510(k) Report

510(k) · Cleared

Cleared

Blackstone Spinal Fixation System Staple & Washer

K022605510(k) SpecialCleared Aug 21, 200215-day reviewClass II21 CFR 888.3060

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

Blackstone Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Aug 21, 2002 as substantially equivalent to K994217 (Blackstone Medical, Inc., 2000) and 3 other predicates after a 15-day review. Its family tree reaches back 2 generations to 1998. 302 later devices descend from it.

Decided
Aug 21, 2002
Review
15 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K980447 (1998). 6 ancestors in all. 302 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor2003: 4 descendants cleared2008: 3 descendants cleared2004: 1 descendant cleared2017: 23 descendants cleared2010: 4 descendants cleared2015: 9 descendants cleared2021: 16 descendants cleared2014: 5 descendants cleared2012: 5 descendants cleared2013: 9 descendants cleared2009: 1 descendant cleared2016: 12 descendants cleared2018: 16 descendants cleared2020: 23 descendants cleared2023: 36 descendants cleared2019: 17 descendants cleared2025: 34 descendants cleared2011: 2 descendants cleared2024: 33 descendants cleared2022: 23 descendants cleared2026: 26 descendants clearedK980447 · Depuy Motech Moss Miami Spinal System · DePuy Orthopaedics, Inc. · 1998K013558 · Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw · Blackstone Medical, Inc. · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 9 descendants3 generations forward: 22 descendants4 generations forward: 45 descendants5 generations forward: 59 descendants6 generations forward: 45 descendants7 generations forward: 41 descendants8 generations forward: 27 descendants9 generations forward: 8 descendants10 generations forward: 10 descendants11 generations forward: 16 descendants12 generations forward: 14 descendants13 generations forward: 1 descendant K013558 · Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw · Blackstone Medical, Inc. · 2002K980447 · Depuy Motech Moss Miami Spinal System · DePuy Orthopaedics, Inc. · 19980+5+10
  1. Root · 2 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
  2. 1 generation backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
  3. This deviceK022605 Blackstone Spinal Fixation System Staple & WasherBlackstone 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 ownK030241 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003
  6. Descendant · cites it directly · 296 of its ownK080407 Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · Recalled
  7. Descendant · 2 generations on · 277 of its ownK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · Recalled
  8. Descendant · 3 generations on · 209 of its ownK082797 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008

Showing 5 of 302 descendants. See all descendants

Descendants cleared per year

2003: 42004: 12008: 32009: 12010: 42011: 22012: 52013: 92014: 52015: 92016: 122017: 232018: 162019: 172020: 232021: 162022: 232023: 362024: 332025: 342026: 26
2003high 36 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 302 · See all
  • K030581Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc. · 2003 · cites it directly298descendants
  • K030241Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003 · cites it directly297descendants
  • K080407Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · cites it directly296descendants
  • K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · 2 generations on277descendants
  • K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · 3 generations on209descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K980447Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc.1998—
−1K013558Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc.2002—
0 (this device)K022605Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc.2002—
+1K030581Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc.2003—
+1K030241Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2003—
+1K080407Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc.20081
+2K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc.20083
+3K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200340
200410
200830
200910
201040
201120
201250
201390
201450
201590
2016120
2017230
2018160
2019170
2020230
2021160
2022230
2023360
2024330
2025340
2026260
FIG. 1 — Lineage of K022605, 1998–2026Source: 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 KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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What was it cleared against? (4)

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
*K994217Blackstone Spinal Fixation System
Summary page 1
…KWQ 888.3060 - Spinal Intervertebral Body Fixation & Classification: Orthosis Substantially Equivalent Devices: BlackstoneTMSpinal Fixation System (K9942 17) BlackstoneTM Spinal Fixation System Second-Gen Cross- Connector (K003735)…
Blackstone Medical, Inc.2000—
*K003735Blackstone Spinal Fixation System, Second-Generation Cross-Connector
Summary page 1
…quivalent Devices: BlackstoneTMSpinal Fixation System (K9942 17) BlackstoneTM Spinal Fixation System Second-Gen Cross- Connector (K003735) BlackstoneTM Spinal Fixation System 4.5mm Mono-Axial Screws (K013558)…
Blackstone Medical, Inc.2001—
*K013558Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw
Summary page 1
…ion System Second-Gen Cross- Connector (K003735) BlackstoneTM Spinal Fixation System 4.5mm Mono-Axial Screws (K013558) BlackstoneTMSpinal Fixation System 4.5mm Multi-Axial Screws 6020674) Device Description…
Blackstone Medical, Inc.2002—
*K020674Blackstone Spinal Fixation System 4.5MM Multi-Axial Screw
Summary page 3
…ross-Connector (K003735) BlackstoneTM Spinal Fixation System 4.5mm Mono-Axial Screws (KO13558) Blackstonem Spinal Fixation System 4.5mm Multi-Axial Screws (K020674) 510(k) Number: Device Name: BlackstoneTMSpinalFixation System 3…
Blackstone Medical, Inc.2002—

Also cleared against K994217: 9 other devices →

What descends from it? (302)

See all 302

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

NumberDeviceApplicantDecidedDescendants
K030581Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc.2003298
K030241Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2003297
K080407Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc.2008296
K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc.20030
K030667Encore Anterior Spinal Staple SystemEncore Medical L.P.20030

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?

  • The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K030581 (Blackstone Medical, Inc., 2003) has gone furthest, with 298 descendants of its own.
  • 9 other devices also cite its predicate K994217.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

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 anterolateral screwhtaple fixation of the T6-L5 spine, is intended for the following indications:

a) Degenerative disc disease (ddd) - this should be defined. Based on the 5/23/96 Panel meeting, ddd should be defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

b) Spondylolisthesis

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

d) Spinal stenosis;

e) Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

Q Tumor

g) Pseudarthrosis

h) Previous failed fusion.

Indications for use as stated in the FDA summary.

Also cleared against K994217

9 other devices cite the same predicate.

  • K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 20083 recalls
  • K080407Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 20081 recall
  • K042143Excella-M Spinal SystemInnovasis, Inc. · 2004
  • K042514Modification to Blackstone Modular Pedicle Screw SystemBlackstone Medical, Inc. · 20042 recalls
  • K030581Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc. · 2003
  • K030862Blackstone Spinal Fixation System Rigid Cross ConnectorBlackstone Medical, Inc. · 2003

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

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The KWQ category page

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https://510kreport.com/device/K022605 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022605: Blackstone Spinal Fixation System Staple & Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022605

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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