510(k) · Cleared
ClearedS4 Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 12, 2013 as substantially equivalent to K002824 (Aesculap, Inc., 2001) and 2 other predicates after an 82-day review. Its family tree reaches back 8 generations to 1998. 3 later devices descend from it.
- Decided
- Mar 12, 2013
- Review
- 82 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K980447 (1998). 67 ancestors in all, the oldest K933881 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
- 7 generations backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
- 6 generations backK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
- 5 generations backK030241 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003
- 4 generations backK080407 Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · Recalled
- 3 generations backK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · Recalled
- 2 generations backK082797 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
- 1 generation backK100623 Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · Recalled
- This deviceK123939 S4 Spinal SystemAesculap Implant Systems, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK162134 ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK180433 Ennovate®Aesculap Implant Systems, LLC · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK210963 ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K980447 | Depuy Motech Moss Miami Spinal System | DePuy Orthopaedics, Inc. | 1998 | — |
| −7 | K013558 | Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw | Blackstone Medical, Inc. | 2002 | — |
| −6 | K022399 | Blackstone Spinal Fixation System Spacer | Blackstone Medical, Inc. | 2002 | — |
| −5 | K030241 | Modification to Blackstone Spinal Fixation System | Blackstone Medical, Inc. | 2003 | — |
| −4 | K080407 | Blackstone SFS Parallel Rod Connectors | Blackstone Medical, Inc. | 2008 | 1 |
| −3 | K081684 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | 3 |
| −2 | K082797 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | — |
| −1 | K100623 | Aesculap Implant Systems S4 Spinal System | Aesculap Implant Systems | 2010 | 1 |
| 0 (this device) | K123939 | S4 Spinal System | Aesculap Implant Systems, Inc. | 2013 | — |
| +1 | K162134 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | 2016 | — |
| +2 | K180433 | Ennovate® | Aesculap Implant Systems, LLC | 2018 | 1 |
| +3 | K210963 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K002824 | Macs Modular Anterior Construct SystemSummary page 1…C., be lieves that the new components of the S4 Spinal System are substantially equivalent in design to the components that are previously cleared in the MACS TL System (K002824) and the S4 Spinal Systems (K032219/K 100623). DEVICE DESCRIPTION The S4 Spinal System consists of polyaxial screws and monoaxia… | 2001 |
| * | K032219 | Revolution Spinal Fixation SystemSummary page 1…s of the S4 Spinal System are substantially equivalent in design to the components that are previously cleared in the MACS TL System (K002824) and the S4 Spinal Systems (K032219/K 100623). DEVICE DESCRIPTION The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and le… | 2003 |
| * | K100623 | Aesculap Implant Systems S4 Spinal SystemSummary page 1…S4 Spinal System are substantially equivalent in design to the components that are previously cleared in the MACS TL System (K002824) and the S4 Spinal Systems (K032219/K 100623). DEVICE DESCRIPTION The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, st… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162134 | ENNOVATE Spinal System | 2016 | 2 |
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?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 67 ancestors have a recall of any class.
- Of its descendants, K162134 (Aesculap Implant Systems, LLC, 2016) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K002824.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 54 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and ion-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1 ) degenerative disc disease (defined as discogenic back pain wit degeneration of the disc confirmed…
Read the full statement (102 words)
The 54 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle
and ion-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be
used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of
the following acute and chronic instabilities or deformities:
1 ) degenerative disc disease (defined as discogenic back pain wit
degeneration of the disc confirmed by history and radiographic studies)
2) spondylolisthesis,
3) trauma (i.e., fracture or dislocation),
4) spinal stenosis,
5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6) tumor,
7) pseudoarthrosis, and
8) failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123939: S4 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/K123939
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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