510(k) · Cleared
Recalled · 2009Thor 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 Feb 13, 2008 as substantially equivalent to K022791 (Synthes (Usa), 2002) and 3 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1998. 102 later devices descend from it. It has been recalled 31 times.
- Decided
- Feb 13, 2008
- Review
- 69 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 31
- Predicates
- 4
Its longest line of descent runs back 2 generations to K983583 (1998). 5 ancestors in all. 102 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK983583 Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 1 generation backK994347 Centaur Spinal SystemHowmedica Osteonics Corp. · 2000
- This deviceK073437 Thor Anterior Plating SystemStryker Spine · 2008
- Descendant · cites it directly · 101 of its ownK080773 Thor Anterior Plating SystemStryker Spine · 2008
- Descendant · 2 generations on · 73 of its ownK091253 Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model…K2m, Inc. · 2009
- Descendant · 3 generations on · 72 of its ownK131533 Cayman MI Plate SystemK2m, Inc. · 2013
- Descendant · 4 generations on · 52 of its ownK172941 CASCADIA Interbody SystemK2m · 2018
- Descendant · 2 generations on · 46 of its ownK142699 LITe Plate SystemStryker Corporation · 2014
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K080773Thor Anterior Plating SystemStryker Spine · 2008 · cites it directly101descendants
- K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc. · 2009 · 2 generations on73descendants
- K131533Cayman MI Plate SystemK2m, Inc. · 2013 · 3 generations on72descendants
- K172941CASCADIA Interbody SystemK2m · 2018 · 4 generations on52descendants
- K142699LITe Plate SystemStryker Corporation · 2014 · 2 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983583 | Depuy Acromed Moss and Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −1 | K994347 | Centaur Spinal System | Howmedica Osteonics Corp. | 2000 | — |
| 0 (this device) | K073437 | Thor Anterior Plating System | Stryker Spine | 2008 | — |
| +1 | K080773 | Thor Anterior Plating System | Stryker Spine | 2008 | — |
| +2 | K091253 | Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral… | K2m, Inc. | 2009 | — |
| +3 | K131533 | Cayman MI Plate System | K2m, Inc. | 2013 | — |
| +4 | K172941 | CASCADIA Interbody System | K2m | 2018 | — |
| +2 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K022791 | Synthes Anterior Tension Band (Atb) SystemSummary page 1…Body Fixation Orthosis and Number 21 CFR 888.3060 Product Code KWQ Predicate Devices Synthes Anterior Tension Band System: 510(k) #K022791 Stryker Spine CENTAUR Spinal System: 510(k) #K994347,#K001844 Stryker Spine X… | 2002 |
| * | K994347 | Centaur Spinal SystemSummary page 1…KWQ Predicate Devices Synthes Anterior Tension Band System: 510(k) #K022791 Stryker Spine CENTAUR Spinal System: 510(k) #K994347,#K001844 Stryker Spine Xia Stainless Steel System: 510(k) #K012870 Device Description The Stry… | 2000 |
| * | K001844 | Modification to Centaur Spinal SystemSummary page 1…KWQ Predicate Devices Synthes Anterior Tension Band System: 510(k) #K022791 Stryker Spine CENTAUR Spinal System: 510(k) #K994347,#K001844 Stryker Spine Xia Stainless Steel System: 510(k) #K012870 Device Description The Stryker Spine… | 2000 |
| * | K012870 | Xia Stainless Steel SystemSummary page 1…22791 Stryker Spine CENTAUR Spinal System: 510(k) #K994347,#K001844 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? (102)
See all 1021 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080773 | Thor Anterior Plating System | 2008 | 101 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2009 | Not classified | Z-0426-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0427-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0430-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0435-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0441-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0442-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0447-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0453-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0431-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0432-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0433-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0434-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0440-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0454-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0424-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0425-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0436-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0439-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0443-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0445-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0446-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0449-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0428-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0450-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0451-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0452-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0429-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0437-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0438-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0444-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
| Oct 2, 2009 | Not classified | Z-0448-2010 | Device Design | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break… |
The 5 latest of 31 recalls; the web page lists all.
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 7.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K080773 (Stryker Spine, 2008) has gone furthest, with 101 descendants of its own.
- 14 other devices also cite its predicate K022791.
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?
The Stryker Spine THOR TM Anterior Plating System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach below the bifurcation of the great vessels. The Styker Spine THORTM Anterior Plating System is intended for use in the lumbar and lumbosacral spine (L1-Si). THOR"4 Anterior Plating System is intended to provide additional support during fusion using…
Read the full statement (137 words)
The Stryker Spine THOR TM Anterior Plating System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach below the bifurcation of the great vessels.
The Styker Spine THORTM Anterior Plating System is intended for use in the lumbar and lumbosacral spine (L1-Si). THOR"4 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:
* Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
* Pseudoarthrosis;
* Spondylolysis;
* Spondylolisthesis;
* Trauma (i.e., fracture or dislocation);
* Deformities (i.e., scoliosis or lordosis)
* Spinal Stenosis; and
* Failed Previous Fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073437 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073437: Thor Anterior Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073437
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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