510(k) · Cleared

Cleared

S4 Cervical Occipital Plate Spinal System

K100147510(k) SpecialCleared Jul 23, 2010185-day reviewClass II21 CFR 888.3070

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

Aesculap Implant System, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jul 23, 2010 as substantially equivalent to K062012 (Aesculap, Inc., 2007) after a 185-day review. Its family tree reaches back 1 generation to 2007. 24 later devices descend from it.

Decided: Jul 23, 2010
Review: 185 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K062012 (2007). 24 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK062012 S4 Cervical Occipital Plate Spinal SystemAesculap, Inc. · 2007 · Recalled
This deviceK100147 S4 Cervical Occipital Plate Spinal SystemAesculap Implant System, Inc. · 2010
Descendant · cites it directly · 17 of its ownK121725 Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012
Descendant · 2 generations on · 8 of its ownK171369 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017
Descendant · 3 generations on · 6 of its ownK200130 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020
Descendant · cites it directly · 5 of its ownK112905 Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · Recalled
Descendant · 4 generations on · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2012high 6 (2020) · low 0 (2021)2026

Most influential descendants

Showing 5 of 24 · See all

K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012 · cites it directly17descendants
K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017 · 2 generations on8descendants
K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020 · 3 generations on6descendants
K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · cites it directly5descendants
K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 4 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K062012	S4 Cervical Occipital Plate Spinal System	Aesculap, Inc.	2007	6
0 (this device)	K100147	S4 Cervical Occipital Plate Spinal System	Aesculap Implant System, Inc.	2010	—
+1	K121725	Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System	Pioneer Surgical Technology, Inc.	2012	—
+2	K171369	M.U.S.T. MINI Posterior Cervical Screws System	Medacta International S.A.	2017	—
+3	K200130	M.U.S.T. MINI Posterior Cervical Screws System	Medacta International S.A.	2020	—
+1	K112905	Compress (R) Segmental Humeral Replacement System	Biomet Orthopedics, LLC	2012	2
+4	K200936	Invictus™ CT Spinal Fixation System	Alphatec Spine, Inc.	2020	—

Descendants by year cleared

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

FIG. 1 — Lineage of K100147, 2007–2026Source: 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 NKB? 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 NKB device

#1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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? (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
*	K062012	S4 Cervical Occipital Plate Spinal System Summary page 1 …® Implant System (AIS), LLC. believes that the modifications made to the 54 Cervical Occipital Plating Spinal System is substantially equivalent to our predicate system (K062012). ,DEVICE DESCRI.PTION The AIS® S4 Cervical Occipital Plate Spinal System is an implant system used to facilitate the biological…	Aesculap, Inc.	2007	6

Also cleared against K062012: 1 other device →

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K121725	Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System	Pioneer Surgical Technology, Inc.	2012	17
K112905	Compress (R) Segmental Humeral Replacement System	Biomet Orthopedics, LLC	2012	5

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 a recall.
Of its descendants, K121725 (Pioneer Surgical Technology, Inc., 2012) has gone furthest, with 17 descendants of its own.
1 other device also cites its predicate K062012.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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	38	87	4	34
2008	36	59	5	82
2009	44	71	33	171
2010	37	111	4	462
2011	48	84	3	577
2012	60	79	13	1,747
2013	35	73	0	1,962
2014	46	90	3 (1)	1,671
2015	55	90	3	1,446
2016	50	84	1	1,585
2017	63	69	1	1,618
2018	56	61	3	1,684
2019	39	84	1	1,915
2020	48	68	1	2,076
2021	32	61	0	1,745
2022	34	88	5	1,339
2023	44	72	2	919
2024	39	57	3	1,614
2025	24	61	1	1,171
2026	30	91	3	—

What is it indicated for?

When intended to promote fusion of the cervical spine and thoracic spine (C1 -T3) and occipito-cervico-thoracic junction (occiput-T3) and are intended 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 * Failed previous fusion * Atlanto/axial fracture with instability * Occipitocervical dislocation *…

Read the full statement (136 words)

When intended to promote fusion of the cervical spine and thoracic spine (C1 -T3)

and occipito-cervico-thoracic junction (occiput-T3) and are intended 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

* Failed previous fusion

* Atlanto/axial fracture with instability

* Occipitocervical dislocation

* Revision of previous cervical spine surgery

* Tumors

The occipital bone screws are limited to occipital fixation only. The hooks and rods are also

intended to provide stabilization to promote fusion following reduction of fracture/dislocation

or trauma in the cervical/upper thoracic (C1 -T3) spine.

The use of the polyaxial screws is limited to placement in T1-T3 in treating thoracic

conditions only. Screws are not intended to be place in the cervical spine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100147 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100147: S4 Cervical Occipital Plate Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100147

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