510(k) Report

510(k) · Cleared

Cleared

Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel

K143582510(k) TraditionalCleared Oct 29, 2015315-day reviewClass II21 CFR 878.5010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Resorba Medical GmbH · GAW Suture, Nonabsorbable, Synthetic, Polypropylene

Cleared on Oct 29, 2015 as substantially equivalent to K980703 (Aesculap, Inc., 1998) and 11 other predicates after a 315-day review. Its family tree reaches back 6 generations to 1996.

Decided
Oct 29, 2015
Review
315 days
Class
Class II
Product code
GAW
Recalls
None
Predicates
12

Its longest line of descent runs back 6 generations to K961555 (1996). 70 ancestors in all, the oldest K844068 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2008: 2 other ancestors2003: 3 other ancestors2002: 3 other ancestors2000: 7 other ancestors1999: 5 other ancestors1998: 5 other ancestors1996: 7 other ancestors1992: 1 other ancestor1990: 5 other ancestors2007: 2 other ancestors2006: 2 other ancestors2005: 2 other ancestors1994: 3 other ancestors1993: 3 other ancestors2004: 3 other ancestors2001: 5 other ancestors1997: 1 other ancestor1995: 2 other ancestors1987: 1 other ancestor1985: 1 other ancestorK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K071520 · Renovo Suture Anchors, Models 100-2001 Thru 100-5502X · Core Essence Orthopaedics, LLC · 2007K101126 · Pontis Sutures and Suture Anchors with Optional Crimps · Core Essence Orthopaedics, Inc. · 2010K140127 · Ferrofibre Stainless Steel Suture with Crimp · Pontis Orthopaedics, LLC · 20141985199019952000200520102015
Other ancestors, by generation 1 generation back: 11 other ancestors2 generations back: 11 other ancestors3 generations back: 17 other ancestors4 generations back: 20 other ancestors5 generations back: 5 other ancestors K140127 · Ferrofibre Stainless Steel Suture with Crimp · Pontis Orthopaedics, LLC · 2014K101126 · Pontis Sutures and Suture Anchors with Optional Crimps · Core Essence Orthopaedics, Inc. · 2010K071520 · Renovo Suture Anchors, Models 100-2001 Thru 100-5502X · Core Essence Orthopaedics, LLC · 2007K053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996−50
  1. Root · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. 4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. 3 generations backK071520 Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
  5. 2 generations backK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
  6. 1 generation backK140127 Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014
  7. This deviceK143582 Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide…Resorba Medical GmbH · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−5K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
−4K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
−3K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC2007—
−2K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.2010—
−1K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC2014—
0 (this device)K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
199050
199210
199330
199430
199520
199670
199710
199850
199950
200070
200150
200230
200330
200430
200520
200620
200720
200820
201010
FIG. 1 — Lineage of K143582, 1996–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 GAW? 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 GAW device

  1. #1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (12)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K980703Premilene Nonabsorbable Polypropylene Surgical Suture
Summary page 4
…polypropylene Aesculap, Polypropylene surgical suture K980703 RESOPREN® Non absorbable Nonabsorbable 21 CFR §878.5010 MXW II Pronova, s…
Aesculap, Inc.1998—
*K001625Pronova Nonabsorbable Suture, Usp
Summary page 4
…polypropylene Ethicon, Polyvinylidene surgical suture K001625 diflouride SILK Non absorbable Natural 21 CFR §878.5030 GAP II…
ETHICON, Inc.2000—
*K990089Silkam Nonabsorbable Silk Surgical Suture
Summary page 4
…nonabsorbable Aesculap, silk surgical K990089 suture…
Aesculap, Inc.1999—
*K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…
Summary page 4
…Medical K100006 Secondary…
Riverpoint Medical20102
*K080684WG-Surgical Sutures with Needle
Summary page 4
…supplies Inc. K080684 POLYESTER Non absorbable Nonabsorbable 21 CFR §878.5000 GAT II Cottony II,…
Foosin Medical Supplies, Inc.2008—
*K021019Cottony II, Silky II Polydek & Tevdek II Polyester Suture
Summary page 4
…poly(ethylene Tevdek terephthalate) K021019 surgical suture NYLON Non absorbable Nonabsorbable 21 CFR…
Genzyme Corp.20027
*K981582Surgilon, Dermalon, & Ophthalon
Summary page 4
…polyamide Davis&Geck, surgical suture K981582 K143582…
Davis & Geck, Inc.19989
*K913102Peters Cardionyl (TM) Suture
Summary page 5
…e: Polyamide polyamide Promedica surgical suture K913102 POLYAMIDE Non absorbable Nonabsorbable 21 CFR §878.5020 GAR II Supramid, PSEUDO suture:…
Promedica Products, Inc.1992—
*K904052Supramid Extra Sutures
Summary page 5
…: Polyamide polyamide S Jackson, surgical suture K904052 Secondary…
S. Jackson, Inc.1990—
*K955723Stainless Steel Sutures, Flexon Steel Sutures (Stainless)
Summary page 5
…Steel suture Davis&Geck, K955723 Secondary…
Davis & Geck, Inc.1996—
*K140127Ferrofibre Stainless Steel Suture with Crimp
Summary page 5
…LLC K140127 Secondary…
Pontis Orthopaedics, LLC2014—
*K030351Stainless Steel Surgical Suture, Non-Absorbable
Summary page 5
…inc. K030351 K…
Cp Medical2003—

Also cleared against K980703: 1 other device →

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 19 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
  • 14 of the 70 ancestors have a recall of any class.
  • 1 other device also cites its predicate K980703.

How does its category compare?

All GAW devices

GAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · GAW

1in 2024

2007: 12010: 22012: 32013: 32014: 22015: 32016: 12017: 32018: 32019: 12020: 22022: 22023: 12024: 12026 (partial year): 1
2007high 3 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAW

80in 2018

2012: 86 days median2013: 36 days median2015: 252 days median2017: 145 days median2018: 80 days median
2007high 252 (2015) · low 36 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GAW

2so far in 2026, the most since 2007

2007: 12026 (partial year): 2
2007high 2 (2026) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAW

2,545in 2025

2007: 732008: 752009: 712010: 852011: 842012: 1942013: 1912014: 4372015: 4222016: 4402017: 4132018: 6852019: 1,8032020: 1,4932021: 1,6522022: 1,5632023: 1,8112024: 2,3482025: 2,545
2007high 2,545 (2025) · low 71 (2009)2025

MAUDE reports naming product code GAW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—173
20080—075
20090—071
20102—085
20110—084
20123860194
20133360191
20142—0437
201532520422
20161—0440
201731450413
20183800685
20191—01,803
20202—01,493
20210—01,652
20222—01,563
20231—01,811
20241—02,348
20250—02,545
20261—2—

What is it indicated for?

Each non-absorbable suture is used as a surgical suture to support wound closure/soft tissue approximation, with the following indications:

Except Steel, each non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures*.

*MOPYLEN is also indicated for microsurgery

* POLYESTER is also indicated for orthopaedic surgery

*RESOLON is also indicated for microsurgery

Steel wire is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K980703

1 other device cites the same predicate.

  • K133890Aesculap Optilene Nonabsorbable SutureAesculap, Inc. · 2014

More from Resorba Medical GmbH

4 FDA decisions under this applicant name. See the company

  • K181320CaprolonResorba Medical GmbH · 2018
  • K143584Pga Resorba, Pga Resoquick, GlycolonResorba Medical GmbH · 2015
  • K141072SupoleneResorba Medical GmbH · 2014

Recent decisions in GAW

The GAW category page

  • K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™…ETHICON, Inc. · 2026
  • K233355Cypris eXact Suturing SystemCypris Medical · 2024
  • K230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd. · 2023
  • K221280VessealLydus Medical, Ltd. · 2022
  • K211178DURAMESH Mesh SutureMsi · 2022

https://510kreport.com/device/K143582 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143582: Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143582

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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