510(k) · Cleared
ClearedS4 Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 2, 2007 as substantially equivalent to K032219 (Spinal Innovations, Inc., 2003) after a 224-day review. Its family tree reaches back 1 generation to 2003. 95 later devices descend from it.
- Decided
- Mar 2, 2007
- Review
- 224 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032219 (2003). 95 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK032219 Revolution Spinal Fixation SystemSpinal Innovations, Inc. · 2003
- This deviceK062085 S4 Spinal SystemAesculap · 2007
- Descendant · cites it directly · 94 of its ownK090657 Modification to: S4 Spinal SystemAesculap Implant Systems · 2009
- Descendant · cites it directly · 92 of its ownK100623 Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · Recalled
- Descendant · cites it directly · 61 of its ownK112551 S4 Spinal SystemAesculap Implant System, Inc. · 2011
- Descendant · cites it directly · 51 of its ownK123352 S4 Spinal SystemAesculap Implant Systems, Inc. · 2012
- Descendant · cites it directly · 44 of its ownK130291 S4 Spinal SystemAesculap Implant System, Inc. · 2013
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 95 · See all- K090657Modification to: S4 Spinal SystemAesculap Implant Systems · 2009 · cites it directly94descendants
- K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · cites it directly92descendants
- K112551S4 Spinal SystemAesculap Implant System, Inc. · 2011 · cites it directly61descendants
- K123352S4 Spinal SystemAesculap Implant Systems, Inc. · 2012 · cites it directly51descendants
- K130291S4 Spinal SystemAesculap Implant System, Inc. · 2013 · cites it directly44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032219 | Revolution Spinal Fixation System | Spinal Innovations, Inc. | 2003 | — |
| 0 (this device) | K062085 | S4 Spinal System | Aesculap | 2007 | — |
| +1 | K090657 | Modification to: S4 Spinal System | Aesculap Implant Systems | 2009 | — |
| +1 | K100623 | Aesculap Implant Systems S4 Spinal System | Aesculap Implant Systems | 2010 | 1 |
| +1 | K112551 | S4 Spinal System | Aesculap Implant System, Inc. | 2011 | — |
| +1 | K123352 | S4 Spinal System | Aesculap Implant Systems, Inc. | 2012 | — |
| +1 | K130291 | S4 Spinal System | Aesculap Implant System, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 14 | 0 |
| 2024 | 12 | 0 |
| 2025 | 10 | 0 |
| 2026 | 6 | 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? (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 | Decided |
|---|---|---|---|
| * | K032219 | Revolution Spinal Fixation SystemSummary page 1…Orthopedics SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the modified S4 Spinal System is substantially equivalent to our S4 Spinal System (K032219). DEVICE DESCRIPTION The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, va… | 2003 |
What descends from it? (95)
See all 957 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
The S4 Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 join; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spin; and d) who are having the device removed after the development of a solid fusion mass may not go above the L5-S1 joint, the levels of pedicle screw…
Read the full statement (290 words)
The S4 Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 join; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spin; and d) who are having the device removed after the development of a solid fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.
The S4 Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spin: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the S4 Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture of dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the S4 Spinal System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior throracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062085 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062085: S4 Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062085
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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