510(k) · Cleared
ClearedSynthes OC Fusion and Synapse Systems
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 Jan 10, 2008 as substantially equivalent to K053418 (Synthes Spine Co.Lp, 2006) and 1 other predicate after a 134-day review. Its family tree reaches back 4 generations to 1985. 2 later devices descend from it.
- Decided
- Jan 10, 2008
- Review
- 134 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K853033 (1985). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 3 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 2 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 1 generation backK053418 Synthes OC Fusion SystemSynthes Spine Co.Lp · 2006
- This deviceK072434 Synthes OC Fusion and Synapse SystemsSynthes Spine Co.Lp · 2008
- Descendant · cites it directly · 1 of its ownK090549 Synthes Synapse TransconnectorSynthes Spine · 2009
- Descendant · 2 generations on · 0 of its ownK181350 ASTRA-OCT Spine SystemSpinecraft, LLC · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −3 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −2 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −1 | K053418 | Synthes OC Fusion System | Synthes Spine Co.Lp | 2006 | — |
| 0 (this device) | K072434 | Synthes OC Fusion and Synapse Systems | Synthes Spine Co.Lp | 2008 | — |
| +1 | K090549 | Synthes Synapse Transconnector | Synthes Spine | 2009 | — |
| +2 | K181350 | ASTRA-OCT Spine System | Spinecraft, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2018 | 1 | 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? (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 |
|---|---|---|---|
| * | K053418 | Synthes OC Fusion SystemSummary page 1…lass II Orthopaedic and Rehabilitation Devices Panel Product Code KWP Predicate Device(s): K053418 Synthes OC Fusion System Device Description: The Synthes OC Fusion System consists of occipital plates,… | 2006 |
| * | K070573 | Synapse SystemSummary page 3…Class II Orthopaedic and Rehabilitation Devices Panel Product Codes MNH, MNI Predicate Device: K070573 Synthes Synapse System Device Description: The Synthes Synapse System consists of cancellous and cortex… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090549 | Synthes Synapse Transconnector | 2009 | 1 |
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 23 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K090549 (Synthes Spine, 2009) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K053418.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The Synthes OC Fusion System is intended to provide stabilization to promote fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse System. Synthes OC Fusion System is indicated for the following: · Degenerative disc disease of the cervical vertebrae (neck pain of…
Read the full statement (438 words)
The Synthes OC Fusion System is intended to provide stabilization to promote fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse System.
Synthes OC Fusion System is indicated for the following:
· Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
* Spondylolisthesis
* Spinal Stenosis
· Fracture/Dislocation
· Atlanto/axial fracture with instability
* Occipital-cervical dislocation
· Revision of previous cervical spinal surgery
a Tumors (primary and metastatic)
The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical spine.
Synthes Synapse System is indicated for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, OC Fusion 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 (C1I-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 (TlI-T3).
The use of these screws (3.5 mm, 4.0mmu and 4.5 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in TI 13 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 rmm/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, or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072434 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072434: Synthes OC Fusion and Synapse Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072434
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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