating Systems (KO50813/K040017 /K0O00486/K974706), AlS Caspar Plate & Screw System (K953720/K936269/K913730) and the AIS Spectrum Cervical Spinal System (K022997/K050804). DEVIC…	Aesculap, Inc.	1998	—
*	K953720	Aesculap Caspar Plate & Screw System for Anterior Cervical Fusion Summary page 1 …Quintex Cervical Plating System is substantially equivalent to the AIS ABC Cervical Plating Systems (KO50813/K040017 /K0O00486/K974706), AlS Caspar Plate & Screw System (K953720/K936269/K913730) and the AIS Spectrum Cervical Spinal System (K022997/K050804). DEVICE DESCRIPTION The Aesculap Implant Systems…	Aesculap, Inc.	1995	—
*	K936269	Caspar Titanium Alloy Bone Screws Summary page 1 …Cervical Plating System is substantially equivalent to the AIS ABC Cervical Plating Systems (KO50813/K040017 /K0O00486/K974706), AlS Caspar Plate & Screw System (K953720/K936269/K913730) and the AIS Spectrum Cervical Spinal System (K022997/K050804). DEVICE DESCRIPTION The Aesculap Implant Systems (AIS) Q…	Aesculap, Inc.	1994	—
*	K913730	Aesculap Titanium Bone Plates Summary page 1 …Plating System is substantially equivalent to the AIS ABC Cervical Plating Systems (KO50813/K040017 /K0O00486/K974706), AlS Caspar Plate & Screw System (K953720/K936269/K913730) and the AIS Spectrum Cervical Spinal System (K022997/K050804). DEVICE DESCRIPTION The Aesculap Implant Systems (AIS) Quintex C…	Aesculap, Inc.	1992	—
*	K022997	Spectrum Cervical Spinal System Summary page 1 …ABC Cervical Plating Systems (KO50813/K040017 /K0O00486/K974706), AlS Caspar Plate & Screw System (K953720/K936269/K913730) and the AIS Spectrum Cervical Spinal System (K022997/K050804). DEVICE DESCRIPTION The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-co…	Spinal Innovations, LLC	2002	—
*	K050804	Modification to: Spectrumtm Cervical Spinal System Summary page 1 …vical Plating Systems (KO50813/K040017 /K0O00486/K974706), AlS Caspar Plate & Screw System (K953720/K936269/K913730) and the AIS Spectrum Cervical Spinal System (K022997/K050804). DEVICE DESCRIPTION The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-constraine…	Aesculap, Inc.	2005	—

Also cleared against K050813: 2 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K141993	Nakoma Acp	Alliance Partners, LLC	2014	8
K121801	Quintex Cervical Plating System	Aesculap Implant Systems, LLC	2012	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 24, 2012	Not classified	Z-1455-2012	Nonconforming Material/Component	The firm has received complaints that the locking ring that sits in the head of the screw can come out of the screw head when engaged with the screwdriver if the screwdriver is improperly angled.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
1 of the 19 ancestors has a recall of any class.
Of its descendants, K141993 (Alliance Partners, LLC, 2014) has gone furthest, with 8 descendants of its own.
2 other devices also cite its predicate K050813.

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. 2010, 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 Quintex Cervical Plating System is intended for the immobilization and stabilization of the spine as an adjunct to fusion in patients with: o Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e. fracture or dislocation), Spinal Stenosis, Deformity (i.e., scoliosis, kyphosis, and/or lordosis), Tumors, Pseudoarthrosis as a…

Read the full statement (121 words)

The Quintex Cervical Plating System is intended for the immobilization and stabilization of the spine as an adjunct to fusion in patients with:

o Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),

Spondylolisthesis,

Trauma (i.e. fracture or dislocation),

Spinal Stenosis,

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

Tumors,

Pseudoarthrosis as a result of failed spine surgery,

Failed previous fusions,

Symptomatic cervical spondylosis

Instability following surgery for the above indications.

Levels of anterior cervical intervertebral body screw fixation for this indication are from Co-Th.

Warning: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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/K100243 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100243: Quintex Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100243

Report an extraction error

Are you the manufacturer?

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