510(k) Report

510(k) · Cleared

Cleared

Blackstone Ascent Poct System Lateral Offset Adapter

K040034510(k) SpecialCleared Feb 11, 200434-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Blackstone Medical, Inc. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Feb 11, 2004 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 140 devices in its family, counting itself, has a Class I recall. 139 later devices descend from it.

Decided
Feb 11, 2004
Review
34 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

139 later devices descend from it, 3 citing it directly. 1 of the 140 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2008: 3 descendants cleared2016: 3 descendants cleared2012: 2 descendants cleared2017: 6 descendants cleared2011: 2 descendants cleared2013: 1 descendant cleared2019: 8 descendants cleared2020: 10 descendants cleared2021: 8 descendants cleared, 1 with a Class I recall12014: 1 descendant cleared2023: 17 descendants cleared2015: 2 descendants cleared2022: 9 descendants cleared2025: 19 descendants cleared2018: 5 descendants cleared2024: 21 descendants cleared2026: 22 descendants cleared200020052010201520202025
  1. This deviceK040034 Blackstone Ascent Poct System Lateral Offset AdapterBlackstone Medical, Inc. · 2004
  2. Descendant · cites it directly · 129 of its ownK073654 Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc. · 2008
  3. Descendant · cites it directly · 124 of its ownK080394 Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc. · 2008
  4. Descendant · 2 generations on · 97 of its ownK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
  5. Descendant · 3 generations on · 96 of its ownK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
  6. 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

2008: 32011: 22012: 22013: 12014: 12015: 22016: 32017: 62018: 52019: 82020: 102021: 82022: 92023: 172024: 212025: 192026: 22
2008high 22 (2026) · low 0 (2009)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040034Blackstone Ascent Poct System Lateral Offset AdapterBlackstone Medical, Inc.2004—
+1K073654Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc.2008—
+1K080394Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc.2008—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.2013—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.20151
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200830
201120
201220
201310
201410
201520
201630
201760
201850
201980
2020100
202181
202290
2023170
2024210
2025190
2026220
FIG. 1 — Lineage of K040034, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (139)

See all 139

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073654Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc.2008129
K080394Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc.2008124
K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089

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?

  • Of its descendants, K073654 (Blackstone Medical, Inc., 2008) has gone furthest, with 129 descendants of its own.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

More from Blackstone Medical, Inc.

45 FDA decisions under this applicant name. See the company

  • K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2010
  • K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc. · 2010
  • K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 20091 recall
  • K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
  • K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 20083 recalls

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K040034 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040034: Blackstone Ascent Poct System Lateral Offset Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040034

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026