510(k) · Cleared
ClearedArt Anterior Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Technologies AG · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Apr 12, 2004 as substantially equivalent to K971248 (Acromed Corp., 1997) and 1 other predicate after a 195-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Apr 12, 2004
- Review
- 195 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K873826 (1988). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873826 | Acromed/Kaneda Anterior Spinal Instrumentation | Acromed Corp. | 1988 | — |
| −1 | K971248 | Kaneda SR Anterior Spinal System | Acromed Corp. | 1997 | — |
| 0 (this device) | K033148 | Art Anterior Spinal System | Advanced Medical Technologies AG | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K971248 | Kaneda SR Anterior Spinal SystemSummary page 1…21 CFR section 888.3060) Equivalent Device The ART Anterior Spinal System is similar in material and indications as the Kaneda SR Anterior Spinal System (DePuy Acromed, K971248) and the M-2 Anterior Plate (DePuy Acromed, K972718). Device Description The ART Anterior Spinal System consists of a Plate that… | 1997 |
| * | K972718 | M-2 Anterior Plate SystemSummary page 1…Anterior Spinal System is similar in material and indications as the Kaneda SR Anterior Spinal System (DePuy Acromed, K971248) and the M-2 Anterior Plate (DePuy Acromed, K972718). Device Description The ART Anterior Spinal System consists of a Plate that attaches to the anterior or antero-lateral vertebra… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- None of the 5 ancestors has a recall.
- 6 other devices also cite its predicate K971248.
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 ART Anterior Spinal System is intended for anterolateral screw fixation of the T6-L5 spine.
Indications for use include:
· degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
* spondylolisthesis
* trauma (i.e., fracture or dislocation)
· spinal stenosis
· deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
* tumor
· pseudoarthrosis
· failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033148: Art Anterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033148
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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