510(k) · Cleared
ClearedThor Anterior Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jun 9, 2008 as substantially equivalent to K073437 (Stryker Spine, 2008) and 3 other predicates after an 82-day review. Its family tree reaches back 3 generations to 1998. 101 later devices descend from it.
- Decided
- Jun 9, 2008
- Review
- 82 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K983583 (1998). 6 ancestors in all. 101 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK983583 Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 2 generations backK994347 Centaur Spinal SystemHowmedica Osteonics Corp. · 2000
- 1 generation backK073437 Thor Anterior Plating SystemStryker Spine · 2008 · Recalled
- This deviceK080773 Thor Anterior Plating SystemStryker Spine · 2008
- 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 · cites it directly · 46 of its ownK142699 LITe Plate SystemStryker Corporation · 2014
- Descendant · 4 generations on · 24 of its ownK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
Showing 5 of 101 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 101 · See all- 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
- K142699LITe Plate SystemStryker Corporation · 2014 · cites it directly46descendants
- 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 |
|---|---|---|---|---|---|
| −3 | K983583 | Depuy Acromed Moss and Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −2 | K994347 | Centaur Spinal System | Howmedica Osteonics Corp. | 2000 | — |
| −1 | K073437 | Thor Anterior Plating System | Stryker Spine | 2008 | 31 |
| 0 (this device) | K080773 | Thor Anterior Plating System | Stryker Spine | 2008 | — |
| +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 | — |
| +1 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
| +4 | K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 11 | 0 |
| 2023 | 20 | 0 |
| 2024 | 16 | 0 |
| 2025 | 13 | 0 |
| 2026 | 16 | 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? (4)
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 |
|---|---|---|---|
| * | K073437 | Thor Anterior Plating SystemSummary page 1…Fixation Orthosis and Number 21 CFR 888.3060 Product Code KWQ Predicate Devices Stryker Spine THOR Anterior Plating System: 510(k) #K073437 Stryker Spine CENTAUR Spinal System: 510(k) #K994347,#KOO 1844 Stryker Spine… | 2008 |
| * | K994347 | Centaur Spinal SystemSummary page 1…KWQ Predicate Devices Stryker Spine THOR Anterior Plating System: 510(k) #K073437 Stryker Spine CENTAUR Spinal System: 510(k) #K994347,#KOO 1844 Stryker Spine Xia Stainless Steel System: 510(k) #K012870 Device Description The Str… | 2000 |
| * | K001844 | Modification to Centaur Spinal SystemSummary page 4…trated equivalent mechanical performance characteristics to the Stryker Spine CENTAUR Spinal System [5 10(k) K994347, K001844] and Stryker Spine Xia Stainless Steel System [510(k) K012870]. The subject T… | 2000 |
| * | K012870 | Xia Stainless Steel SystemSummary page 1…3437 Stryker Spine CENTAUR Spinal System: 510(k) #K994347,#KOO 1844 Stryker Spine Xia Stainless Steel System: 510(k) #K012870 Device Description The Stryker Spine THORTM Anterior Plating System is designed for anterior a… | 2001 |
What descends from it? (101)
See all 1012 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 10 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K091253 (K2m, Inc., 2009) has gone furthest, with 73 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. 2008, 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?
When used as an anterior non-pedicle fixation system in the lumbar and lumbosacral spine (LI-Sl), THOR Anterior Plating System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels. THOR Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or…
Read the full statement (203 words)
When used as an anterior non-pedicle fixation system in the lumbar and lumbosacral spine (LI-Sl), THOR Anterior Plating System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels. THOR Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
1) Degenerative Disc Disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
2) Pseudoarthrosis
3) Spondylolysis
4) Spondyloisthesis
5) Trauma (i.e. Fracture of Dislocation)
6) Deformities (i.e. Scoliosis or Lordosis)
7) Spinal Stenosis
8) Failed previous Fusion
When used as an anterolateral non-pedicle fixation system in the thoracic and thoracolumbar spine (Tl1-5), THOR Anterior Piating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
1) Degenerative disc Disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
2) Trauma (i.e. Fracture or Dislocation)
3) Spinal Stenosis
4) Deformities (i.e. Scoliosis, Kyphosis and/or Lordosis)
5) Tumors
6) Failed Previous Fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080773 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080773: Thor Anterior Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080773
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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