510(k) · Cleared
ClearedSynapse System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA Products, LLC · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jan 16, 2014 as substantially equivalent to K091689 (Synthes (Usa), 2009) and 4 other predicates after a 44-day review. Its family tree reaches back 11 generations to 1985. 6 later devices descend from it.
- Decided
- Jan 16, 2014
- Review
- 44 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K853033 (1985). 36 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations between
- 3 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK062934 SierraSeaspine, Inc. · 2006
- 1 generation backK080526 Sierra SystemSeaspine, Inc. · 2008
- This deviceK133698 Synapse SystemSynthes USA Products, LLC · 2014
- Descendant · cites it directly · 5 of its ownK141897 Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC · 2014
- Descendant · 2 generations on · 3 of its ownK142867 Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
- Descendant · 3 generations on · 2 of its ownK213394 Vy Spine™ VySpan™ PCT SystemVy Spine, LLC · 2021
- Descendant · 4 generations on · 1 of its ownK223852 VySpan™ PCT SystemVy Spine, LLC · 2023
- Descendant · 5 generations on · 0 of its ownK232167 VySpan™ PCT SystemVy Spine, LLC · 2023
Show all 11 generations
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK062934 SierraSeaspine, Inc. · 2006
- 1 generation backK080526 Sierra SystemSeaspine, Inc. · 2008
- This deviceK133698 Synapse SystemSynthes USA Products, LLC · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC · 2014 · cites it directly5descendants
- K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015 · 2 generations on3descendants
- K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC · 2021 · 3 generations on2descendants
- K223852VySpan™ PCT SystemVy Spine, LLC · 2023 · 4 generations on1descendant
- K232167VySpan™ PCT SystemVy Spine, LLC · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −10 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −9 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −8 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −7 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −6 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −5 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K062934 | Sierra | Seaspine, Inc. | 2006 | — |
| −1 | K080526 | Sierra System | Seaspine, Inc. | 2008 | — |
| 0 (this device) | K133698 | Synapse System | Synthes USA Products, LLC | 2014 | — |
| +1 | K141897 | Synapse System, Synthes OC Fusion System | Synthes USA Products, LLC | 2014 | — |
| +2 | K142867 | Reliance Posterior Cervical-Thoracic System | Reliance Medical Systems, LLC | 2015 | — |
| +3 | K213394 | Vy Spine™ VySpan™ PCT System | Vy Spine, LLC | 2021 | — |
| +4 | K223852 | VySpan™ PCT System | Vy Spine, LLC | 2023 | — |
| +5 | K232167 | VySpan™ PCT System | Vy Spine, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (5)
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 |
|---|---|---|---|
| * | K091689 | Synapse System 4.0MM, OC Fusion System 4.0MMSummary page 1…Orthopedic MNH; Orthopedic D. Predicate Device Name Trade name: Synthes Synapse System (most recently cleared K091 689) SierraTM System (K062934, K080526)… | 2009 |
| * | K062934 | SierraSummary page 1…MNH; Orthopedic D. Predicate Device Name Trade name: Synthes Synapse System (most recently cleared K091 689) SierraTM System (K062934, K080526) K133698 Page 2 of 4… | 2006 |
| * | K080526 | Sierra SystemSummary page 1…Orthopedic D. Predicate Device Name Trade name: Synthes Synapse System (most recently cleared K091 689) SierraTM System (K062934, K080526) K133698 Page 2 of 4… | 2008 |
| * | K033961 | Altius Oct SystemSummary page 2…80526) K133698 Page 2 of 4 AltiusTM OCT System (K033961, K(043229) E. Device Description The Synapse System is a hook and pedicle screw spinal system which is designed to… | 2004 |
| * | K043229 | Modification to Altius Oct SystemSummary page 2…Page 2 === K133698 Page 2 of 4 AltiusTM OCT System (K033961, K(043229) E. Device Description The Synapse System is a hook and pedicle screw spinal system which is designed to provide… | 2004 |
What descends from it? (6)
2 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 29 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 36 ancestors has a recall of any class.
- Of its descendants, K141897 (Synthes USA Products, LLC, 2014) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K091689.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
These Systems are intended for the following: 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, book 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…
Read the full statement (321 words)
These Systems are intended for the following:
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, book 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133698: 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/K133698
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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