510(k) · Cleared
ClearedBlackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System
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 Mar 13, 2008 as substantially equivalent to K030197 (Blackstone Medical, Inc., 2003) and 4 other predicates after a 29-day review. Its family tree reaches back 10 generations to 1985. 1 of the 145 devices in its family, counting itself, has a Class I recall. 124 later devices descend from it.
- Decided
- Mar 13, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K853033 (1985). 20 ancestors in all. 124 later devices descend from it, 3 citing it directly. 1 of the 145 devices in this family, counting this one, has a Class I recall.
- 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 deviceK080394 Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc. · 2008
- Descendant · cites it directly · 97 of its ownK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- Descendant · 2 generations on · 96 of its ownK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 78 of its ownK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- Descendant · 2 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
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 deviceK080394 Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc. · 2008
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 124 · See all- K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013 · cites it directly97descendants
- K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · 2 generations on96descendants
- K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. · 2016 · 3 generations on78descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 2 generations on69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 3 generations on42descendants
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) | K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System | Blackstone Medical, Inc. | 2008 | — |
| +1 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
| +2 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 1 |
| +3 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| +2 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +3 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 8 | 1 |
| 2022 | 8 | 0 |
| 2023 | 14 | 0 |
| 2024 | 21 | 0 |
| 2025 | 18 | 0 |
| 2026 | 22 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K030197 | Blackstone Posterior Cervical SystemSummary page 1…sification Product Code: KWP - 888.3050 - Spinal Interlaminal Fixation Orthosis Substantially Equivalent Devices: BlackstoneTM Posterior Cervical System (K030 197 SE 6-12-03) BlackstoneTm Ascent POCT System Lateral Offset Adaptors (K040034 SE 2-11-04) BlackstoneTm Ascent… | 2003 |
| * | K040034 | Blackstone Ascent Poct System Lateral Offset AdapterSummary page 1…stantially Equivalent Devices: BlackstoneTM Posterior Cervical System (K030 197 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… | 2004 |
| * | K033980 | Blackstone Ascent Poct System Hooks (System Modification)Summary page 1…ical System (K030 197 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.Omm Single Axial Connector (K0421 00 SE 9-20-04)… | 2004 |
| * | K042100 | Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial ConnectorSummary page 1…4 SE 2-11-04) BlackstoneTm Ascent POCT System Hooks (K033980 SE 3-3-04) BlackstoneTm Ascent POCT System 5.5mm/3.Omm Single Axial Connector (K0421 00 SE 9-20-04) BlackstoneTm Ascent POCT System Parallel Rod Connectors (K073654 SE 1-24-08) Device Description: Descript… | 2004 |
| * | K073654 | Blackstone Ascent Poct System Parallel Rod ConnectorSummary page 1…BlackstoneTm Ascent POCT System 5.5mm/3.Omm Single Axial Connector (K0421 00 SE 9-20-04) BlackstoneTm Ascent POCT System Parallel Rod Connectors (K073654 SE 1-24-08) Device Description: Description: The Blackstone Ascent POCT System is a temporary, titanium alloy, multiple compone… | 2008 |
What descends from it? (124)
See all 1243 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K123783 (Globus Medical, Inc., 2013) has gone furthest, with 97 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 (189 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 (Tl-T3). The hooks are intended to be placed from C1 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 or ParallelRod Connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080394: Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080394
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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