510(k) · Cleared
ClearedModification to S4 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 Mar 14, 2007 as substantially equivalent to K050979 (Aesculap, Inc., 2005) and 1 other predicate after a 216-day review. Its family tree reaches back 10 generations to 1985. 14 later devices descend from it.
- Decided
- Mar 14, 2007
- Review
- 216 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K853033 (1985). 21 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 6 generations between
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- 1 generation backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- This deviceK062327 Modification to S4 Spinal SystemAesculap, Inc. · 2007
- Descendant · cites it directly · 13 of its ownK130887 S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013
- Descendant · 2 generations on · 11 of its ownK181890 Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
- Descendant · 3 generations on · 9 of its ownK192911 Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019
- Descendant · 4 generations on · 8 of its ownK203205 Navigated Spine InstrumentsStryker Spine · 2021
- Descendant · 5 generations on · 7 of its ownK240662 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments…Stryker Leibinger GmbH & Co KG · 2024
Show all 10 generations
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- 1 generation backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- This deviceK062327 Modification to S4 Spinal SystemAesculap, Inc. · 2007
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K130887S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013 · cites it directly13descendants
- K181890Brainlab Compatible K2M Navigation InstrumentsK2m · 2018 · 2 generations on11descendants
- K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019 · 3 generations on9descendants
- K203205Navigated Spine InstrumentsStryker Spine · 2021 · 4 generations on8descendants
- K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG · 2024 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −9 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −8 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −7 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −6 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −5 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −4 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K050979 | S4 Spinal System | Aesculap, Inc. | 2005 | — |
| −1 | K060152 | Modification to S4 Spinal System | Aesculap, Inc. | 2006 | — |
| 0 (this device) | K062327 | Modification to S4 Spinal System | Aesculap, Inc. | 2007 | — |
| +1 | K130887 | S4C Navigation Instruments | Aesculap Implant System, Inc. | 2013 | — |
| +2 | K181890 | Brainlab Compatible K2M Navigation Instruments | K2m | 2018 | — |
| +3 | K192911 | Brainlab Compatible K2M Navigation Instruments | K2m, Inc. | 2019 | — |
| +4 | K203205 | Navigated Spine Instruments | Stryker Spine | 2021 | — |
| +5 | K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q… | Stryker Leibinger GmbH & Co KG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K050979 | S4 Spinal SystemSummary page 1…ifications to the cross connector and the addition of the smooth shank screws are substantially equivalent to the existing components of the Aesculap's S4 Spinal System (K050979/K060152). DEVICE DESCRIPTION The S4 Spinal System consists of 3.5mm rods in 6 lengths, thin and thick lamina hooks, 3.5 and 4.0m… | 2005 |
| * | K060152 | Modification to S4 Spinal SystemSummary page 1…ns to the cross connector and the addition of the smooth shank screws are substantially equivalent to the existing components of the Aesculap's S4 Spinal System (K050979/K060152). DEVICE DESCRIPTION The S4 Spinal System consists of 3.5mm rods in 6 lengths, thin and thick lamina hooks, 3.5 and 4.0mm polyax… | 2006 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130887 | S4C Navigation Instruments | 2013 | 13 |
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 22 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K130887 (Aesculap Implant System, Inc., 2013) has gone furthest, with 13 descendants of its own.
- 11 other devices also cite its predicate K050979.
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 the thoracic spine (Cl -- T3), the S4 Spinal System is intended for the following; * DDD (Neck pain pf discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * Spondylolisthesis * Spinal stenosis * Fracture/dislocation * Failed previous fusion * Tumors The hooks and rods are also intended to provide stabilization to promote fusion following…
Read the full statement (115 words)
When intended to promote fusion of the cervical spine and the thoracic spine (Cl -- T3), the S4 Spinal System is intended for the following;
* DDD (Neck pain pf discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
* Spondylolisthesis
* Spinal stenosis
* Fracture/dislocation
* Failed previous fusion
* Tumors
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 (CI - 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 placed in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062327: Modification to 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/K062327
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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