510(k) · Cleared
ClearedEscalate Laminoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Apr 16, 2012 as substantially equivalent to K050082 (Medtronic Sofamor Danek, Inc., 2005) and 1 other predicate after a 115-day review. Its family tree reaches back 3 generations to 1976. 7 later devices descend from it.
- Decided
- Apr 16, 2012
- Review
- 115 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. 7 later devices descend from it, 2 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 deviceK113802 Escalate Laminoplasty SystemStryker Spine · 2012
- Descendant · cites it directly · 4 of its ownK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
- Descendant · 2 generations on · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
- Descendant · 2 generations on · 1 of its ownK240872 Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024
- Descendant · cites it directly · 1 of its ownK181717 Life Spine Laminoplasty SystemLife Spine, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK253545 Vulcan Spinal SystemK2m, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine · 2023 · cites it directly4descendants
- K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · 2 generations on1descendant
- K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024 · 2 generations on1descendant
- K181717Life Spine Laminoplasty SystemLife Spine, Inc. · 2018 · cites it directly1descendant
- K253545Vulcan Spinal SystemK2m, Inc. · 2026 · 3 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) | K113802 | Escalate Laminoplasty System | Stryker Spine | 2012 | — |
| +1 | K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System… | Stryker Spine | 2023 | — |
| +2 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal… | Stryker Spine | 2024 | — |
| +2 | K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | Clariance | 2024 | — |
| +1 | K181717 | Life Spine Laminoplasty System | Life Spine, Inc. | 2018 | — |
| +3 | K253545 | Vulcan Spinal System | K2m, 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K050082 | Centerpiece Plate Fixation SystemSummary page 1…shown to be substantially equivalent to the devices listed below: * Medtronic CenterpieceTM Plate Fixation System (K050082) * Synthes ArchTM Fixation System (K032534) Device Description The EscalateTM System consists… | 2005 |
| * | K032534 | Synthes AfsSummary page 1…e devices listed below: * Medtronic CenterpieceTM Plate Fixation System (K050082) * Synthes ArchTM Fixation System (K032534) Device Description The EscalateTM System consists of a comprehensive set of implants and inst… | 2004 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 36 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K222684 (Stryker Spine, 2023) has gone furthest, with 4 descendants of its own.
- 11 other devices also cite its predicate K050082.
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. 2012, 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 Escalatem Laniinoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The system is intended to hold the lamina open following a laminoplasty procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113802 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113802: Escalate Laminoplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113802
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