510(k) · Cleared
ClearedExpedium Anterior Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 17, 2004 as substantially equivalent to K012916 (Depuy Acromed, Inc., 2001) after a 102-day review. Its family tree reaches back 2 generations to 1996. 140 later devices descend from it.
- Decided
- Aug 17, 2004
- Review
- 102 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953915 (1996). 4 ancestors in all. 140 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK953915 Moss Miami Spinal System (Anterior Use)Depuy, Inc. · 1996
- 1 generation backK012916 Frontier Anterior Scoliosis SystemDepuy Acromed, Inc. · 2001
- This deviceK041205 Expedium Anterior Spine SystemDepuy Spine, Inc. · 2004
- Descendant · cites it directly · 139 of its ownK131802 Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013
- Descendant · 2 generations on · 70 of its ownK181677 Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018
- Descendant · 3 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 61 of its ownK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · 4 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
Showing 5 of 140 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 140 · See all- K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013 · cites it directly139descendants
- K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018 · 2 generations on70descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 3 generations on69descendants
- K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 3 generations on61descendants
- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 4 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953915 | Moss Miami Spinal System (Anterior Use) | Depuy, Inc. | 1996 | — |
| −1 | K012916 | Frontier Anterior Scoliosis System | Depuy Acromed, Inc. | 2001 | — |
| 0 (this device) | K041205 | Expedium Anterior Spine System | Depuy Spine, Inc. | 2004 | — |
| +1 | K131802 | Expedium, Viper. Viper 2 Spine System | Depuy Spine, A Johnson & Johnson Company | 2013 | — |
| +2 | K181677 | Kodiak Spinal Fixation System | Alphatec Spine, Inc. | 2018 | — |
| +3 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| +3 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +4 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 12 | 0 |
| 2023 | 24 | 0 |
| 2024 | 22 | 0 |
| 2025 | 23 | 0 |
| 2026 | 20 | 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? (1)
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 |
|---|---|---|---|
| * | K012916 | Frontier Anterior Scoliosis SystemSummary page 1…nal Intervertebral Body Fixation Orthosis PROPRIETARY NAME: Expedium TM Anterior Spine System PREDICATE DEVICES: Frontier Anterior Scoliosis System (K012916) DEVICE DESCRIPTION: The Expedium Anterior Spine System consists of spinal rods, monoaxial s… | 2001 |
What descends from it? (140)
See all 1401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131802 | Expedium, Viper. Viper 2 Spine System | 2013 | 139 |
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 8 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K131802 (Depuy Spine, A Johnson & Johnson Company, 2013) has gone furthest, with 139 descendants of its own.
- 2 other devices also cite its predicate K012916.
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 Expedium Tm Anterior Spine System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The Expedium Anterior Spine System may be used in either thoracoscopic procedures or open procedures.
The Expedium Anterior Spine System is indicated for:
1. degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
2. spondylolisthesis
3. trauma (i.e., fracture or dislocation)
4. spinal stenosis
5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
6. tumor
7. pseudarthrosis
8. previous failed fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041205: Expedium Anterior Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041205
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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