510(k) · Cleared
ClearedVy Spine™ VyLam™ Laminoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vy Spine, LLC · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Oct 10, 2023 as substantially equivalent to K032534 (Synthes Spine, 2004) and 1 other predicate after a 55-day review. Its family tree reaches back 5 generations to 1976. 1 later device descends from it.
- Decided
- Oct 10, 2023
- Review
- 55 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K761228 (1976). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 4 generations backK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 3 generations backK032534 Synthes AfsSynthes Spine · 2004
- 2 generations backK043338 Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc. · 2005
- 1 generation backK100805 Gallery Laminoplasty Fixation SystemBiomet Spine (Aka Ebi, LLC) · 2010
- This deviceK232471 Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2023
- Descendant · cites it directly · 0 of its ownK242784 Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −4 | K963741 | Leibinger Luhr Small Craniomaxillofacial Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −3 | K032534 | Synthes Afs | Synthes Spine | 2004 | — |
| −2 | K043338 | Blakstone Laminoplasty Fixation System | Blackstone Medical, Inc. | 2005 | — |
| −1 | K100805 | Gallery Laminoplasty Fixation System | Biomet Spine (Aka Ebi, LLC) | 2010 | — |
| 0 (this device) | K232471 | Vy Spine™ VyLam™ Laminoplasty System | Vy Spine, LLC | 2023 | — |
| +1 | K242784 | Vy Spine™ VyLam™ Laminoplasty System | Vy Spine, LLC | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 4…y System Classification Name: Spinal Interlaminal Fixation Orthosis Regulation Number: 21 CFR 888.3050 Product Code: NQW Primary Predicate: Synthes ARCH Fixation System (K032534) Additional Predicate: Gallery Laminoplasty System (K100805) Substantial Equivalence: The subject Vy Spine™ VyLam™ Laminoplasty… | 2004 |
| * | K100805 | Gallery Laminoplasty Fixation SystemSummary page 4…rthosis Regulation Number: 21 CFR 888.3050 Product Code: NQW Primary Predicate: Synthes ARCH Fixation System (K032534) Additional Predicate: Gallery Laminoplasty System (K100805) Substantial Equivalence: The subject Vy Spine™ VyLam™ Laminoplasty System is substantially equivalent to the legally marketed… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242784 | Vy Spine™ VyLam™ Laminoplasty System | 2024 | 0 |
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 13 ancestors has a recall of any class.
- Of its descendants, K242784 (Vy Spine, LLC, 2024) has gone furthest, with 0 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. 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 Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232471 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232471: Vy Spine™ VyLam™ Laminoplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232471
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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