510(k) Report

510(k) · Cleared

Cleared

Blackstone Spinal Fixation System

K994217510(k) TraditionalCleared Feb 28, 200075-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. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Feb 28, 2000 after a 75-day review. The FDA summary names its predicate without a number. 313 later devices descend from it.

Decided
Feb 28, 2000
Review
75 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

313 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2002: 3 descendants cleared2004: 2 descendants cleared2003: 5 descendants cleared2008: 3 descendants cleared2014: 6 descendants cleared2012: 5 descendants cleared2016: 13 descendants cleared2007: 1 descendant cleared2017: 23 descendants cleared2010: 5 descendants cleared2015: 9 descendants cleared2021: 16 descendants cleared2013: 9 descendants cleared2009: 1 descendant cleared2019: 17 descendants cleared2020: 23 descendants cleared2011: 2 descendants cleared2024: 34 descendants cleared2018: 16 descendants cleared2023: 36 descendants cleared2025: 35 descendants cleared2022: 23 descendants cleared2026: 26 descendants cleared200020052010201520202025
  1. This deviceK994217 Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2000
  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 ownK023498 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2002
  4. Descendant · cites it directly · 300 of its ownK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
  5. Descendant · cites it directly · 298 of its ownK030581 Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc. · 2003
  6. Descendant · cites it directly · 297 of its ownK030862 Blackstone Spinal Fixation System Rigid Cross ConnectorBlackstone Medical, Inc. · 2003

Showing 5 of 313 descendants. See all descendants

Descendants cleared per year

2002: 32003: 52004: 22007: 12008: 32009: 12010: 52011: 22012: 52013: 92014: 62015: 92016: 132017: 232018: 162019: 172020: 232021: 162022: 232023: 362024: 342025: 352026: 26
2002high 36 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 313 · See all
  • K022605Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc. · 2002 · cites it directly302descendants
  • K023498Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2002 · cites it directly300descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K994217Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2000—
+1K022605Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc.2002—
+1K023498Modification to Blackstone Spinal Fixation SystemBlackstone 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200350
200420
200710
200830
200910
201050
201120
201250
201390
201460
201590
2016130
2017230
2018160
2019170
2020230
2021160
2022230
2023360
2024340
2025350
2026260
FIG. 1 — Lineage of K994217, 2000–2026Source: 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), 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 MNH? 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? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—DePuy Moss Miami Spinal System
Named without a submission number
—
*—Moss Miami Spinal System — 6.0 System
Named without a submission number
—

What descends from it? (313)

See all 313

10 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
K023498Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2002300
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
K042143Excella-M Spinal SystemInnovasis, Inc.20046
K042514Modification to Blackstone Modular Pedicle Screw SystemBlackstone Medical, Inc.20041

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 MNH devices

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

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients: Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; Who are receiving fusion using autogenous bone graft only; Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and Who are having the device removed after the…

Read the full statement (206 words)

Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;

Who are receiving fusion using autogenous bone graft only;

Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and

Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw System in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

Degenerative spondylolisthesis with objective evidence of neurologic impairment;

Fracture;

Dislocation;

Scoliosis;

Kyphosis;

Spinal tumor; and

Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications:

Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);

Spinal stenosis;

Spondylolisthesis;

Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);

Pseudarthrosis;

Tumor;

Trauma (i.e., fracture or dislocation);

Previous failed fusion.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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 MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K994217 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994217: Blackstone Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994217

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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