510(k) · Cleared
ClearedBlakstone Laminoplasty Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Feb 18, 2005 as substantially equivalent to K032534 (Synthes Spine, 2004) after a 77-day review. Its family tree reaches back 3 generations to 1976. 17 later devices descend from it.
- Decided
- Feb 18, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K761228 (1976). 11 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 2 generations backK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 1 generation backK032534 Synthes AfsSynthes Spine · 2004
- This deviceK043338 Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc. · 2005
- Descendant · cites it directly · 11 of its ownK080664 Relieve Laminoplasty Fixation SystemGlobus Medical, Inc. · 2008
- Descendant · 2 generations on · 10 of its ownK121732 Canopy Laminoplasty Fixation SystemGlobus Medical, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK171413 HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 5 of its ownK180156 SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty…Globus Medical, Inc. · 2018
- Descendant · 2 generations on · 4 of its ownK181846 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical…Globus Medical, Inc. · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K080664Relieve Laminoplasty Fixation SystemGlobus Medical, Inc. · 2008 · cites it directly11descendants
- K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc. · 2012 · 2 generations on10descendants
- K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc. · 2017 · 2 generations on6descendants
- K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc. · 2018 · 2 generations on5descendants
- K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc. · 2018 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −2 | K963741 | Leibinger Luhr Small Craniomaxillofacial Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −1 | K032534 | Synthes Afs | Synthes Spine | 2004 | — |
| 0 (this device) | K043338 | Blakstone Laminoplasty Fixation System | Blackstone Medical, Inc. | 2005 | — |
| +1 | K080664 | Relieve Laminoplasty Fixation System | Globus Medical, Inc. | 2008 | — |
| +2 | K121732 | Canopy Laminoplasty Fixation System | Globus Medical, Inc. | 2012 | — |
| +2 | K171413 | HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System | Globus Medical, Inc. | 2017 | — |
| +2 | K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | Globus Medical, Inc. | 2018 | — |
| +2 | K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate… | Globus Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2026 | 1 | 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 NQW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NQW device
- #1 K243137 Curiteva Porous PEEK Laminoplasty Systemscore 13.1 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K032534 | Synthes AfsSummary page 1…Code & Classification: NQW- 888.3050 -Orthosis, Spine, Plate, Laminoplasty, Metal Substantially Equivalent Devices: Synthes ArchTm Fixation System (K032534) Device Description: The Blackstone Laminoplasty Fixation System is a device comprised of non-sterile, single use, titani… | 2004 |
What descends from it? (17)
See all 173 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 29 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K080664 (Globus Medical, Inc., 2008) has gone furthest, with 11 descendants of its own.
- 17 other devices also cite its predicate K032534.
How does its category compare?
All NQW devicesNQW Orthosis, Spine, Plate, Laminoplasty, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NQW
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NQW
84in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQW
No recall names NQW since 2007.
Adverse event reports per year · NQW
33in 2025
MAUDE reports naming product code NQW, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 3 | 120 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 120 | 0 | 1 |
| 2013 | 3 | 84 | 0 | 49 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 19 |
| 2018 | 2 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 2 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Blackstone Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043338 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043338: Blakstone Laminoplasty Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043338
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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