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 Dec 12, 2012 as substantially equivalent to K112551 (Aesculap Implant System, Inc., 2011) and 7 other predicates after a 42-day review. Its family tree reaches back 11 generations to 1985. 51 later devices descend from it.
- Decided
- Dec 12, 2012
- Review
- 42 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 11 generations to K853033 (1985). 130 ancestors in all. 51 later devices descend from it, 6 citing it directly.
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations between
- 3 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 1 generation backK081898 Expedium Spine SystemDepuy Spine, Inc. · 2008
- This deviceK123352 S4 Spinal SystemAesculap Implant Systems, Inc. · 2012
- Descendant · cites it directly · 44 of its ownK130291 S4 Spinal SystemAesculap Implant System, Inc. · 2013
- Descendant · 2 generations on · 39 of its ownK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- Descendant · 3 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
- Descendant · 3 generations on · 28 of its ownK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- Descendant · 3 generations on · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
Show all 11 generations
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 1 generation backK081898 Expedium Spine SystemDepuy Spine, Inc. · 2008
- This deviceK123352 S4 Spinal SystemAesculap Implant Systems, Inc. · 2012
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K130291S4 Spinal SystemAesculap Implant System, Inc. · 2013 · cites it directly44descendants
- K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018 · 2 generations on39descendants
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 3 generations on29descendants
- K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019 · 3 generations on28descendants
- K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −10 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −9 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −8 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −7 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −6 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −5 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −2 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −1 | K081898 | Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| 0 (this device) | K123352 | S4 Spinal System | Aesculap Implant Systems, Inc. | 2012 | — |
| +1 | K130291 | S4 Spinal System | Aesculap Implant System, Inc. | 2013 | — |
| +2 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| +3 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
| +3 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
| +3 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 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 |
|---|---|---|---|
| * | K112551 | S4 Spinal SystemSummary page 1…onnectors to the system. SUBSTANTIAL EQUIVALENCE Aesculape Implant Systems, Inc. believes that the S4 Spinal System is substantially equivalent to the S4 Spinal System (K1 12551 /K062085), the Aesculap Spine System Evolution (KO0l 080), and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K0733… | 2011 |
| * | K062085 | S4 Spinal SystemSummary page 1…to the system. SUBSTANTIAL EQUIVALENCE Aesculape Implant Systems, Inc. believes that the S4 Spinal System is substantially equivalent to the S4 Spinal System (K1 12551 /K062085), the Aesculap Spine System Evolution (KO0l 080), and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, K0818… | 2007 |
| * | K001080 | Spine System Evolution | 2000 |
| * | K033901 | Merlin Spine SystemSummary page 1…nal System is substantially equivalent to the S4 Spinal System (K1 12551 /K062085), the Aesculap Spine System Evolution (KO0l 080), and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, K081898). DEVICE DESCRIPTION The S4 Spinal System consists of polyaxial screws and monoaxial screws… | 2004 |
| * | K063156 | Modification to Expedium Spine SystemSummary page 1…m is substantially equivalent to the S4 Spinal System (K1 12551 /K062085), the Aesculap Spine System Evolution (KO0l 080), and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, K081898). DEVICE DESCRIPTION The S4 Spinal System consists of polyaxial screws and monoaxial screws of varyin… | 2006 |
| * | K073126 | Expedium Spine SystemSummary page 1…tantially equivalent to the S4 Spinal System (K1 12551 /K062085), the Aesculap Spine System Evolution (KO0l 080), and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, K081898). DEVICE DESCRIPTION The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diamete… | 2007 |
| * | K073364 | Expedium 4.5MM Spine SystemSummary page 1…equivalent to the S4 Spinal System (K1 12551 /K062085), the Aesculap Spine System Evolution (KO0l 080), and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, K081898). DEVICE DESCRIPTION The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and le… | 2008 |
| * | K081898 | Expedium Spine SystemSummary page 1…nt to the S4 Spinal System (K1 12551 /K062085), the Aesculap Spine System Evolution (KO0l 080), and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, K081898). DEVICE DESCRIPTION The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, va… | 2008 |
What descends from it? (51)
See all 516 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?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 130 ancestors have a recall of any class.
- Of its descendants, K130291 (Aesculap Implant System, Inc., 2013) has gone furthest, with 44 descendants of its own.
- 3 other devices also cite its predicate K112551.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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/antera lateral and posterior, nan-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mnature patients and is intended to be used as ah 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…
Read the full statement (103 words)
The S4 Spinal System is intended for anterior/antera lateral and posterior, nan-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mnature patients and is intended to be used as ah 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) spondytolisthesis,
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/K123352 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123352: S4 Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123352
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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