510(k) Report

510(k) · Cleared

Cleared

Blackstone Spinal Fixation System, Second-Generation Cross-Connector

K003735510(k) TraditionalCleared May 8, 2001155-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 May 8, 2001 after a 155-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 306 later devices descend from it.

Decided
May 8, 2001
Review
155 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

306 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2003: 5 descendants cleared2002: 2 descendants cleared2008: 3 descendants cleared2007: 1 descendant cleared2004: 1 descendant cleared2017: 23 descendants cleared2010: 4 descendants cleared2015: 9 descendants cleared2021: 16 descendants cleared2014: 5 descendants cleared2013: 9 descendants cleared2009: 1 descendant cleared2012: 5 descendants cleared2019: 17 descendants cleared2020: 23 descendants cleared2011: 2 descendants cleared2016: 12 descendants cleared2024: 33 descendants cleared2018: 16 descendants cleared2023: 36 descendants cleared2025: 34 descendants cleared2022: 23 descendants cleared2026: 26 descendants cleared200020052010201520202025
  1. This deviceK003735 Blackstone Spinal Fixation System, Second-Generation Cross-ConnectorBlackstone Medical, Inc. · 2001
  2. Descendant · cites it directly · 302 of its ownK022605 Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc. · 2002
  3. Descendant · cites it directly · 300 of its ownK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
  4. Descendant · cites it directly · 298 of its ownK030581 Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc. · 2003
  5. Descendant · cites it directly · 297 of its ownK030862 Blackstone Spinal Fixation System Rigid Cross ConnectorBlackstone Medical, Inc. · 2003
  6. Descendant · cites it directly · 297 of its ownK030241 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003

Showing 5 of 306 descendants. See all descendants

Descendants cleared per year

2002: 22003: 52004: 12007: 12008: 32009: 12010: 42011: 22012: 52013: 92014: 52015: 92016: 122017: 232018: 162019: 172020: 232021: 162022: 232023: 362024: 332025: 342026: 26
2002high 36 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 306 · See all
  • K022605Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc. · 2002 · cites it directly302descendants
  • K022399Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002 · cites it directly300descendants
  • K030581Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc. · 2003 · cites it directly298descendants
  • K030862Blackstone Spinal Fixation System Rigid Cross ConnectorBlackstone Medical, Inc. · 2003 · cites it directly297descendants
  • K030241Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003 · cites it directly297descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003735Blackstone Spinal Fixation System, Second-Generation Cross-ConnectorBlackstone Medical, Inc.2001—
+1K022605Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc.2002—
+1K022399Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc.2002—
+1K030581Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc.2003—
+1K030862Blackstone Spinal Fixation System Rigid Cross ConnectorBlackstone Medical, Inc.2003—
+1K030241Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200350
200410
200710
200830
200910
201040
201120
201250
201390
201450
201590
2016120
2017230
2018160
2019170
2020230
2021160
2022230
2023360
2024330
2025340
2026260
FIG. 1 — Lineage of K003735, 2001–2026Source: 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.

Planning a device in MNI? 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
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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? (306)

See all 306

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

NumberDeviceApplicantDecidedDescendants
K022605Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc.2002302
K022399Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc.2002300
K030581Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc.2003298
K030862Blackstone Spinal Fixation System Rigid Cross ConnectorBlackstone Medical, Inc.2003297
K030241Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2003297
K080407Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc.2008296
K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc.2008277
K070460Allez Spine Cross ConnectorsAllez Spine, LLC20070

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?

  • Of its descendants, K022605 (Blackstone Medical, Inc., 2002) has gone furthest, with 302 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/K003735 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003735: Blackstone Spinal Fixation System, Second-Generation Cross-Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003735

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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