510(k) · Cleared
ClearedBlackstone Spinal Fixation System Rigid Cross Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Apr 17, 2003 as substantially equivalent to K994217 (Blackstone Medical, Inc., 2000) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 2000. 297 later devices descend from it.
- Decided
- Apr 17, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K994217 (2000). 2 ancestors in all. 297 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK994217 Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2000
- This deviceK030862 Blackstone Spinal Fixation System Rigid Cross ConnectorBlackstone 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 297 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 297 · 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 |
|---|---|---|---|---|---|
| −1 | K994217 | Blackstone Spinal Fixation System | Blackstone Medical, Inc. | 2000 | — |
| 0 (this device) | K030862 | Blackstone Spinal Fixation System Rigid Cross Connector | 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 |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994217 | Blackstone Spinal Fixation SystemSummary page 1…Orthosis MNI - 888.3070 - Pedicle Screw Spinal System Substantially Equivalent Device: BlackstoneTMSpinal Fixation System (K9942 17) BlackstoneTMSpinal Fixation System Second Generation Cross Connec… | 2000 |
| * | K003735 | Blackstone Spinal Fixation System, Second-Generation Cross-ConnectorSummary page 3…SIS OF SUBSTANTIAL EQUIVALENCE: The Blackstone Rigid Cross Connector, by its very nature, is substantially equivalent to the Blackstone Spinal Fixation System (K994217, K003735), which has been cleared by the FDA for certain anterior and pedicle fixation indications. Summary… | 2001 |
What descends from it? (297)
See all 2972 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?
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 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: - 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…
Read the full statement (299 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:
- 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:
a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
b) Fracture;
c) Dislocation;
d) Scoliosis;
e) Kyphosis;
f) Spinal tumor;
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) Spinal stenosis;
c) Spondylolisthesis;
d) Spinal deformities (i.e., scoliosis, kyphosis, lordosis);
e) Pseudoarthrosis;
f) Tumor;
g) Trauma (i.e., fracture or dislocation).
h) Failed previous fusion.
The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spinal stenosis;
c) Spondylolisthesis;
d) Spinal deformities (i.e., scoliosis, kyphosis and/or lordosis);
e) Pseudo arthrosis;
f) Tumor;
g) Trauma (i.e., fracture or dislocation);
h) Failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030862: Blackstone Spinal Fixation System Rigid Cross Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030862
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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