510(k) · Cleared
ClearedFerrofibre Stainless Steel Suture with Crimp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pontis Orthopaedics, LLC · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Cleared on May 28, 2014 as substantially equivalent to K081060 (Core Essence Orthopaedics, LLC, 2008) and 1 other predicate after a 132-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- May 28, 2014
- Review
- 132 days
- Class
- Class II
- Product code
- GAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K961555 (1996). 29 ancestors in all, the oldest K844068 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 2 generations backK071520 Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
- 1 generation backK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
- This deviceK140127 Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014
- Descendant · cites it directly · 0 of its ownK143582 Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide…Resorba Medical GmbH · 2015
Most influential descendants
Showing 1 of 1 · See all- K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −4 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −3 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −2 | K071520 | Renovo Suture Anchors, Models 100-2001 Thru 100-5502X | Core Essence Orthopaedics, LLC | 2007 | — |
| −1 | K101126 | Pontis Sutures and Suture Anchors with Optional Crimps | Core Essence Orthopaedics, Inc. | 2010 | — |
| 0 (this device) | K140127 | Ferrofibre Stainless Steel Suture with Crimp | Pontis Orthopaedics, LLC | 2014 | — |
| +1 | K143582 | Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel | Resorba Medical GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K081060 | Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5Summary page 1…Stainless Steel Suture Section §C.F.R. Section 878.4495 Product Code A Predicate Device(s) ferrol'ibrerM (K08 1060) Device Description The ferroFibreTm with Crimp is a nonabsorbable sterile surgical suture… | 2008 |
| * | K101126 | Pontis Sutures and Suture Anchors with Optional CrimpsSummary page 1…added to provide an alternate to knot tying. The use of the crimp for size 3-0 and 4-0 was cleared under submission K 101126. Reason for 510(k) Device Modification - To allow the use of a crimp for securing size 3-… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143582 | Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel | 2015 | 0 |
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 18 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K143582 (Resorba Medical GmbH, 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K081060.
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. 2014, 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?
ferroFlBRETM Stainless Steel Suture are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerciage and tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140127 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140127: Ferrofibre Stainless Steel Suture with Crimp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140127
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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