510(k) · Cleared

Cleared

Cervive Anterior Cervical Plating System, Model Number 157.XXX Series Catalogue Numbers

K022798510(k) TraditionalCleared Nov 19, 200288-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

Corin USA · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Nov 19, 2002 as substantially equivalent to K945700 (Synthes (Usa), 1995) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1995.

Decided: Nov 19, 2002
Review: 88 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K945700 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK945700 Synthes (Usa) Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1995
This deviceK022798 Cervive Anterior Cervical Plating System, Model Number 157.XXX…Corin USA · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945700	Synthes (Usa) Anterior Cervical Vertebrae Plate System	Synthes (Usa)	1995	—
0 (this device)	K022798	Cervive Anterior Cervical Plating System, Model Number 157.XXX Series…	Corin USA	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K022798, 1995–2002Source: 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? (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
*	K945700	Synthes (Usa) Anterior Cervical Vertebrae Plate System Summary page 2 …ce basis The sponsor claims substantial equivalence (SE) of the Cervive Anterior Cervical Plating System to the previously approved Synthes Cervical Spine Locking Plate (K945700) and Blackstone Anterior Cervical Plate (K974885). Mechanical testing has been carried out in accordance with ASTM 1717-96. Prot…	Synthes (Usa)	1995	—
*	K974885	Blackstone Medical Inc. Anterior Cervical Plate System Summary page 2 …ce (SE) of the Cervive Anterior Cervical Plating System to the previously approved Synthes Cervical Spine Locking Plate (K945700) and Blackstone Anterior Cervical Plate (K974885). Mechanical testing has been carried out in accordance with ASTM 1717-96. Protocols and reports from this testing are provided…	Blackstone Medical, Inc.	1998	—

Also cleared against K945700: 23 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 2 ancestors has a recall.
23 other devices also cite its predicate K945700.

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 Cervive Anterior Cervical Plating System is indicated for use in temporarily stabilizing the cervical spine during the development of solid spinal fusion in patients with degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), primary and metastatic malignant tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, and/or spinal cord stenosis.

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022798 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022798: Cervive Anterior Cervical Plating System, Model Number 157.XXX Series Catalogue Numbers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022798

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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