510(k) · Cleared
ClearedS4 Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jul 27, 2005 as substantially equivalent to K031985 (Spinal Concepts, Inc., 2003) and 5 other predicates after a 99-day review. Its family tree reaches back 8 generations to 1985. 67 later devices descend from it.
- Decided
- Jul 27, 2005
- Review
- 99 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K853033 (1985). 19 ancestors in all. 67 later devices descend from it, 12 citing it directly.
- Root · 8 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 6 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 5 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 4 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 3 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 2 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 1 generation backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- This deviceK050979 S4 Spinal SystemAesculap, Inc. · 2005
- Descendant · cites it directly · 32 of its ownK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- Descendant · cites it directly · 16 of its ownK103414 Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
- Descendant · cites it directly · 15 of its ownK120879 Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · cites it directly · 15 of its ownK110197 Exactech Gibralt Spinal SystemExactech, Inc. · 2011 · Recalled
- Descendant · cites it directly · 14 of its ownK062327 Modification to S4 Spinal SystemAesculap, Inc. · 2007
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K060152Modification to S4 Spinal SystemAesculap, Inc. · 2006 · cites it directly32descendants
- K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011 · cites it directly16descendants
- K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly15descendants
- K110197Exactech Gibralt Spinal SystemExactech, Inc. · 2011 · cites it directly15descendants
- K062327Modification to S4 Spinal SystemAesculap, Inc. · 2007 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −7 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −6 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −5 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −4 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −3 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −2 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −1 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| 0 (this device) | K050979 | S4 Spinal System | Aesculap, Inc. | 2005 | — |
| +1 | K060152 | Modification to S4 Spinal System | Aesculap, Inc. | 2006 | — |
| +1 | K103414 | Venus Cervical Spinal Fixation System | L&K BIOMED Co., Ltd. | 2011 | — |
| +1 | K120879 | Lexus Cervical Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| +1 | K110197 | Exactech Gibralt Spinal System | Exactech, Inc. | 2011 | 1 |
| +1 | K062327 | Modification to S4 Spinal System | Aesculap, Inc. | 2007 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 9 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 8 | 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 MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation SystemSummary page 2…in design to: Aesculap believes that the new S4 Spinal System is substantially equivalent * Nex- Link Spinal System (K031985) • Vertex Spinal System (K042789, 042524) * Summit Spinal System (K013222, K030103, K041203)… | 2003 |
| * | K042789 | Vertex Reconstruction SystemSummary page 2…in design to: Aesculap believes that the new S4 Spinal System is substantially equivalent * Nex- Link Spinal System (K031985) • Vertex Spinal System (K042789, 042524) * Summit Spinal System (K013222, K030103, K041203) S === Page 3 =… | 2004 |
| * | K042524 | Modification to Vertex Reconstruction SystemSummary page 2…design to: Aesculap believes that the new S4 Spinal System is substantially equivalent * Nex- Link Spinal System (K031985) • Vertex Spinal System (K042789, 042524) * Summit Spinal System (K013222, K030103, K041203) S DE… | 2004 |
| * | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemSummary page 2…ew S4 Spinal System is substantially equivalent * Nex- Link Spinal System (K031985) • Vertex Spinal System (K042789, 042524) * Summit Spinal System (K013222, K030103, K041203) S DEPARTMENT OF HEALTH & HUMAN SERVICESPulcH… | 2001 |
| * | K030103 | Summit Oct Spinal System Minipolyaxial ScrewsSummary page 2…nal System is substantially equivalent * Nex- Link Spinal System (K031985) • Vertex Spinal System (K042789, 042524) * Summit Spinal System (K013222, K030103, K041203) S DEPARTMENT OF HEALTH & HUMAN SERVICESPulcHatSeve… | 2003 |
| * | K041203 | Summit Oct Spinal SystemSummary page 2…m is substantially equivalent * Nex- Link Spinal System (K031985) • Vertex Spinal System (K042789, 042524) * Summit Spinal System (K013222, K030103, K041203) S DEPARTMENT OF HEALTH & HUMAN SERVICESPulcHatSeve… | 2004 |
What descends from it? (67)
See all 6712 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060152 | Modification to S4 Spinal System | 2006 | 32 |
| K103414 | Venus Cervical Spinal Fixation System | 2011 | 16 |
| K120879 | Lexus Cervical Fixation System | 2012 | 15 |
| K110197 | Exactech Gibralt Spinal System | 2011 | 15 |
| K062327 | Modification to S4 Spinal System | 2007 | 14 |
| K173180 | Mega Plus Spine System | 2018 | 3 |
| K133214 | Blackbird Spinal System | 2014 | 3 |
| K162300 | Reform® POCT System | 2016 | 2 |
| K160722 | CorticaLINK Spinal Fusion Platform | 2016 | 2 |
| K122163 | Certex Spinal Implant System | 2012 | 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 20 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K060152 (Aesculap, Inc., 2006) has gone furthest, with 32 descendants of its own.
- 9 other devices also cite its predicate K031985.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
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 (Cl - 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/K050979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050979: 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/K050979
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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