510(k) · Cleared
ClearedBlackstone Ascent Multiaxial Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Feb 14, 2008 as substantially equivalent to K030197 (Blackstone Medical, Inc., 2003) and 6 other predicates after a 71-day review. Its family tree reaches back 12 generations to 2001. 9 later devices descend from it.
- Decided
- Feb 14, 2008
- Review
- 71 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K003155 (2001). 84 ancestors in all, the oldest K841189 (1984). 9 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations between
- 3 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 2 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 1 generation backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- This deviceK073420 Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK161032 neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK191932 Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019
- Descendant · 3 generations on · 1 of its ownK231809 Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone…Ulrich Medical USA · 2023
- Descendant · cites it directly · 1 of its ownK113346 Neon SystemUlrich GmbH & Co. KG · 2012
- Descendant · 3 generations on · 0 of its ownK251719 Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations backK012254 VBROsteotech, Inc. · 2001
- 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 7 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 3 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 2 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 1 generation backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- This deviceK073420 Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc. · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG · 2016 · cites it directly7descendants
- K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019 · 2 generations on2descendants
- K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA · 2023 · 3 generations on1descendant
- K113346Neon SystemUlrich GmbH & Co. KG · 2012 · cites it directly1descendant
- K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −11 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −10 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −7 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −2 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −1 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| 0 (this device) | K073420 | Blackstone Ascent Multiaxial Screws | Blackstone Medical, Inc. | 2008 | — |
| +1 | K161032 | neon3™ universal OCT spinal stabilization | Ulrich GmbH & Co. KG | 2016 | 1 |
| +2 | K191932 | Momentum™ Posterior Spinal Fixation System | Ulrich Medical USA | 2019 | — |
| +3 | K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement… | Ulrich Medical USA | 2023 | — |
| +1 | K113346 | Neon System | Ulrich GmbH & Co. KG | 2012 | — |
| +3 | K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 21 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K030197 | Blackstone Posterior Cervical SystemSummary page 1…oduct Code: KWP - 888.3050 - Spinal Interlaminal Fixation Orthosis Substantially Equivalent Devices: BlackstoneTM Posterior Cervical System (K030197 SE 6-12-03) BlackstoneTM Ascent POCT System Lateral Offset Adaptors (K040034 SE 2-11-04) Blackstone… | 2003 |
| * | K040034 | Blackstone Ascent Poct System Lateral Offset AdapterSummary page 1…y Equivalent Devices: BlackstoneTM Posterior Cervical System (K030197 SE 6-12-03) BlackstoneTM Ascent POCT System Lateral Offset Adaptors (K040034 SE 2-11-04) BlackstoneTM Ascent POCT System Hooks (K033980 SE 3-3-04) BlackstoneTM Ascent POCT Syst… | 2004 |
| * | K033980 | Blackstone Ascent Poct System Hooks (System Modification)Summary page 1…em (K030197 SE 6-12-03) BlackstoneTM Ascent POCT System Lateral Offset Adaptors (K040034 SE 2-11-04) BlackstoneTM Ascent POCT System Hooks (K033980 SE 3-3-04) BlackstoneTM Ascent POCT System 5.5mm/3.0mm Single Axial Connector (K042100 SE 9-20-04)… | 2004 |
| * | K042100 | Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial ConnectorSummary page 1…BlackstoneTM Ascent POCT System Hooks (K033980 SE 3-3-04) BlackstoneTM Ascent POCT System 5.5mm/3.0mm Single Axial Connector (K042100 SE 9-20-04) DePuy Spine Summit and Mountaineer OCT Spinal Systems (K042508 SE 10-7-04) Stryker Spin… | 2004 |
| * | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal SystemSummary page 1…ckstoneTM Ascent POCT System 5.5mm/3.0mm Single Axial Connector (K042100 SE 9-20-04) DePuy Spine Summit and Mountaineer OCT Spinal Systems (K042508 SE 10-7-04) Stryker Spine Oasys System (K062853 SE 10-24-06) Medtronic Sofamor Danek Vertex Reconst… | 2004 |
| * | K062853 | Modification to Stryker Spine Oasys SystemSummary page 1…(K042100 SE 9-20-04) DePuy Spine Summit and Mountaineer OCT Spinal Systems (K042508 SE 10-7-04) Stryker Spine Oasys System (K062853 SE 10-24-06) Medtronic Sofamor Danek Vertex Reconstruction System (K070742 SE 9-14-07) Device Description… | 2006 |
| * | K070742 | Modification to Vertex Reconstruction SystemSummary page 1…Spinal Systems (K042508 SE 10-7-04) Stryker Spine Oasys System (K062853 SE 10-24-06) Medtronic Sofamor Danek Vertex Reconstruction System (K070742 SE 9-14-07) Device Description: Description: The Blackstone Ascent POCT System is a temporary, titanium alloy,… | 2007 |
What descends from it? (9)
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 7 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- 5 of the 84 ancestors have a recall of any class.
- Of its descendants, K161032 (Ulrich GmbH & Co. KG, 2016) has gone furthest, with 7 descendants of its own.
- 11 other devices also cite its predicate K030197.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone Ascent POCT System is indicated for: a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; b) spondylolisthesis; c) fracture/dislocation; d) spinal stenosis; e) atlanto-axial fracture with instability; f) occipito-cervical…
Read the full statement (187 words)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone Ascent POCT System is indicated for:
a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
b) spondylolisthesis;
c) fracture/dislocation;
d) spinal stenosis;
e) atlanto-axial fracture with instability;
f) occipito-cervical dislocation;
g) tumors;
h) revision of previous cervical spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (TI-T3). The hooks are intended to be placed from CI to T3. The Songer Cable (titanium) System to be used with the Blackstone Ascent Posterior Occipital Cervical Thoracic System allows for wire/cable attachment to the posterior cervical spine.
The Blackstone Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial Connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073420 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073420: Blackstone Ascent Multiaxial Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073420
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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