510(k) · Cleared
ClearedModification to Synthes Cervifix System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Mar 6, 2003 after a 29-day review. The FDA summary names no predicate by number. 2 of the 392 devices in its family, counting itself, have a Class I recall. 391 later devices descend from it.
- Decided
- Mar 6, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
391 later devices descend from it, 5 citing it directly. 2 of the 392 devices in this family, counting this one, have a Class I recall.
- This deviceK030377 Modification to Synthes Cervifix SystemSynthes (Usa) · 2003
- Descendant · cites it directly · 378 of its ownK070573 Synapse SystemSynthes Spine Co.Lp · 2007
- Descendant · 2 generations on · 316 of its ownK100634 Synthes Matrix SystemSynthes (Usa) · 2010
- Descendant · 3 generations on · 314 of its ownK100952 Modification to Synthes Matrix SystemSynthes Spine · 2010 · Recalled (Class I)
- Descendant · 4 generations on · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- Descendant · 5 generations on · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
Showing 5 of 391 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 391 · See all- K070573Synapse SystemSynthes Spine Co.Lp · 2007 · cites it directly378descendants
- K100634Synthes Matrix SystemSynthes (Usa) · 2010 · 2 generations on316descendants
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 3 generations on314descendants
- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 4 generations on172descendants
- K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 5 generations on158descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030377 | Modification to Synthes Cervifix System | Synthes (Usa) | 2003 | — |
| +1 | K070573 | Synapse System | Synthes Spine Co.Lp | 2007 | — |
| +2 | K100634 | Synthes Matrix System | Synthes (Usa) | 2010 | — |
| +3 | K100952 | Modification to Synthes Matrix System | Synthes Spine | 2010 | Class I |
| +4 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +5 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 1 |
| 2011 | 3 | 0 |
| 2012 | 12 | 0 |
| 2013 | 8 | 0 |
| 2014 | 18 | 0 |
| 2015 | 24 | 0 |
| 2016 | 16 | 0 |
| 2017 | 26 | 0 |
| 2018 | 23 | 0 |
| 2019 | 19 | 0 |
| 2020 | 24 | 0 |
| 2021 | 21 | 1 |
| 2022 | 27 | 0 |
| 2023 | 43 | 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?
The FDA summary names no predicate by number.
What descends from it? (391)
See all 3915 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K070573 (Synthes Spine Co.Lp, 2007) has gone furthest, with 378 descendants of its own.
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?
The CerviFixO System is indicated for the following: DDD (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 previous cervical spine surgery Tumors When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital…
Read the full statement (209 words)
The CerviFixO System is indicated for the following:
DDD (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 previous cervical spine surgery
Tumors
When used to treat these cervical and occipitocervical conditions, these 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 (Cl-T3) spine.
Rods, Clamps, Screws and Nuts
The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/disIocation or trauma in the upper thoracic spine (TI -T3).
The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in TI-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CewiFixTMSystem can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.O 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030377: Modification to Synthes Cervifix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030377
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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