510(k) · Cleared
ClearedSynapse System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine Co.Lp · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jun 8, 2007 as substantially equivalent to K023675 (Synthes (Usa), 2002) and 1 other predicate after a 100-day review. Its family tree reaches back 1 generation to 2002. 2 of the 381 devices in its family, counting itself, have a Class I recall. 378 later devices descend from it.
- Decided
- Jun 8, 2007
- Review
- 100 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K023675 (2002). 2 ancestors in all. 378 later devices descend from it, 10 citing it directly. 2 of the 381 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK023675 Synthes Cervifix/ AxonSynthes (Usa) · 2002
- This deviceK070573 Synapse SystemSynthes Spine Co.Lp · 2007
- Descendant · cites it directly · 316 of its ownK100634 Synthes Matrix SystemSynthes (Usa) · 2010
- Descendant · 2 generations on · 314 of its ownK100952 Modification to Synthes Matrix SystemSynthes Spine · 2010 · Recalled (Class I)
- Descendant · 3 generations on · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- Descendant · 4 generations on · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- Descendant · 2 generations on · 151 of its ownK111358 Synthes UssSynthes Spine · 2011
Showing 5 of 378 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 378 · See all- K100634Synthes Matrix SystemSynthes (Usa) · 2010 · cites it directly316descendants
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations on314descendants
- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 3 generations on172descendants
- K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 4 generations on158descendants
- K111358Synthes UssSynthes Spine · 2011 · 2 generations on151descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023675 | Synthes Cervifix/ Axon | Synthes (Usa) | 2002 | — |
| 0 (this device) | K070573 | Synapse System | Synthes Spine Co.Lp | 2007 | — |
| +1 | K100634 | Synthes Matrix System | Synthes (Usa) | 2010 | — |
| +2 | K100952 | Modification to Synthes Matrix System | Synthes Spine | 2010 | Class I |
| +3 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +4 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| +2 | K111358 | Synthes Uss | Synthes Spine | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 1 |
| 2011 | 3 | 0 |
| 2012 | 11 | 0 |
| 2013 | 8 | 0 |
| 2014 | 17 | 0 |
| 2015 | 22 | 0 |
| 2016 | 14 | 0 |
| 2017 | 25 | 0 |
| 2018 | 23 | 0 |
| 2019 | 19 | 0 |
| 2020 | 24 | 0 |
| 2021 | 20 | 1 |
| 2022 | 27 | 0 |
| 2023 | 40 | 0 |
| 2024 | 45 | 0 |
| 2025 | 38 | 0 |
| 2026 | 36 | 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.
2 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K023675 | Synthes Cervifix/ AxonSummary page 1…Orthopaedic and Rehabilitation Devices Panel Product Codes MNH, MNI Predicate Device: Synthes CerviFix System - Axon Components - K023675, herein referred to as the Axon System Synthes CerviFix System - K030377 Device Des… | 2002 |
| * | K030377 | Modification to Synthes Cervifix SystemSummary page 1…ce: Synthes CerviFix System - Axon Components - K023675, herein referred to as the Axon System Synthes CerviFix System - K030377 Device Description: The Synthes Synapse System consists of cancellous and cortex polyaxial screws, hooks… | 2003 |
What descends from it? (378)
See all 37810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100634 | Synthes Matrix System | 2010 | 316 |
| K101084 | Caspian Spinal System | 2010 | 62 |
| K090343 | Sentinel Spinal System | 2009 | 21 |
| K171369 | M.U.S.T. MINI Posterior Cervical Screws System | 2017 | 8 |
| K200130 | M.U.S.T. MINI Posterior Cervical Screws System | 2020 | 6 |
| K072434 | Synthes OC Fusion and Synapse Systems | 2008 | 2 |
| K182837 | M.U.S.T. Mini Extension | 2019 | 1 |
| K090549 | Synthes Synapse Transconnector | 2009 | 1 |
| K203149 | M.U.S.T. MINI Posterior Cervical Screws System | 2020 | 0 |
| K132900 | Marauder Cervical-Thoracic Spinal Fixation System | 2013 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
Synthes Synapse System is indicated for the following: Hooks, Plate/Rods, Rods and Screws When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, and Synapse Systems are indicated for the following: * Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by…
Read the full statement (304 words)
Synthes Synapse System is indicated for the following:
Hooks, Plate/Rods, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, and Synapse Systems are indicated for the following:
* Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
* Spondylolisthesis
* Spinal Stenosis
* Fracture/dislocation
Atlantoaxial fracture with instability
* Occipitocervical dislocation
* Revision of pervious cervical spine surgery
Tumor
When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars
The rods, clamps, screws, nuts, variable axis screws, locking screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mm parallel connector.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070573: Synapse System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070573
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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