510(k) · Cleared
ClearedVySpan™ PCT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vy Spine, LLC · NKG Posterior Cervical Screw System
Cleared on Sep 27, 2023 as substantially equivalent to K223852 (Vy Spine, LLC, 2023) after a 68-day review. Its family tree reaches back 16 generations to 1985.
- Decided
- Sep 27, 2023
- Review
- 68 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K853033 (1985). 49 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations between
- 3 generations backK142867 Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
- 2 generations backK213394 Vy Spine™ VySpan™ PCT SystemVy Spine, LLC · 2021
- 1 generation backK223852 VySpan™ PCT SystemVy Spine, LLC · 2023
- This deviceK232167 VySpan™ PCT SystemVy Spine, LLC · 2023
Show all 16 generations
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 14 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 13 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 12 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 11 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 10 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 9 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK062934 SierraSeaspine, Inc. · 2006
- 6 generations backK080526 Sierra SystemSeaspine, Inc. · 2008
- 5 generations backK133698 Synapse SystemSynthes USA Products, LLC · 2014
- 4 generations backK141897 Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC · 2014
- 3 generations backK142867 Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
- 2 generations backK213394 Vy Spine™ VySpan™ PCT SystemVy Spine, LLC · 2021
- 1 generation backK223852 VySpan™ PCT SystemVy Spine, LLC · 2023
- This deviceK232167 VySpan™ PCT SystemVy Spine, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −15 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −14 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −13 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −12 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −11 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −10 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −9 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K062934 | Sierra | Seaspine, Inc. | 2006 | — |
| −6 | K080526 | Sierra System | Seaspine, Inc. | 2008 | — |
| −5 | K133698 | Synapse System | Synthes USA Products, LLC | 2014 | — |
| −4 | K141897 | Synapse System, Synthes OC Fusion System | Synthes USA Products, LLC | 2014 | — |
| −3 | K142867 | Reliance Posterior Cervical-Thoracic System | Reliance Medical Systems, LLC | 2015 | — |
| −2 | K213394 | Vy Spine™ VySpan™ PCT System | Vy Spine, LLC | 2021 | — |
| −1 | K223852 | VySpan™ PCT System | Vy Spine, LLC | 2023 | — |
| 0 (this device) | 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 |
| 2003 | 1 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 NKG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K223852 | VySpan™ PCT SystemSummary page 4…ct Code: NKG, KWP Substantial Equivalence The VySpan™ PCT System is substantially equivalent to the primary predicate VySpan™ PCT System (K223852) in terms of material, intended use, levels of attachment, size range, and strength. Device Description The VySpan™ PCT System i… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 49 ancestors have a recall of any class.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The VySpan™ PCT System, which is used to promote fusion of the cervical spine and the cervicothoracic (C1-T3), and 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 • Revision of previous cervical spine surgery • Tumors The use of the mini polyaxial screws is limited to placement in the…
Read the full statement (143 words)
The VySpan™ PCT System, which is used to promote fusion of the cervical spine and the cervicothoracic (C1-T3), and 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
• Revision of previous cervical spine surgery
• Tumors
The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
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.
The VySpan™ PCT System can also be linked to the VyLink™ Screw System using the dual diameter rods and rod-to-rod connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232167: VySpan™ PCT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232167
Report an extraction error
Are you the manufacturer?
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