510(k) · Cleared

Cleared

Biofiber Syture

K122487510(k) TraditionalCleared Sep 17, 201233-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

Tornier, Inc. · NWJ Suture, Recombinant Technology

Cleared on Sep 17, 2012 as substantially equivalent to DEN060003 (Tepha, Inc., 2007) and 2 other predicates after a 33-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.

Decided: Sep 17, 2012
Review: 33 days
Class: Class II
Product code: NWJ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to DEN060003 (2007). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backDEN060003 Tephaflex Absorbable SutureTepha, Inc. · 2007
This deviceK122487 Biofiber SytureTornier, Inc. · 2012
Descendant · cites it directly · 1 of its ownK130422 Phantom Fiber Biofiber SutureTornier, Inc. · 2013 · Recalled
Descendant · cites it directly · 0 of its ownK132348 Tephaflex Braided SutureTepha, Inc. · 2013

Most influential descendants

Showing 2 of 2 · See all

K130422Phantom Fiber Biofiber SutureTornier, Inc. · 2013 · cites it directly1descendant
K132348Tephaflex Braided SutureTepha, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN060003	Tephaflex Absorbable Suture	Tepha, Inc.	2007	—
0 (this device)	K122487	Biofiber Syture	Tornier, Inc.	2012	—
+1	K130422	Phantom Fiber Biofiber Suture	Tornier, Inc.	2013	1
+1	K132348	Tephaflex Braided Suture	Tepha, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	2	0

FIG. 1 — Lineage of K122487, 2007–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K211307 GalaSTITCH Absorbable Monofilament Suturescore 1.4 · 1 generation · no Class I recall

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What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	DEN060003	Tephaflex 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	—
*	K081099	Tephaflex Absorbable Suture Summary page 2 …From: TephaFLEX poly(4- Feature hydroxybutyrate) suture (K052225, To: Tornier BioFiber Suture (K(122487)) ___________ K081099 & K0821 78) _______________ Indications for For use in general soft tissue…	Tepha, Inc.	2008	—
*	K082178	Tephaflex Absorbable Suture Summary page 2 …uced by Recombinant DNA Technology 5) Legally Marketed Device to which Equivalence is Claimed: TephaFLEXTh Poly(4-hydroxybutyrate) Suture: (K052225, K(081099 and K082178) 6) Comparison to Predicate Devices From: TephaFLEX poly(4- Feature hydroxybutyrate) su…	Tepha, Inc.	2008	—

Also cleared against DEN060003: 3 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130422	Phantom Fiber Biofiber Suture	Tornier, Inc.	2013	1
K132348	Tephaflex Braided Suture	Tepha, Inc.	2013	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?

None of the 3 ancestors has a recall.
Of its descendants, K130422 (Tornier, Inc., 2013) has gone furthest, with 1 descendant of its own.
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. 2012, this device’s year, is highlighted.

FDA decisions per year · NWJ

1in 2021

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	0
2008	2	—	0
2009	0	—	0
2010	1	—	0
2011	0	—	0
2012	1	—	0
2013	2	—	0
2014	0	—	12
2015	0	—	8
2016	0	—	13
2017	0	—	13
2018	0	—	10
2019	0	—	3
2020	0	—	8
2021	1	—	1
2022	0	—	7
2023	0	—	4
2024	0	—	1
2025	0	—	4
2026	0	—	—

What is it indicated for?

BioFiber Suture is 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.

https://510kreport.com/device/K122487 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122487: Biofiber Syture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122487

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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