510(k) · Cleared
ClearedIntegra Laminoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine, Inc. · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on May 9, 2013 as substantially equivalent to K091623 (Nuvasive, Inc., 2009) after a 44-day review. Its family tree reaches back 4 generations to 1976. 2 later devices descend from it.
- Decided
- May 9, 2013
- Review
- 44 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K761228 (1976). 12 ancestors in all. 2 later devices descend from it, 1 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 backK091623 Laminoplasty Fixation SystemNuvasive, Inc. · 2009
- This deviceK130830 Integra Laminoplasty SystemSeaspine, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK150469 Integra Laminoplasty SystemSeaspine, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta…SeaSpine Orthopedics Corporation · 2026
Most influential descendants
Showing 2 of 2 · See allView 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 | K091623 | Laminoplasty Fixation System | Nuvasive, Inc. | 2009 | — |
| 0 (this device) | K130830 | Integra Laminoplasty System | Seaspine, Inc. | 2013 | — |
| +1 | K150469 | Integra Laminoplasty System | Seaspine, Inc. | 2015 | — |
| +2 | 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 |
|---|---|---|
| 2015 | 1 | 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 13.0 · 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091623 | Laminoplasty Fixation SystemSummary page 1…Code: NQW, Class 11 3. Legally Marketed Predicate Device(s) 510(k) Number -Product Code -Trade Name Manufacturer K091623 NQW NuVasive (Leverage) Laminoplasty NuVasive, Inc. _____________ __… | 2009 |
| Kept off the family tree | K000290 | FDA’s K000290 is Lazersmile, Lazerwhite Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| Kept off the family tree | K050829 | FDA’s K050829 is Nurse's Assistant 1.7 O.R. Control System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150469 | Integra Laminoplasty System | 2015 | 1 |
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 37 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, K150469 (Seaspine, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K091623.
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. 2013, 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 Integra® Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) after laminoplasty procedures. The Integra® Laminoplasty 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/K130830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130830: Integra 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/K130830
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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