510(k) · Cleared
ClearedBlackstone Ascent Poct System 5.5MM/3.0MM Single Axial Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Sep 20, 2004 as substantially equivalent to K030197 (Blackstone Medical, Inc., 2003) after a 47-day review. Its family tree reaches back 5 generations to 1985. 1 of the 150 devices in its family, counting itself, has a Class I recall. 139 later devices descend from it.
- Decided
- Sep 20, 2004
- Review
- 47 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K853033 (1985). 10 ancestors in all. 139 later devices descend from it, 3 citing it directly. 1 of the 150 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 4 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 3 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 2 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 1 generation backK030197 Blackstone Posterior Cervical SystemBlackstone Medical, Inc. · 2003 · Recalled
- This deviceK042100 Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial ConnectorBlackstone Medical, Inc. · 2004
- Descendant · cites it directly · 129 of its ownK073654 Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc. · 2008
- Descendant · cites it directly · 124 of its ownK080394 Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc. · 2008
- Descendant · 2 generations on · 97 of its ownK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- Descendant · 3 generations on · 96 of its ownK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 78 of its ownK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
Showing 5 of 139 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 139 · See all- K073654Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc. · 2008 · cites it directly129descendants
- K080394Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc. · 2008 · cites it directly124descendants
- K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013 · 2 generations on97descendants
- K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · 3 generations on96descendants
- K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. · 2016 · 4 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −4 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −3 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −2 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −1 | K030197 | Blackstone Posterior Cervical System | Blackstone Medical, Inc. | 2003 | 1 |
| 0 (this device) | K042100 | Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial Connector | Blackstone Medical, Inc. | 2004 | — |
| +1 | K073654 | Blackstone Ascent Poct System Parallel Rod Connector | Blackstone Medical, Inc. | 2008 | — |
| +1 | K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System | Blackstone Medical, Inc. | 2008 | — |
| +2 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
| +3 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 1 |
| +4 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 10 | 0 |
| 2021 | 8 | 1 |
| 2022 | 9 | 0 |
| 2023 | 17 | 0 |
| 2024 | 21 | 0 |
| 2025 | 19 | 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? (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 |
|---|---|---|---|
| * | K030197 | Blackstone Posterior Cervical SystemSummary page 1…al System KWP - 888.3050 - Spinal Interlaminal Fixation Orthosis Substantially Equivalent Devices: BlackstoneTM Ascent POCT System (K030197) Device Description: The BlackstoneTM Ascent POCT System is a titanium alloy, multiple component system comprised of a variety… | 2003 |
What descends from it? (139)
See all 1393 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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K073654 (Blackstone Medical, Inc., 2008) has gone furthest, with 129 descendants of its own.
- 11 other devices also cite its predicate K030197.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 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 T M Ascent POCT System is indicated for: a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) b) spondylolisthesis c) spinal stenosis d) fracture/dislocation e) atlanto/axial fracture with instability f) occipitocervical dislocation g)…
Read the full statement (157 words)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone T M Ascent POCT System is indicated for:
a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
b) spondylolisthesis
c) spinal stenosis
d) fracture/dislocation
e) atlanto/axial fracture with instability
f) occipitocervical dislocation
g) revision of previous cervical spine surgery
h) tumors
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 -3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System to be used with the Blackstone POCT 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/K042100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042100: Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042100
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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