510(k) · Cleared
ClearedArcofix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine Co.Lp · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 23, 2008 as substantially equivalent to K022791 (Synthes (Usa), 2002) after a 141-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- May 23, 2008
- Review
- 141 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022791 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK022791 Synthes Anterior Tension Band (Atb) SystemSynthes (Usa) · 2002
- This deviceK080020 ArcofixSynthes Spine Co.Lp · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022791 | Synthes Anterior Tension Band (Atb) System | Synthes (Usa) | 2002 | — |
| 0 (this device) | K080020 | Arcofix | Synthes Spine Co.Lp | 2008 | — |
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K031100 | FDA’s K031100 is Synthes Ventrofix Mis System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K022791 | Synthes Anterior Tension Band (Atb) SystemSummary page 1…Product Code: KWQ Predicates: Synthes VentroFix MIS (K311100) Synthes Anterior Tension Band (ATB3 System (K02279 1 Device The Synthes ArcoFix System is an addition to Synthes' existing Description:… | 2002 |
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?
- Its one ancestor has no recall.
- 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 Synthes ArcoFix System is indicated for use, via the lateral or anterolateral surgical approach, in the treatment of thoracic and thoracolumbar (T 1-L5) spine instability as a result of the following:
* Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
* Spondylolisthesis
* Spondylolysis
* Fracture (including dislocation and subluxation)
* Spinal stenosis
* Deformities (i.e. scoliosis, kyphosis, lordosis whether neuromuscular or related to deficient posterior elements)
* Tumors (neoplastic disease)
* Pseudoarthrosis
* Failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080020 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080020: Arcofix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080020
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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