510(k) · Cleared
ClearedMountaineer Laminoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Jan 7, 2010 as substantially equivalent to K050082 (Medtronic Sofamor Danek, Inc., 2005) and 1 other predicate after a 189-day review. Its family tree reaches back 3 generations to 1976. 17 later devices descend from it.
- Decided
- Jan 7, 2010
- Review
- 189 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K761228 (1976). 12 ancestors in all. 17 later devices descend from it, 7 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 deviceK091994 Mountaineer Laminoplasty SystemDepuy Spine, Inc. · 2010
- Descendant · cites it directly · 10 of its ownK121732 Canopy Laminoplasty Fixation SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 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 · 3 generations on · 4 of its ownK181846 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical…Globus Medical, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK173215 Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc. · 2012 · cites it directly10descendants
- K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc. · 2017 · cites it directly6descendants
- 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 · 3 generations on4descendants
- K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP · 2018 · cites it directly4descendants
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) | K091994 | Mountaineer Laminoplasty System | Depuy Spine, Inc. | 2010 | — |
| +1 | K121732 | Canopy Laminoplasty Fixation System | Globus Medical, Inc. | 2012 | — |
| +1 | 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 | — |
| +3 | K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate… | Globus Medical, Inc. | 2018 | — |
| +1 | K173215 | Choice Spine Laminoplasty™ Fixation System | Choicespine, LP | 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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 2 | 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 13.0 · 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? (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 |
|---|---|---|---|
| * | K050082 | Centerpiece Plate Fixation SystemSummary page 1…PRIETARY NAME: MOUNTAINEER®~z Laminoplasty System PREDICAT-E DEVICES: Medtronic CENTE.RPIECETM Plate Fixation Systemn (K(050082) Synthes ARCHT M Fixation System (1(032534) DEVICE DES3CRIPTION: The proposed MOUNTAINEER Laminoplas… | 2005 |
| * | K032534 | Synthes AfsSummary page 1…DEVICES: Medtronic CENTE.RPIECETM Plate Fixation Systemn (K(050082) Synthes ARCHT M Fixation System (1(032534) DEVICE DES3CRIPTION: The proposed MOUNTAINEER Laminoplastysizes System is an) mplant system that consis… | 2004 |
What descends from it? (17)
See all 177 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121732 | Canopy Laminoplasty Fixation System | 2012 | 10 |
| K171413 | HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System | 2017 | 6 |
| K173215 | Choice Spine Laminoplasty™ Fixation System | 2018 | 4 |
| K113218 | Pioneer Release Laminoplasty Plating System | 2012 | 1 |
| K252930 | AQUA Laminoplasty Systems | 2026 | 0 |
| K192281 | AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine… | 2019 | 0 |
| K153735 | Release Laminoplasty Fixation System | 2016 | 0 |
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 34 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K121732 (Globus Medical, Inc., 2012) has gone furthest, with 10 descendants of its own.
- 11 other devices also cite its predicate K050082.
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. 2010, this device’s year, is highlighted.
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 MOUNTAINEER® Laminoplasty Systein is intended for use in the lower cervical and upper thoracic spine (C3 1o T3) in laminoplasty procedures. The MOQUNTAINEER Laminoplasty System is used to hokd or buliress the allograft or autograft material in place in erder to prevent the allografl or autograft material from expulsion of impinging the spinai cord.
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/K091994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091994: Mountaineer Laminoplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091994
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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