510(k) · Cleared

Cleared

Synthes Cervifix/ Axon

K023675510(k) SpecialCleared Nov 26, 200225-day reviewClass II21 CFR 888.3050

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

Synthes (Usa) · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Nov 26, 2002 after a 25-day review. The FDA summary names no predicate by number. 2 of the 483 devices in its family, counting itself, have a Class I recall. 482 later devices descend from it.

Decided: Nov 26, 2002
Review: 25 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 0

482 later devices descend from it, 11 citing it directly. 2 of the 483 devices in this family, counting this one, have a Class I recall.

This deviceK023675 Synthes Cervifix/ AxonSynthes (Usa) · 2002
Descendant · cites it directly · 378 of its ownK070573 Synapse SystemSynthes Spine Co.Lp · 2007
Descendant · cites it directly · 316 of its ownK100634 Synthes Matrix SystemSynthes (Usa) · 2010
Descendant · 2 generations on · 314 of its ownK100952 Modification to Synthes Matrix SystemSynthes Spine · 2010 · Recalled (Class I)
Descendant · cites it directly · 180 of its ownK052402 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
Descendant · 2 generations on · 175 of its ownK052734 Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005

Showing 5 of 482 descendants. See all descendants

Descendants cleared per year

2005high 50 (2023) · low 2 (2006)2026

Class I recalls in this family

K100952 Modification to Synthes Matrix System2 generations on · 2010
K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 482 · See all

K070573Synapse SystemSynthes Spine Co.Lp · 2007 · cites it directly378descendants
K100634Synthes Matrix SystemSynthes (Usa) · 2010 · cites it directly316descendants
K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations on314descendants
K052402Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005 · cites it directly180descendants
K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005 · 2 generations on175descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K023675	Synthes Cervifix/ Axon	Synthes (Usa)	2002	—
+1	K070573	Synapse System	Synthes Spine Co.Lp	2007	—
+1	K100634	Synthes Matrix System	Synthes (Usa)	2010	—
+2	K100952	Modification to Synthes Matrix System	Synthes Spine	2010	Class I
+1	K052402	Vertex Reconstruction System	Medtronic Sofamor Danek	2005	—
+2	K052734	Modification to: Vertex Reconstruction System	Medtronic Sofamor Danek	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	3	0
2006	2	0
2007	4	0
2008	5	0
2009	6	0
2010	5	1
2011	10	0
2012	17	0
2013	17	0
2014	26	0
2015	28	0
2016	22	0
2017	29	0
2018	29	0
2019	21	0
2020	29	0
2021	24	1
2022	28	0
2023	50	0
2024	46	0
2025	42	0
2026	39	0

FIG. 1 — Lineage of K023675, 2002–2026Source: 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.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (482)

See all 482

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

Number	Device	Applicant	Decided	Descendants
K070573	Synapse System	Synthes Spine Co.Lp	2007	378
K100634	Synthes Matrix System	Synthes (Usa)	2010	316
K052402	Vertex Reconstruction System	Medtronic Sofamor Danek	2005	180
K050391	Protex CT Cervicothoracic Spinal System	Globus Medical, Inc.	2005	148
K110197	Exactech Gibralt Spinal System	Exactech, Inc.	2011	15
K171369	M.U.S.T. MINI Posterior Cervical Screws System	Medacta International S.A.	2017	8
K200130	M.U.S.T. MINI Posterior Cervical Screws System	Medacta International S.A.	2020	6
K071905	Posterior Cervicothoracic Spinal Fixation System (PCFS)	Lanx, LLC	2007	6
K141897	Synapse System, Synthes OC Fusion System	Synthes USA Products, LLC	2014	5
K133374	Streamline Oct Occipito-Cervico-Thoracic System	Pioneer Surgical Technology, Inc. (Rti Surgical, I	2014	3

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K070573 (Synthes Spine Co.Lp, 2007) has gone furthest, with 378 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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	14	96	2	210
2008	13	50	1	594
2009	12	89	23	682
2010	14	186	2	474
2011	12	67	6	792
2012	18	112	1	918
2013	12	99	3	1,090
2014	13	138	0	1,022
2015	9	113	1	1,348
2016	0	—	3	1,379
2017	0	—	0	864
2018	0	—	1	657
2019	0	—	2	518
2020	0	—	0	796
2021	0	—	0	525
2022	0	—	2	335
2023	0	—	0	332
2024	0	—	0	436
2025	0	—	0	494
2026	0	—	0	—

What is it indicated for?

The CerviFix® System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies Spondylolisthesis Spinal stenosis Fracture/dislocation Atlantoaxial fracture with instability Occipitocervical dislocation Revision of previous cervical spine surgery Tumors When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital…

Read the full statement (208 words)

The CerviFix® System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies

Spondylolisthesis

Spinal stenosis

Fracture/dislocation

Atlantoaxial fracture with instability

Occipitocervical dislocation

Revision of previous cervical spine surgery

Tumors

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws and Nuts

The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system, and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/6.0 mm parallel connector.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023675 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023675: Synthes Cervifix/ Axon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023675

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