510(k) · Cleared
ClearedGallery Laminoplasty Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine (Aka Ebi, LLC) · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Jul 20, 2010 as substantially equivalent to K032534 (Synthes Spine, 2004) and 1 other predicate after a 120-day review. Its family tree reaches back 4 generations to 1976. 3 later devices descend from it.
- Decided
- Jul 20, 2010
- Review
- 120 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K761228 (1976). 12 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 3 generations backK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 2 generations backK032534 Synthes AfsSynthes Spine · 2004
- 1 generation backK043338 Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc. · 2005
- This deviceK100805 Gallery Laminoplasty Fixation SystemBiomet Spine (Aka Ebi, LLC) · 2010
- Descendant · cites it directly · 1 of its ownK232471 Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK242784 Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2024
- Descendant · cites it directly · 0 of its ownK202309 Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty…Zimmer Biomet Spine, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2023 · cites it directly1descendant
- K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2024 · 2 generations on0descendants
- K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −3 | K963741 | Leibinger Luhr Small Craniomaxillofacial Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K032534 | Synthes Afs | Synthes Spine | 2004 | — |
| −1 | K043338 | Blakstone Laminoplasty Fixation System | Blackstone Medical, Inc. | 2005 | — |
| 0 (this device) | K100805 | Gallery Laminoplasty Fixation System | Biomet Spine (Aka Ebi, LLC) | 2010 | — |
| +1 | K232471 | Vy Spine™ VyLam™ Laminoplasty System | Vy Spine, LLC | 2023 | — |
| +2 | K242784 | Vy Spine™ VyLam™ Laminoplasty System | Vy Spine, LLC | 2024 | — |
| +1 | K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation… | Zimmer Biomet Spine, Inc. | 2020 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 13.0 · 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 |
|---|---|---|---|
| * | K032534 | Synthes AfsSummary page 1…Device Classification: 21 CFR §888.3050 Product Code: NQW Predicate Device: Synthes ARCH Fixation System (K032534) Blackstone Laminoplasty Fixation System (K043338) Device Description: The Galler… | 2004 |
| * | K043338 | Blakstone Laminoplasty Fixation SystemSummary page 1…Product Code: NQW Predicate Device: Synthes ARCH Fixation System (K032534) Blackstone Laminoplasty Fixation System (K043338) Device Description: The GalleryTm Laminoplasty Fixation System consists of impla… | 2005 |
What descends from it? (3)
2 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 34 years and passes through 5 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, K232471 (Vy Spine, LLC, 2023) has gone furthest, with 1 descendant 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. 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 Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Gallery Lamninoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100805: Gallery Laminoplasty Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100805
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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