510(k) · Cleared
ClearedSpectrum Spine Laminoplasty Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Spine, LLC · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Feb 7, 2013 as substantially equivalent to K032534 (Synthes Spine, 2004) and 1 other predicate after a 146-day review. Its family tree reaches back 3 generations to 1976. 5 later devices descend from it.
- Decided
- Feb 7, 2013
- Review
- 146 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K761228 (1976). 12 ancestors in all. 5 later devices descend from it, 1 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 deviceK122822 Spectrum Spine Laminoplasty Plating SystemSpectrum Spine, LLC · 2013
- Descendant · cites it directly · 4 of its ownK173215 Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP · 2018
- Descendant · 2 generations on · 2 of its ownK231232 Curiteva Laminoplasty SystemCuriteva, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK243137 Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK252205 Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK…Curiteva, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK191927 Hinged Laminoplasty SystemLife Spine, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP · 2018 · cites it directly4descendants
- K231232Curiteva Laminoplasty SystemCuriteva, Inc. · 2023 · 2 generations on2descendants
- K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc. · 2024 · 3 generations on1descendant
- K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc. · 2026 · 4 generations on0descendants
- K191927Hinged Laminoplasty SystemLife Spine, Inc. · 2019 · 2 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) | K122822 | Spectrum Spine Laminoplasty Plating System | Spectrum Spine, LLC | 2013 | — |
| +1 | K173215 | Choice Spine Laminoplasty™ Fixation System | Choicespine, LP | 2018 | — |
| +2 | K231232 | Curiteva Laminoplasty System | Curiteva, Inc. | 2023 | — |
| +3 | K243137 | Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. | 2024 | — |
| +4 | K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar… | Curiteva, Inc. | 2026 | — |
| +2 | K191927 | Hinged Laminoplasty System | Life Spine, Inc. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 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? (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…______ Classification Panel: orthopedic and Rehabilitation Devices Panel PredcateDevies: ynths Arh t M ixaion System (AFS) (K032534)I M Medtonic Ceteriece M Plate Fixation S… | 2004 |
| * | K050082 | Centerpiece Plate Fixation SystemSummary page 1…M ixaion System (AFS) (K032534)I M Medtonic Ceteriece M Plate Fixation System (K(050082) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Spectrum Spine Laminoplasty Plating System is comprised of va… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173215 | Choice Spine Laminoplasty™ Fixation System | 2018 | 4 |
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 4 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K173215 (Choicespine, LP, 2018) has gone furthest, with 4 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. 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 Spectrum Spine Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Spectrum Spine Laminoplasty Plating 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/K122822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122822: Spectrum Spine Laminoplasty Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122822
Report an extraction error
Are you the manufacturer?
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