510(k) · Cleared
ClearedBodyform Thoraco-Lumbar Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Surgical,Llc · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Dec 30, 1998 after a 76-day review. The FDA summary names its predicate without a number. 328 later devices descend from it.
- Decided
- Dec 30, 1998
- Review
- 76 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
328 later devices descend from it, 2 citing it directly.
- This deviceK983622 Bodyform Thoraco-Lumbar Fixation SystemTheken Surgical,Llc · 1998
- Descendant · cites it directly · 254 of its ownK002824 Macs Modular Anterior Construct SystemAesculap, Inc. · 2001
- Descendant · 2 generations on · 250 of its ownK032059 Modification to Macs Modular Anterior Construct SystemAesculap, Inc. · 2003
- Descendant · 3 generations on · 248 of its ownK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
- Descendant · 4 generations on · 218 of its ownK102249 Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010
- Descendant · 4 generations on · 203 of its ownK111571 Viper SystemsJohnson & Johnson · 2011
Showing 5 of 328 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 328 · See all- K002824Macs Modular Anterior Construct SystemAesculap, Inc. · 2001 · cites it directly254descendants
- K032059Modification to Macs Modular Anterior Construct SystemAesculap, Inc. · 2003 · 2 generations on250descendants
- K070387Expedium Spine SystemDepuy Spine, Inc. · 2007 · 3 generations on248descendants
- K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010 · 4 generations on218descendants
- K111571Viper SystemsJohnson & Johnson · 2011 · 4 generations on203descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983622 | Bodyform Thoraco-Lumbar Fixation System | Theken Surgical,Llc | 1998 | — |
| +1 | K002824 | Macs Modular Anterior Construct System | Aesculap, Inc. | 2001 | — |
| +2 | K032059 | Modification to Macs Modular Anterior Construct System | Aesculap, Inc. | 2003 | — |
| +3 | K070387 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| +4 | K102249 | Expedium Spine System | Depuy Spine, A Johnson & Johnson Company | 2010 | — |
| +4 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 14 | 0 |
| 2014 | 12 | 0 |
| 2015 | 13 | 0 |
| 2016 | 11 | 0 |
| 2017 | 8 | 0 |
| 2018 | 21 | 0 |
| 2019 | 17 | 0 |
| 2020 | 19 | 0 |
| 2021 | 15 | 0 |
| 2022 | 28 | 0 |
| 2023 | 41 | 0 |
| 2024 | 38 | 0 |
| 2025 | 39 | 0 |
| 2026 | 35 | 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 |
|---|---|---|---|
| * | — | Z-Plate Anterior Fixation System (Sofamor-Danek) Named without a submission number | |
| * | — | University Plate Titanium Anterior System (Acromed) Named without a submission number | |
| * | — | Anterior Thoracolumbar Locking Plate (Synthes) Named without a submission number |
What descends from it? (328)
See all 3282 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?
- Of its descendants, K002824 (Aesculap, Inc., 2001) has gone furthest, with 254 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 BodyForm Thoraco-Lumbar Fixation System is intended for treatment of anterior thoraco-lumbar spinal instability caused by:
1. Trauma.
2. Tumor,
3. Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
4, Aaterior fusion following multiple failed posterior fusion operations, including pseudoarthrosis.
The instrumentation is designed for leveis of fixation from T10 to L4.
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/K983622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983622: Bodyform Thoraco-Lumbar Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983622
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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