510(k) Report

510(k) · Cleared

Cleared

Tephaflex Braided Suture

K132348510(k) TraditionalCleared Sep 5, 201338-day reviewClass II21 CFR 878.4494

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

Tepha, Inc. · NWJ Suture, Recombinant Technology

Cleared on Sep 5, 2013 as substantially equivalent to DEN060003 (Tepha, Inc., 2007) and 6 other predicates after a 38-day review. Its family tree reaches back 3 generations to 2007.

Decided
Sep 5, 2013
Review
38 days
Class
Class II
Product code
NWJ
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to DEN060003 (2007). 10 ancestors in all, the oldest K900198 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 2 other ancestors2002: 1 other ancestor1997: 1 other ancestor1993: 1 other ancestor1995: 1 other ancestor1990: 1 other ancestorDEN060003 · Tephaflex Absorbable Suture · Tepha, Inc. · 2007K122487 · Biofiber Syture · Tornier, Inc. · 2012K130422 · Phantom Fiber Biofiber Suture · Tornier, Inc. · 2013 · recalled199019952000200520102015
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors K130422 · Phantom Fiber Biofiber Suture · Tornier, Inc. · 2013 · recalledK122487 · Biofiber Syture · Tornier, Inc. · 2012DEN060003 · Tephaflex Absorbable Suture · Tepha, Inc. · 20070
  1. Root · 3 generations backDEN060003 Tephaflex Absorbable SutureTepha, Inc. · 2007
  2. 2 generations backK122487 Biofiber SytureTornier, Inc. · 2012
  3. 1 generation backK130422 Phantom Fiber Biofiber SutureTornier, Inc. · 2013 · Recalled
  4. This deviceK132348 Tephaflex Braided SutureTepha, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3DEN060003Tephaflex Absorbable SutureTepha, Inc.2007—
−2K122487Biofiber SytureTornier, Inc.2012—
−1K130422Phantom Fiber Biofiber SutureTornier, Inc.20131
0 (this device)K132348Tephaflex Braided SutureTepha, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199310
199510
199710
200210
200820
FIG. 1 — Lineage of K132348, 2007–2013Source: 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 NWJ? 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 NWJ device

  1. #1 K211307 GalaSTITCH Absorbable Monofilament Suturescore 1.4 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against? (7)

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
*DEN060003Tephaflex Absorbable Suture
Our reading of the summary gave K052225, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN060003, Tephaflex Absorbable Suture (Tepha, Inc.), granted Feb 8, 2007; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
Tepha, Inc.2007—
*K082178Tephaflex Absorbable Suture
Summary page 1
…Act, the device classification is Class 11,Performance Standards. Predicate Devices: Tepha, Inc., TephaFLEX Absorbable Suture - K(052225, K082178 Tomier, Inc., BioFiber Suture - K(122487, K(130422 Etitan, Inc.,…
Tepha, Inc.2008—
*K122487Biofiber Syture
Summary page 1
…tandards. Predicate Devices: Tepha, Inc., TephaFLEX Absorbable Suture - K(052225, K082178 Tomier, Inc., BioFiber Suture - K(122487, K(130422 Etitan, Inc., Perina-Hand Silk Braided Suture - K(930360…
Tornier, Inc.2012—
*K130422Phantom Fiber Biofiber Suture
Summary page 1
…Predicate Devices: Tepha, Inc., TephaFLEX Absorbable Suture - K(052225, K082178 Tomier, Inc., BioFiber Suture - K(122487, K(130422 Etitan, Inc., Perina-Hand Silk Braided Suture - K(930360 U.S. Sur…
Tornier, Inc.20131
*K930360Sutures
Summary page 1
…2178 Tomier, Inc., BioFiber Suture - K(122487, K(130422 Etitan, Inc., Perina-Hand Silk Braided Suture - K(930360 U.S. Surgical (Covidien), Dexon S Suture - K(972566 Ethicon, Inc.…
ETHICON, Inc.1993—
*K972566Dexon Violet
Summary page 1
…422 Etitan, Inc., Perina-Hand Silk Braided Suture - K(930360 U.S. Surgical (Covidien), Dexon S Suture - K(972566 Ethicon, Inc.. Meryl Suture - K(022269 Please see attached Subs…
Davis & Geck, Inc.1997—
*K022269Coated Vicryl* (Polyglactin 910) Suture
Summary page 1
…ded Suture - K(930360 U.S. Surgical (Covidien), Dexon S Suture - K(972566 Ethicon, Inc.. Meryl Suture - K(022269 Please see attached Substantial Equivalence table comparing th…
ETHICON, Inc.20023

Also cleared against DEN060003: 3 other devices →

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 6 years and passes through 2 companies; a new generation was cleared every 7 months on median.
  • 2 of the 10 ancestors have a recall of any class.
  • 3 other devices also cite its predicate DEN060003.

How does its category compare?

All NWJ devices

NWJ Suture, Recombinant Technology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · NWJ

1in 2021

2007: 22008: 22010: 12012: 12013: 22021: 1
2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NWJ

Too few NWJ 510(k)s in any year since 2007 to give a median.

Recalls per year · NWJ

No recall names NWJ since 2007.

Adverse event reports per year · NWJ

4in 2025

2014: 122015: 82016: 132017: 132018: 102019: 32020: 82021: 12022: 72023: 42024: 12025: 4
2007high 13 (2016) · low 0 (2007)2025

MAUDE reports naming product code NWJ, 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
20072—00
20082—00
20090—00
20101—00
20110—00
20121—00
20132—00
20140—012
20150—08
20160—013
20170—013
20180—010
20190—03
20200—08
20211—01
20220—07
20230—04
20240—01
20250—04
20260—0—

What is it indicated for?

TephaFLEX braided sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Indications for use as stated in the FDA summary.

Also cleared against DEN060003

3 other devices cite the same predicate.

  • K122487Biofiber SytureTornier, Inc. · 2012
  • K100876Aesculap Monomax Absorbable SutureAesculap, Inc. · 2010
  • K070894Tephaflex Surgical MeshTepha, Inc. · 2007

More from Tepha, Inc.

18 FDA decisions under this applicant name. See the company

  • K233999GalaFLEX LITE ScaffoldTepha, Inc. · 2024
  • K202425SurgiLattice scaffoldTepha, Inc. · 2021
  • K211307GalaSTITCH Absorbable Monofilament SutureTepha, Inc. · 2021
  • K162922GalaFORM 3DTepha, Inc. · 2017
  • K161092GalaSHAPE 3DTepha, Inc. · 20161 recall

Recent decisions in NWJ

The NWJ category page

  • K211307GalaSTITCH Absorbable Monofilament SutureTepha, Inc. · 2021
  • K130422Phantom Fiber Biofiber SutureTornier, Inc. · 20131 recall
  • K122487Biofiber SytureTornier, Inc. · 2012
  • K100876Aesculap Monomax Absorbable SutureAesculap, Inc. · 2010
  • K082178Tephaflex Absorbable SutureTepha, Inc. · 2008

https://510kreport.com/device/K132348 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132348: Tephaflex Braided Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132348

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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