510(k) · Cleared
ClearedCuriteva Laminoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curiteva, Inc. · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Jun 28, 2023 as substantially equivalent to K032534 (Synthes Spine, 2004) and 3 other predicates after a 61-day review. Its family tree reaches back 6 generations to 1976. 2 later devices descend from it.
- Decided
- Jun 28, 2023
- Review
- 61 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K761228 (1976). 19 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 5 generations backK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 4 generations backK032534 Synthes AfsSynthes Spine · 2004
- 3 generations backK043338 Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc. · 2005
- 2 generations backK080664 Relieve Laminoplasty Fixation SystemGlobus Medical, Inc. · 2008
- 1 generation backK121732 Canopy Laminoplasty Fixation SystemGlobus Medical, Inc. · 2012
- This deviceK231232 Curiteva Laminoplasty SystemCuriteva, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK243137 Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK252205 Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK…Curiteva, Inc. · 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 |
|---|---|---|---|---|---|
| −6 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −5 | K963741 | Leibinger Luhr Small Craniomaxillofacial Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −4 | K032534 | Synthes Afs | Synthes Spine | 2004 | — |
| −3 | K043338 | Blakstone Laminoplasty Fixation System | Blackstone Medical, Inc. | 2005 | — |
| −2 | K080664 | Relieve Laminoplasty Fixation System | Globus Medical, Inc. | 2008 | — |
| −1 | K121732 | Canopy Laminoplasty Fixation System | Globus Medical, Inc. | 2012 | — |
| 0 (this device) | K231232 | Curiteva Laminoplasty System | Curiteva, Inc. | 2023 | — |
| +1 | K243137 | Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. | 2024 | — |
| +2 | K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar… | Curiteva, Inc. | 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 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 13.1 · 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? (4)
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 4…roduct Code: NQW Classification Panel: Division of Orthopedic Devices Predicate Device(s): Primary: Synthes Arch Fixation System (K032534) Additional: Choice Spine Laminoplasty Fixation System (K1732… | 2004 |
| * | K173215 | Choice Spine Laminoplasty™ Fixation SystemSummary page 4…rimary: Synthes Arch Fixation System (K032534) Additional: Choice Spine Laminoplasty Fixation System (K173215) Additional: Globus Medical Canopy Laminoplasty Fixation Syst… | 2018 |
| * | K121732 | Canopy Laminoplasty Fixation SystemSummary page 4…(K173215) Additional: Globus Medical Canopy Laminoplasty Fixation System (K121732) Additional: Nuvasive Laminoplasty System (K091623) Reference… | 2012 |
| * | K091623 | Laminoplasty Fixation SystemSummary page 4…lobus Medical Canopy Laminoplasty Fixation System (K121732) Additional: Nuvasive Laminoplasty System (K091623) Reference: Curiteva Cervical Interbody Fusion System (K18126… | 2009 |
| † | K181261 | Curiteva Cervical Interbody Fusion System | 2018 |
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 |
|---|---|---|---|
| K243137 | Curiteva Porous PEEK Laminoplasty System | 2024 | 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 47 years and passes through 6 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K243137 (Curiteva, Inc., 2024) 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. 2023, 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 Curiteva Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal 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/K231232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231232: Curiteva 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/K231232
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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