510(k) · Cleared
ClearedArthrex Biowire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · GAS Suture, Nonabsorbable, Synthetic, Polyester
Cleared on Jul 30, 2010 after a 477-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jul 30, 2010
- Review
- 477 days
- Class
- Class II
- Product code
- GAS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK091018 Arthrex BiowireArthrex, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK112899 Arthrex Bio-SutureArthrex, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK140019 Arthrex BiosutureArthrex, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK223822 Activbraid™Embody, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK220880 Arthrex BioSutureArthrex, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091018 | Arthrex Biowire | Arthrex, Inc. | 2010 | — |
| +1 | K112899 | Arthrex Bio-Suture | Arthrex, Inc. | 2012 | — |
| +2 | K140019 | Arthrex Biosuture | Arthrex, Inc. | 2014 | — |
| +2 | K223822 | Activbraid™ | Embody, Inc. | 2023 | — |
| +2 | K220880 | Arthrex BioSuture | Arthrex, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAS? 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 GAS device
- #1 K203081 RAM COR-SUTURE QUCIK LOAD Surgical Suture…score 1.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112899 | Arthrex Bio-Suture | 2012 | 3 |
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, K112899 (Arthrex, Inc., 2012) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GAS devicesGAS Suture, Nonabsorbable, Synthetic, Polyester: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GAS
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GAS
Too few GAS 510(k)s in any year since 2007 to give a median.
Recalls per year · GAS
No recall names GAS since 2007.
Adverse event reports per year · GAS
3in 2025
MAUDE reports naming product code GAS, 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 | 0 | — | 0 | 35 |
| 2008 | 0 | — | 0 | 47 |
| 2009 | 0 | — | 0 | 56 |
| 2010 | 1 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 25 |
| 2012 | 0 | — | 0 | 73 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K091018 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091018: Arthrex Biowire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091018
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026