510(k) · Cleared
ClearedBRIDALVEIL Occipital Cervical Thoracic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astura Medical · NKG Posterior Cervical Screw System
Cleared on Oct 2, 2017 as substantially equivalent to K143471 (Medtronic Sofamor Danek USA, Inc., 2015) and 6 other predicates after a 157-day review. Its family tree reaches back 10 generations to 1985. 1 later device descends from it.
- Decided
- Oct 2, 2017
- Review
- 157 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K853033 (1985). 31 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 6 generations between
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK073654 Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc. · 2008
- This deviceK171250 BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical · 2017
- Descendant · cites it directly · 0 of its ownK220570 M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A. · 2022
Show all 10 generations
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK073654 Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc. · 2008
- This deviceK171250 BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical · 2017
Most influential descendants
Showing 1 of 1 · See all- K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −9 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −8 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −7 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −6 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −5 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −4 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K073654 | Blackstone Ascent Poct System Parallel Rod Connector | Blackstone Medical, Inc. | 2008 | — |
| 0 (this device) | K171250 | BRIDALVEIL Occipital Cervical Thoracic System | Astura Medical | 2017 | — |
| +1 | K220570 | M.U.S.T. MINI Posterior Cervical Screws System Extension | Medacta International S.A. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2015 | 7 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (7)
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 |
|---|---|---|---|
| * | K143471 | VERTEX Reconstruction SystemSummary page 4…KWP CFR Section N/A Device Panel Orthopedic Primary Predicate Device Medtronic VERTEX® Reconstruction System - K143471, K152338 Secondary Predicate NuVasive® VuePoint® OCT System - K150474, K153336 Devices Zimmer Spine… | 2015 |
| * | K152338 | VERTEX (r) Reconstruction SystemSummary page 4…KWP CFR Section N/A Device Panel Orthopedic Primary Predicate Device Medtronic VERTEX® Reconstruction System - K143471, K152338 Secondary Predicate NuVasive® VuePoint® OCT System - K150474, K153336 Devices Zimmer Spine Virage®… | 2015 |
| * | K150474 | NuVasive VuePoint II OCT SystemSummary page 4…Orthopedic Primary Predicate Device Medtronic VERTEX® Reconstruction System - K143471, K152338 Secondary Predicate NuVasive® VuePoint® OCT System - K150474, K153336 Devices Zimmer Spine Virage® OCT Spinal Fixation System - K153631 Ulri… | 2015 |
| * | K153336 | VuePoint OCT SystemSummary page 4…Orthopedic Primary Predicate Device Medtronic VERTEX® Reconstruction System - K143471, K152338 Secondary Predicate NuVasive® VuePoint® OCT System - K150474, K153336 Devices Zimmer Spine Virage® OCT Spinal Fixation System - K153631 Ulrich GmbH n… | 2016 |
| * | K153631 | Zimmer Virage OCT Spinal Fixation SystemSummary page 4…71, K152338 Secondary Predicate NuVasive® VuePoint® OCT System - K150474, K153336 Devices Zimmer Spine Virage® OCT Spinal Fixation System - K153631 Ulrich GmbH neon3™ universal OCT spinal stabilization - K150650 Blackst… | 2016 |
| * | K150650 | neon3Summary page 4…vices Zimmer Spine Virage® OCT Spinal Fixation System - K153631 Ulrich GmbH neon3™ universal OCT spinal stabilization - K150650 Blackstone Ascent POCT System – K073654 Reference Devices Alphatec Spine Solanas™ Posteri… | 2015 |
| * | K073654 | Blackstone Ascent Poct System Parallel Rod ConnectorSummary page 4…ystem - K153631 Ulrich GmbH neon3™ universal OCT spinal stabilization - K150650 Blackstone Ascent POCT System – K073654 Reference Devices Alphatec Spine Solanas™ Posterior Stabilization System - (K052201) Alph… | 2008 |
| † | K052201 | Solanas Posterior Stabilization System | 2005 |
| † | K111076 | Solanas Avalon Posterior Fixation System | 2011 |
| † | K123906 | Vertex Reconstruction System, Vertext Select Reconstruction System | 2013 |
| † | K093319 | Nuvasive Vuepoint Oct System | 2010 |
| † | K070573 | Synapse System | 2007 |
| † | K091689 | Synapse System 4.0MM, OC Fusion System 4.0MM | 2009 |
| † | K141897 | Synapse System, Synthes OC Fusion System | 2014 |
| † | K110353 | Mountaineer Oct Spinal System | 2011 |
| † | K132332 | Mountaineer Oct Spinal System | 2013 |
| † | K142741 | OASYS System | 2015 |
| † | K111719 | Oasys Spinal System | 2012 |
| † | K032394 | Stryker Spine Oasys System | 2004 |
| † | K131833 | Centurion Poct System | 2014 |
| † | K143278 | LnK Posterior Cervical Fixation System | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220570 | M.U.S.T. MINI Posterior Cervical Screws System Extension | 2022 | 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?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 31 ancestors have a recall of any class.
- Of its descendants, K220570 (Medacta International S.A., 2022) has gone furthest, with 0 descendants of its own.
- 18 other devices also cite its predicate K143471.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 BRIDALVEIL Occipital Cervical Thoracic System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical…
Read the full statement (211 words)
The BRIDALVEIL Occipital Cervical Thoracic System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The BRIDALVEIL Occipital Cervical Thoracic System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the BRIDALVEIL Occipital Cervical Thoracic System may be connected to the OLYMPIC Posterior Spinal Fixation System rods and connectors. Transition rods with differing diameters may also be used to connect the BRIDALVEIL Occipital Cervical Thoracic System to the OLYMPIC Posterior Spinal Fixation System. Refer to the OLYMPIC Posterior Spinal Fixation System package insert for instructions for use and indications for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171250: BRIDALVEIL Occipital Cervical Thoracic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171250
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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