510(k) · Cleared
ClearedPlymouth Thoracolumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Apr 13, 2012 as substantially equivalent to K092108 (Globus Medical, Inc., 2009) and 1 other predicate after a 93-day review. Its family tree reaches back 7 generations to 1999. 41 later devices descend from it.
- Decided
- Apr 13, 2012
- Review
- 93 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K990745 (1999). 20 ancestors in all, the oldest K962628 (1997). 41 later devices descend from it, 8 citing it directly.
- Root · 7 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 5 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 4 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 3 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 2 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 1 generation backK092108 Truss Thoracolumbar Plate SystemGlobus Medical, Inc. · 2009
- This deviceK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · cites it directly · 14 of its ownK140260 Skyhawk Lateral Plate SystemOrthofix, Inc. · 2014
- Descendant · cites it directly · 10 of its ownK172131 2 Hole Lateral Plating SystemLife Spine, Inc. · 2017
- Descendant · 2 generations on · 9 of its ownK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
- Descendant · 2 generations on · 9 of its ownK180166 Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K190016Lateral Plate SystemCorelink, LLC · 2019 · cites it directly15descendants
- K140260Skyhawk Lateral Plate SystemOrthofix, Inc. · 2014 · cites it directly14descendants
- K1721312 Hole Lateral Plating SystemLife Spine, Inc. · 2017 · cites it directly10descendants
- K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021 · 2 generations on9descendants
- K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −6 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −5 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −4 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −3 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −2 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −1 | K092108 | Truss Thoracolumbar Plate System | Globus Medical, Inc. | 2009 | — |
| 0 (this device) | K120092 | Plymouth Thoracolumbar Plate System | Globus Medical, Inc. | 2012 | — |
| +1 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +1 | K140260 | Skyhawk Lateral Plate System | Orthofix, Inc. | 2014 | — |
| +1 | K172131 | 2 Hole Lateral Plating System | Life Spine, Inc. | 2017 | — |
| +2 | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | 2021 | — |
| +2 | K180166 | Life Spine Lumbar Fixation System (SENTRY) | Life Spine, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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 |
|---|---|---|---|
| * | K092108 | Truss Thoracolumbar Plate SystemSummary page 1…ion Orthosis Product Code: KWO. Regulatory Class: 11,Panel Code: 87. Predicate(s): TRUSS® Thorac 'olumbar Plate System (K0921 08) SE date: August 13, 2009 Nuvasive Lateral Plate System (K091 071)… | 2009 |
| * | K091071 | Nuvasive Lateral Plate SystemSummary page 1…7. Predicate(s): TRUSS® Thorac 'olumbar Plate System (K0921 08) SE date: August 13, 2009 Nuvasive Lateral Plate System (K091 071) SE dates: May 8, 2009 Purpose: The purpose of this submission is to request clearance for the PLYMOUITHTM… | 2009 |
What descends from it? (41)
See all 418 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190016 | Lateral Plate System | 2019 | 15 |
| K140260 | Skyhawk Lateral Plate System | 2014 | 14 |
| K172131 | 2 Hole Lateral Plating System | 2017 | 10 |
| K200846 | Balteum™ Lumbar Plate System | 2020 | 4 |
| K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP… | 2018 | 4 |
| K213820 | BALTEUM - ONE™ Lumbar Plate System | 2022 | 3 |
| K183214 | Raven Lumbar Plate System | 2019 | 2 |
| K233735 | ADIRA™ Lateral Plate 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 13 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K190016 (Corelink, LLC, 2019) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K092108.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The PLYMOUTH Tm Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120092: Plymouth Thoracolumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120092
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