510(k) · Cleared
ClearedSynthes OC Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine Co.Lp · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Sep 6, 2006 as substantially equivalent to K982322 (Synthes (Usa), 1998) after a 272-day review. Its family tree reaches back 3 generations to 1985. 25 later devices descend from it.
- Decided
- Sep 6, 2006
- Review
- 272 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K853033 (1985). 25 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 2 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 1 generation backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- This deviceK053418 Synthes OC Fusion SystemSynthes Spine Co.Lp · 2006
- Descendant · cites it directly · 21 of its ownK083863 Theken Atoll Oct Spinal SystemTheken Spine, LLC · 2009
- Descendant · 2 generations on · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
- Descendant · 3 generations on · 12 of its ownK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
- Descendant · 4 generations on · 10 of its ownK191575 ARx Spinal SystemLife Spine, Inc. · 2019
- Descendant · 4 generations on · 9 of its ownK200070 ARx Spinal SystemLife Spine, Inc. · 2020
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC · 2009 · cites it directly21descendants
- K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015 · 2 generations on13descendants
- K151196Nautilus Spinal SystemLife Spine, Inc. · 2015 · 3 generations on12descendants
- K191575ARx Spinal SystemLife Spine, Inc. · 2019 · 4 generations on10descendants
- K200070ARx Spinal SystemLife Spine, Inc. · 2020 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −2 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −1 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| 0 (this device) | K053418 | Synthes OC Fusion System | Synthes Spine Co.Lp | 2006 | — |
| +1 | K083863 | Theken Atoll Oct Spinal System | Theken Spine, LLC | 2009 | — |
| +2 | K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine, Inc. | 2015 | — |
| +3 | K151196 | Nautilus Spinal System | Life Spine, Inc. | 2015 | — |
| +4 | K191575 | ARx Spinal System | Life Spine, Inc. | 2019 | — |
| +4 | K200070 | ARx Spinal System | Life Spine, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSummary page 1…hosis Class 1I Orthopaedic and Rehabilitation Devices Panel Product Code KWP Predicate Device(s): K982322 - Synthes Occipital-Cervical Plate/Rod and Hook System, cleared November 25, 1998… | 1998 |
What descends from it? (25)
See all 252 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K083863 (Theken Spine, LLC, 2009) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K982322.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
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 (CI-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon System. Synthes OC Fusion System is indicated for the following: * Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with…
Read the full statement (126 words)
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 (CI-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon 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 spine 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/K053418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053418: Synthes OC Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053418
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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