510(k) · Cleared
ClearedBodyform Thoracic Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Spine, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Dec 21, 2007 as substantially equivalent to K983622 (Theken Surgical,Llc, 1998) and 2 other predicates after a 116-day review. Its family tree reaches back 2 generations to 1996. 87 later devices descend from it.
- Decided
- Dec 21, 2007
- Review
- 116 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K955348 (1996). 5 ancestors in all. 87 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 1 generation backK041592 Coral Spinal SystemTheken Surgical · 2004 · Recalled
- This deviceK072407 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
- Descendant · 3 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 87 · 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
- K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018 · 4 generations on24descendants
- K190016Lateral Plate SystemCorelink, LLC · 2019 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −1 | K041592 | Coral Spinal System | Theken Surgical | 2004 | 1 |
| 0 (this device) | 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 | — |
| +3 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 10 | 0 |
| 2023 | 14 | 0 |
| 2024 | 15 | 0 |
| 2025 | 16 | 0 |
| 2026 | 15 | 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? (3)
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 |
|---|---|---|---|
| * | K983622 | Bodyform Thoraco-Lumbar Fixation SystemSummary page 1…osis Predicate Device: BodyForMmT Thoraco-Lumnbar Fixation System, Theken Spine, LLC (K983622) Thoracolumbar Spine Locking Plate System, Synthes (K020244)… | 1998 |
| * | K020244 | Synthes Thoracolumbar Spine Locking Plate (TSLP)Summary page 1…Spine, LLC (K983622) Thoracolumbar Spine Locking Plate System, Synthes (K020244) Coral Spinal System, Theken Spine, LLC (K041592) Device Description:… | 2002 |
| * | K041592 | Coral Spinal SystemSummary page 1…Thoracolumbar Spine Locking Plate System, Synthes (K020244) Coral Spinal System, Theken Spine, LLC (K041592) Device Description: The purpose of this submission is for additional sizes of plates and… | 2004 |
What descends from it? (87)
See all 873 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 11 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K091253 (K2m, Inc., 2009) has gone furthest, with 73 descendants of its own.
- 1 other device also cites its predicate K983622.
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. 2007, 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 BodyFormTM Thoracic Fixation System is intended as an adjunct to fusion for treatment of thoracic spinal instability as a result of degenerative disc disease (defined as discogenic back pain with degeneration of the: disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, and anterior fusion following failed previous fusion operations, including pseudoarthrosis.
The BodyFormT M Thoracic Fixation System is intended for unilateral use to attach to the anterolateral aspect of the vertebral bodies at levels of fixation from Ti to LI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072407 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072407: Bodyform Thoracic Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072407
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