510(k) · Cleared
Recalled · Class II · 2020S4 Cervical Occipital Plate Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 9, 2007 after a 207-day review. The FDA summary names its predicate without a number. 27 later devices descend from it. It has been recalled 6 times.
- Decided
- Feb 9, 2007
- Review
- 207 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 6
- Predicates
- 0
27 later devices descend from it, 2 citing it directly.
- This deviceK062012 S4 Cervical Occipital Plate Spinal SystemAesculap, Inc. · 2007
- Descendant · cites it directly · 24 of its ownK100147 S4 Cervical Occipital Plate Spinal SystemAesculap Implant System, Inc. · 2010
- Descendant · 2 generations on · 17 of its ownK121725 Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012
- Descendant · 3 generations on · 8 of its ownK171369 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017
- Descendant · 4 generations on · 6 of its ownK200130 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020
- Descendant · 2 generations on · 5 of its ownK112905 Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K100147S4 Cervical Occipital Plate Spinal SystemAesculap Implant System, Inc. · 2010 · cites it directly24descendants
- K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012 · 2 generations on17descendants
- K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017 · 3 generations on8descendants
- K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020 · 4 generations on6descendants
- K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062012 | S4 Cervical Occipital Plate Spinal System | Aesculap, Inc. | 2007 | — |
| +1 | K100147 | S4 Cervical Occipital Plate Spinal System | Aesculap Implant System, Inc. | 2010 | — |
| +2 | K121725 | Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System | Pioneer Surgical Technology, Inc. | 2012 | — |
| +3 | K171369 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2017 | — |
| +4 | K200130 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2020 | — |
| +2 | K112905 | Compress (R) Segmental Humeral Replacement System | Biomet Orthopedics, LLC | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 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 |
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
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 | Decided |
|---|---|---|---|
| * | — | Summit Occipito-Cervico-Thoracic (OCT) Spinal Systems Named without a submission number | |
| * | — | S4 Cervical Spinal System Named without a submission number |
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 8, 2020 | Class II | Z-1445-2022 | Device Design | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion. |
| Sep 8, 2020 | Class II | Z-1446-2022 | Device Design | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion. |
| Sep 8, 2020 | Class II | Z-1443-2022 | Device Design | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion. |
| Sep 8, 2020 | Class II | Z-1444-2022 | Device Design | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion. |
| Sep 8, 2020 | Class II | Z-1448-2022 | Device Design | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion. |
| Sep 8, 2020 | Class II | Z-1447-2022 | Device Design | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100147 (Aesculap Implant System, Inc., 2010) has gone furthest, with 24 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 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 (Cl-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 (134 words)
When intended to promote fusion of the cervical spine and thoracic spine (Cl-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 (Cl-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/K062012 · printed Nov 3, 2026
Cite this page
510(k) Report. “K062012: S4 Cervical Occipital Plate Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K062012
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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