510(k) · Cleared
ClearedSynapse System 4.0MM, OC Fusion System 4.0MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jul 10, 2009 after a 30-day review. The FDA summary names no predicate by number. 42 later devices descend from it.
- Decided
- Jul 10, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
42 later devices descend from it, 6 citing it directly.
- This deviceK091689 Synapse System 4.0MM, OC Fusion System 4.0MMSynthes (Usa) · 2009
- Descendant · cites it directly · 27 of its ownK133556 Virage Oct Spinal Fixation SystemZimmer Spine, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 13 of its ownK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 13 of its ownK150918 PASS OCT Spinal SystemMedicrea International SA · 2015
- Descendant · cites it directly · 6 of its ownK133698 Synapse SystemSynthes USA Products, LLC · 2014
- Descendant · 2 generations on · 5 of its ownK182182 YUKON OCT Spinal SystemK2m · 2018
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc. · 2014 · cites it directly27descendants
- K171444YUKON OCT Spinal SystemK2m, Inc. · 2017 · 2 generations on13descendants
- K150918PASS OCT Spinal SystemMedicrea International SA · 2015 · 2 generations on13descendants
- K133698Synapse SystemSynthes USA Products, LLC · 2014 · cites it directly6descendants
- K182182YUKON OCT Spinal SystemK2m · 2018 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091689 | Synapse System 4.0MM, OC Fusion System 4.0MM | Synthes (Usa) | 2009 | — |
| +1 | K133556 | Virage Oct Spinal Fixation System | Zimmer Spine, Inc. | 2014 | 2 |
| +2 | K171444 | YUKON OCT Spinal System | K2m, Inc. | 2017 | 3 |
| +2 | K150918 | PASS OCT Spinal System | Medicrea International SA | 2015 | — |
| +1 | K133698 | Synapse System | Synthes USA Products, LLC | 2014 | — |
| +2 | K182182 | YUKON OCT Spinal System | K2m | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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 KWP? 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? (42)
See all 426 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133556 | Virage Oct Spinal Fixation System | 2014 | 27 |
| K133698 | Synapse System | 2014 | 6 |
| K141897 | Synapse System, Synthes OC Fusion System | 2014 | 5 |
| K131833 | Centurion Poct System | 2014 | 2 |
| K132504 | Tiger Occipital-Cervical-Thoracic Spinal Fixation System | 2013 | 2 |
| K142460 | EXPEDIUM Spine System/Synapse System | 2014 | 0 |
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?
- Of its descendants, K133556 (Zimmer Spine, Inc., 2014) has gone furthest, with 27 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Hooks, Plate/Rods, Plates, Rods and Screws When intended to provide stabilization as an adjunct to 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 skeletally mature patients using allograft and/or autograft for the following: *Degenerative Disc Disease (DDD) (defined as neck pain of…
Read the full statement (453 words)
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to provide stabilization as an adjunct to 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 skeletally mature patients using allograft and/or autograft 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 previous 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 and 4.0 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.
The Synthes OC Fusion System is intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) and screws (T1-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 skeletally mature patients using allograft and/or autograft 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
· 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091689: Synapse System 4.0MM, OC Fusion System 4.0MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091689
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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