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 System, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 11, 2013 as substantially equivalent to K123352 (Aesculap Implant Systems, Inc., 2012) and 7 other predicates after a 64-day review. Its family tree reaches back 12 generations to 1985. 44 later devices descend from it.
- Decided
- Apr 11, 2013
- Review
- 64 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 12 generations to K853033 (1985). 131 ancestors in all. 44 later devices descend from it, 10 citing it directly.
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations between
- 3 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK081898 Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK123352 S4 Spinal SystemAesculap Implant Systems, Inc. · 2012
- This deviceK130291 S4 Spinal SystemAesculap Implant System, Inc. · 2013
- Descendant · cites it directly · 39 of its ownK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- Descendant · 2 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
- Descendant · 2 generations on · 28 of its ownK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- Descendant · 2 generations on · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- Descendant · 3 generations on · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 3 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK081898 Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK123352 S4 Spinal SystemAesculap Implant Systems, Inc. · 2012
- This deviceK130291 S4 Spinal SystemAesculap Implant System, Inc. · 2013
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018 · cites it directly39descendants
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 2 generations on29descendants
- K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019 · 2 generations on28descendants
- K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · 2 generations on27descendants
- K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −11 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −10 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −9 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −8 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −7 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −6 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −3 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −2 | K081898 | Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −1 | K123352 | S4 Spinal System | Aesculap Implant Systems, Inc. | 2012 | — |
| 0 (this device) | K130291 | S4 Spinal System | Aesculap Implant System, Inc. | 2013 | — |
| +1 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| +2 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
| +2 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
| +2 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| +3 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 10 | 0 |
| 1999 | 13 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 10 | 0 |
| 2003 | 10 | 0 |
| 2004 | 5 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 6 | 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? (8)
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 |
|---|---|---|---|
| * | K123352 | S4 Spinal SystemSummary page 2…ent. SUBSTANTIAL EQUIVALENCE Aesculap® Implant Systems, Inc. believes that the S4 Spinal System is substantially equivalent to rod connectors from the S4 Spinal System (K1 23352/K1 1255 1/K062085) and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, and K081 898). DE… | 2012 |
| * | K112551 | S4 Spinal SystemSummary page 2…STANTIAL EQUIVALENCE Aesculap® Implant Systems, Inc. believes that the S4 Spinal System is substantially equivalent to rod connectors from the S4 Spinal System (K1 23352/K1 1255 1/K062085) and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, and K081 898). DEPARTMENT O… | 2011 |
| * | K062085 | S4 Spinal SystemSummary page 2…QUIVALENCE Aesculap® Implant Systems, Inc. believes that the S4 Spinal System is substantially equivalent to rod connectors from the S4 Spinal System (K1 23352/K1 1255 1/K062085) and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, and K081 898). DEPARTMENT OF HEALTH… | 2007 |
| * | K033901 | Merlin Spine SystemSummary page 2…eves that the S4 Spinal System is substantially equivalent to rod connectors from the S4 Spinal System (K1 23352/K1 1255 1/K062085) and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, and K081 898). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2004 |
| * | K063156 | Modification to Expedium Spine SystemSummary page 2…the S4 Spinal System is substantially equivalent to rod connectors from the S4 Spinal System (K1 23352/K1 1255 1/K062085) and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, and K081 898). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2006 |
| * | K073126 | Expedium Spine SystemSummary page 2…pinal System is substantially equivalent to rod connectors from the S4 Spinal System (K1 23352/K1 1255 1/K062085) and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, and K081 898). DEPARTMENT OF HEALTH & HUMAN SERVICES Public… | 2007 |
| * | K073364 | Expedium 4.5MM Spine SystemSummary page 2…tem is substantially equivalent to rod connectors from the S4 Spinal System (K1 23352/K1 1255 1/K062085) and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, and K081 898). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health S… | 2008 |
| * | K081898 | Expedium Spine SystemSummary page 2…ntially equivalent to rod connectors from the S4 Spinal System (K1 23352/K1 1255 1/K062085) and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, and K081 898). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2008 |
What descends from it? (44)
See all 4410 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182377 | CarboClear® Pedicle Screw System | 2018 | 39 |
| K200519 | CarboClear® II Pedicle Screw System | 2020 | 11 |
| K203317 | CarboClear X Pedicle Screw System | 2020 | 9 |
| K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | 2021 | 8 |
| K232341 | CarboClear® Pedicle Screw System | 2023 | 4 |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | 2024 | 3 |
| K162134 | ENNOVATE Spinal System | 2016 | 2 |
| K233793 | CarboClear® X Pedicle Screw System | 2024 | 1 |
| K243106 | CarboClear® Hybrid Pedicle Screw System | 2024 | 0 |
| K210963 | ENNOVATE Spinal System | 2021 | 0 |
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 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 131 ancestors have a recall of any class.
- Of its descendants, K182377 (CarboFix Orthopedics, Ltd., 2018) has gone furthest, with 39 descendants of its own.
- 5 other devices also cite its predicate K123352.
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 S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-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 with degeneration of the disc confirmed…
Read the full statement (101 words)
The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-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 with 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/K130291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130291: 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/K130291
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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