510(k) · Cleared
ClearedLaminoplasty Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Oct 9, 2009 as substantially equivalent to K032534 (Synthes Spine, 2004) after a 128-day review. Its family tree reaches back 3 generations to 1976. 7 later devices descend from it.
- Decided
- Oct 9, 2009
- Review
- 128 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. 7 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 deviceK091623 Laminoplasty Fixation SystemNuvasive, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK231232 Curiteva Laminoplasty SystemCuriteva, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK130830 Integra Laminoplasty SystemSeaspine, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK243137 Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK150469 Integra Laminoplasty SystemSeaspine, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta…SeaSpine Orthopedics Corporation · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K231232Curiteva Laminoplasty SystemCuriteva, Inc. · 2023 · cites it directly2descendants
- K130830Integra Laminoplasty SystemSeaspine, Inc. · 2013 · cites it directly2descendants
- K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc. · 2024 · 2 generations on1descendant
- K150469Integra Laminoplasty SystemSeaspine, Inc. · 2015 · 2 generations on1descendant
- K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation · 2026 · 3 generations on0descendants
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) | K091623 | Laminoplasty Fixation System | Nuvasive, Inc. | 2009 | — |
| +1 | K231232 | Curiteva Laminoplasty System | Curiteva, Inc. | 2023 | — |
| +1 | K130830 | Integra Laminoplasty System | Seaspine, Inc. | 2013 | — |
| +2 | K243137 | Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. | 2024 | — |
| +2 | K150469 | Integra Laminoplasty System | Seaspine, Inc. | 2015 | — |
| +3 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… | SeaSpine Orthopedics Corporation | 2026 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 13.1 · 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…NQW C. Predicate Devices The subject device is substantially equivalent to similar previously cleared device, Synthes's ArchTM System (K032534) that is currently distributed commercially in U.S. D. Device Description The NuVasive Lam inoplasty Fixation S… | 2004 |
What descends from it? (7)
3 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 33 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, K231232 (Curiteva, Inc., 2023) has gone furthest, with 2 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. 2009, 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 NuVasive Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Laminoplasty Fixation System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091623 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091623: Laminoplasty Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091623
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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