510(k) · Cleared
ClearedHAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Jul 14, 2017 as substantially equivalent to K121732 (Globus Medical, Inc., 2012) and 2 other predicates after a 60-day review. Its family tree reaches back 6 generations to 1976. 6 later devices descend from it.
- Decided
- Jul 14, 2017
- Review
- 60 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K761228 (1976). 16 ancestors in all. 6 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 deviceK171413 HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK180156 SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty…Globus Medical, Inc. · 2018
- Descendant · 2 generations on · 4 of its ownK181846 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical…Globus Medical, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- Descendant · 4 generations on · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK233735 ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc. · 2018 · cites it directly5descendants
- K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc. · 2018 · 2 generations on4descendants
- K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · 3 generations on2descendants
- K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024 · 4 generations on0descendants
- K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024 · 3 generations on0descendants
View 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) | K171413 | HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System | Globus Medical, Inc. | 2017 | — |
| +1 | K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | Globus Medical, Inc. | 2018 | — |
| +2 | K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate… | Globus Medical, Inc. | 2018 | — |
| +3 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
| +4 | K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024 | — |
| +3 | K233735 | ADIRA™ Lateral Plate System | Globus Medical, Inc. | 2024 | — |
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 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121732 | Canopy Laminoplasty Fixation SystemSummary page 5…Product Code: NQW Regulatory Class: II, Panel Code: 87 Primary Predicate: CANOPY® Laminoplasty Fixation System (K121732) Additional Predicates: RELIEVE® Laminoplasty Fixation System (K080664) Mountaineer Laminoplasty S… | 2012 |
| * | K080664 | Relieve Laminoplasty Fixation SystemSummary page 5…: II, Panel Code: 87 Primary Predicate: CANOPY® Laminoplasty Fixation System (K121732) Additional Predicates: RELIEVE® Laminoplasty Fixation System (K080664) Mountaineer Laminoplasty System (K091994) Reference REVERE® Stabilization System (K133350) Devi… | 2008 |
| * | K091994 | Mountaineer Laminoplasty SystemSummary page 5…noplasty Fixation System (K121732) Additional Predicates: RELIEVE® Laminoplasty Fixation System (K080664) Mountaineer Laminoplasty System (K091994) Reference REVERE® Stabilization System (K133350) Device: Purpose: The purpose of this submission is to request clea… | 2010 |
| † | K133350 | Revere Stabilization System | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | 2018 | 5 |
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 41 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K180156 (Globus Medical, Inc., 2018) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K121732.
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. 2017, 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 HAVEN™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The HAVEN™ Laminoplasty System is used to hold bone allograft or autograft material in place in order to prevent the graft from expulsion or impinging the spinal cord.
The CANOPY® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY® Laminoplasty Fixation System is used to hold bone allograft or autograft material in place in order to prevent the graft from expulsion or impinging the spinal cord.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171413: HAVEN™ Laminoplasty System, CANOPY® 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/K171413
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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