510(k) · Cleared
ClearedBlackstone Spinal Fixation System Lateral Offset (System Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 26, 2003 as substantially equivalent to K994217 (Blackstone Medical, Inc., 2000) and 7 other predicates after a 122-day review. Its family tree reaches back 3 generations to 1998. 298 later devices descend from it.
- Decided
- Jun 26, 2003
- Review
- 122 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 3 generations to K980447 (1998). 11 ancestors in all. 298 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
- 2 generations backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
- 1 generation backK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
- This deviceK030581 Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc. · 2003
- Descendant · cites it directly · 296 of its ownK080407 Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · Recalled
- Descendant · cites it directly · 277 of its ownK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 209 of its ownK082797 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
- Descendant · 2 generations on · 130 of its ownK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 117 of its ownK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
Showing 5 of 298 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 298 · See all- K080407Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · cites it directly296descendants
- K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · cites it directly277descendants
- K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · 2 generations on209descendants
- K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · 2 generations on130descendants
- K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010 · 2 generations on117descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980447 | Depuy Motech Moss Miami Spinal System | DePuy Orthopaedics, Inc. | 1998 | — |
| −2 | K013558 | Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw | Blackstone Medical, Inc. | 2002 | — |
| −1 | K022399 | Blackstone Spinal Fixation System Spacer | Blackstone Medical, Inc. | 2002 | — |
| 0 (this device) | K030581 | Blackstone Spinal Fixation System Lateral Offset (System Modification) | Blackstone Medical, Inc. | 2003 | — |
| +1 | K080407 | Blackstone SFS Parallel Rod Connectors | Blackstone Medical, Inc. | 2008 | 1 |
| +1 | K081684 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | 3 |
| +2 | K082797 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | — |
| +2 | K092624 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2009 | 1 |
| +2 | K100044 | Firebird Spinal Fixation System, Firebird Side-Loading Body | Blackstone | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 9 | 0 |
| 2014 | 5 | 0 |
| 2015 | 9 | 0 |
| 2016 | 12 | 0 |
| 2017 | 23 | 0 |
| 2018 | 16 | 0 |
| 2019 | 17 | 0 |
| 2020 | 23 | 0 |
| 2021 | 16 | 0 |
| 2022 | 23 | 0 |
| 2023 | 36 | 0 |
| 2024 | 33 | 0 |
| 2025 | 34 | 0 |
| 2026 | 26 | 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.
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
What was it cleared against? (11)
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 |
|---|---|---|---|
| * | K994217 | Blackstone Spinal Fixation SystemSummary page 1…I - 888.3070 - Pedicle Screw Spinal System KWP - 888.3050 - Spinal Interlaminal Fixation Orthosis Substantially Equivalent Devices: Blackstone™ Spinal Fixation System (K994217) Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screws (K020674) Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screws… | 2000 |
| * | K020674 | Blackstone Spinal Fixation System 4.5MM Multi-Axial ScrewSummary page 1…erlaminal Fixation Orthosis Substantially Equivalent Devices: Blackstone™ Spinal Fixation System (K994217) Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screws (K020674) Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screws (K013558) Blackstone™ Spinal Fixation System 2nd Gen. Cross-Connector… | 2002 |
| * | K013558 | Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewSummary page 1…stone™ Spinal Fixation System (K994217) Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screws (K020674) Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screws (K013558) Blackstone™ Spinal Fixation System 2nd Gen. Cross-Connector (K003735) Blackstone™ Spinal Fixation System Modified Multi-Axial Sc… | 2002 |
| * | K003735 | Blackstone Spinal Fixation System, Second-Generation Cross-ConnectorSummary page 1…stem 4.5mm Multi-Axial Screws (K020674) Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screws (K013558) Blackstone™ Spinal Fixation System 2nd Gen. Cross-Connector (K003735) Blackstone™ Spinal Fixation System Modified Multi-Axial Screws (K023498) Blackstone™ Spinal Fixation System Hooks (K013885) Blac… | 2001 |
| * | K023498 | Modification to Blackstone Spinal Fixation SystemSummary page 1…m 4.5mm Mono-Axial Screws (K013558) Blackstone™ Spinal Fixation System 2nd Gen. Cross-Connector (K003735) Blackstone™ Spinal Fixation System Modified Multi-Axial Screws (K023498) Blackstone™ Spinal Fixation System Hooks (K013885) Blackstone™ Spinal Fixation System Spacers (K022399) Blackstone™ Spinal Fixat… | 2002 |
| * | K013885 | Blackstone Spinal Fixation System Posterior HooksSummary page 1…nal Fixation System 2nd Gen. Cross-Connector (K003735) Blackstone™ Spinal Fixation System Modified Multi-Axial Screws (K023498) Blackstone™ Spinal Fixation System Hooks (K013885) Blackstone™ Spinal Fixation System Spacers (K022399) Blackstone™ Spinal Fixation System Staple & Washer (K022605) Device Descri… | 2002 |
| * | K022399 | Blackstone Spinal Fixation System SpacerSummary page 1…) Blackstone™ Spinal Fixation System Modified Multi-Axial Screws (K023498) Blackstone™ Spinal Fixation System Hooks (K013885) Blackstone™ Spinal Fixation System Spacers (K022399) Blackstone™ Spinal Fixation System Staple & Washer (K022605) Device Description: The Blackstone™ Spinal Fixation System is com… | 2002 |
| * | K022605 | Blackstone Spinal Fixation System Staple & WasherSummary page 1…ews (K023498) Blackstone™ Spinal Fixation System Hooks (K013885) Blackstone™ Spinal Fixation System Spacers (K022399) Blackstone™ Spinal Fixation System Staple & Washer (K022605) Device Description: The Blackstone™ Spinal Fixation System is comprised of titanium alloy (6AL-4V ELIJ, per ASTM F136) devices… | 2002 |
| * | — | Synthes device Named without a submission number | |
| * | — | Interpore Cross device Named without a submission number | |
| * | — | Surgical Dynamics device Named without a submission number |
What descends from it? (298)
See all 2983 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K080407 (Blackstone Medical, Inc., 2008) has gone furthest, with 296 descendants of its own.
- 9 other devices also cite its predicate K994217.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 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: a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; b) Who are receiving fusion using autogenous bone graft only; c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and d) Who are having the device…
Read the full statement (301 words)
The 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:
a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
d) 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:
a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
b) Fracture;
c) Dislocation;
d) Scoliosis;
e) Kyphosis;
f) Spinal tumor; and
g) Failed previous fusion (pseudarthrosis).
The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
b) spondylolistheses;
c) spinal stenosis;
d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
e) tumor;
f) pseudoarthrosis;
g) previous failed fusion; and
h) trauma (i.e., fracture or dislocation).
The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
b) spondylolistheses;
c) spinal stenosis;
d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
e) tumor;
f) pseudoarthrosis;
g) previous failed fusion; and
h) trauma (i.e., fracture or dislocation).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K030581 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030581: Blackstone Spinal Fixation System Lateral Offset (System Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030581
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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