510(k) · Cleared
ClearedFerrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Core Essence Orthopaedics, LLC · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Cleared on Dec 24, 2008 after a 254-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Dec 24, 2008
- Review
- 254 days
- Class
- Class II
- Product code
- GAQ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK081060 Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0…Core Essence Orthopaedics, LLC · 2008
- Descendant · cites it directly · 3 of its ownK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK140127 Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK143582 Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide…Resorba Medical GmbH · 2015
- Descendant · 2 generations on · 0 of its ownK141711 Pontis 3MM Suture Anchors with Ultra-High Molecular Weight…Pontis Orthopaeeics, LLC · 2014
- Descendant · cites it directly · 0 of its ownK133579 Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC · 2014
Most influential descendants
Showing 5 of 5 · See all- K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010 · cites it directly3descendants
- K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014 · cites it directly1descendant
- K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH · 2015 · 2 generations on0descendants
- K141711Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…Pontis Orthopaeeics, LLC · 2014 · 2 generations on0descendants
- K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081060 | Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5 | Core Essence Orthopaedics, LLC | 2008 | — |
| +1 | K101126 | Pontis Sutures and Suture Anchors with Optional Crimps | Core Essence Orthopaedics, Inc. | 2010 | — |
| +1 | K140127 | Ferrofibre Stainless Steel Suture with Crimp | Pontis Orthopaedics, LLC | 2014 | — |
| +2 | K143582 | Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel | Resorba Medical GmbH | 2015 | — |
| +2 | K141711 | Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene… | Pontis Orthopaeeics, LLC | 2014 | — |
| +1 | K133579 | Multifilament Stainless Steel Sutures with Crimps | Pontis Orthopaedics, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 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 GAQ? 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 GAQ device
- #1 K203855 CoNextions TR Tendon Repair Systemscore 3.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (5)
3 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, K101126 (Core Essence Orthopaedics, Inc., 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GAQ devicesGAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GAQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GAQ
Too few GAQ 510(k)s in any year since 2007 to give a median.
Recalls per year · GAQ
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAQ
83in 2025
MAUDE reports naming product code GAQ, 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 | 1 | — | 0 | 7 |
| 2008 | 2 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 2 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 17 |
| 2016 | 0 | — | 0 | 23 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 1 | — | 0 | 52 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 70 |
| 2023 | 0 | — | 0 | 100 |
| 2024 | 0 | — | 0 | 176 |
| 2025 | 0 | — | 0 | 83 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
ferroFibre TM Stainless Steel Sutures are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081060: Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081060
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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