510(k) · Cleared
ClearedSynthes Thoracolumbar Spine Locking Plate (TSLP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Apr 22, 2002 after an 88-day review. The FDA summary names no predicate by number. 117 later devices descend from it.
- Decided
- Apr 22, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
117 later devices descend from it, 7 citing it directly.
- This deviceK020244 Synthes Thoracolumbar Spine Locking Plate (TSLP)Synthes Spine · 2002
- Descendant · cites it directly · 87 of its ownK072407 Bodyform Thoracic Fixation SystemTheken Spine, LLC · 2007
- Descendant · cites it directly · 73 of its ownK091253 Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model…K2m, Inc. · 2009
- Descendant · 2 generations on · 72 of its ownK131533 Cayman MI Plate SystemK2m, Inc. · 2013
- Descendant · 3 generations on · 52 of its ownK172941 CASCADIA Interbody SystemK2m · 2018
- Descendant · 4 generations on · 24 of its ownK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 117 · See all- K072407Bodyform Thoracic Fixation SystemTheken Spine, LLC · 2007 · cites it directly87descendants
- K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc. · 2009 · cites it directly73descendants
- K131533Cayman MI Plate SystemK2m, Inc. · 2013 · 2 generations on72descendants
- K172941CASCADIA Interbody SystemK2m · 2018 · 3 generations on52descendants
- K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020244 | Synthes Thoracolumbar Spine Locking Plate (TSLP) | Synthes Spine | 2002 | — |
| +1 | K072407 | Bodyform Thoracic Fixation System | Theken Spine, LLC | 2007 | — |
| +1 | K091253 | Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral… | K2m, Inc. | 2009 | — |
| +2 | K131533 | Cayman MI Plate System | K2m, Inc. | 2013 | — |
| +3 | K172941 | CASCADIA Interbody System | K2m | 2018 | — |
| +4 | K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 13 | 0 |
| 2023 | 22 | 0 |
| 2024 | 20 | 0 |
| 2025 | 16 | 0 |
| 2026 | 18 | 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?
The FDA summary names no predicate by number.
What descends from it? (117)
See all 1177 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072407 | Bodyform Thoracic Fixation System | 2007 | 87 |
| K091253 | Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate… | 2009 | 73 |
| K122733 | V2F Anterior Fixation System | 2012 | 17 |
| K173885 | Genesys Spine Binary Lumbar Plate System | 2018 | 4 |
| K162211 | AccuFit Lateral Plate System | 2016 | 4 |
| K202624 | Z-Span Plate System | 2020 | 1 |
| K153097 | Belvedere™ Lateral Plating System | 2016 | 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?
- Of its descendants, K072407 (Theken Spine, LLC, 2007) has gone furthest, with 87 descendants of its own.
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.
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 Synthes TSLP System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and 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 a failed previous spine surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020244: Synthes Thoracolumbar Spine Locking Plate (TSLP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020244
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