510(k) · Cleared

Cleared

GalaSTITCH Absorbable Monofilament Suture

K211307510(k) SpecialCleared May 27, 202128-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 May 27, 2021 as substantially equivalent to K082178 (Tepha, Inc., 2008) after a 28-day review. Its family tree reaches back 1 generation to 2008.

Decided: May 27, 2021
Review: 28 days
Class: Class II
Product code: NWJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K082178 (2008). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK082178 Tephaflex Absorbable SutureTepha, Inc. · 2008
This deviceK211307 GalaSTITCH Absorbable Monofilament SutureTepha, Inc. · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K082178	Tephaflex Absorbable Suture	Tepha, Inc.	2008	—
0 (this device)	K211307	GalaSTITCH Absorbable Monofilament Suture	Tepha, Inc.	2021	—

FIG. 1 — Lineage of K211307, 2008–2021Source: 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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

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
*	K082178	Tephaflex Absorbable Suture Summary page 4 …Code: NWJ 3. Predicate Device Predicate Name/510(k) Number TephaFLEX™ Absorbable Monofilament Suture (K082178) Reference Devices: Stratafix Spiral PDS Plus (K192144) Maxon Monofilament…	Tepha, Inc.	2008	—
†	K192144	STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device	ETHICON, Inc.	2020	1
†	K990951	Maxon** Sterile, Synthetic, Absorbable Suture	United States Surgical, A Division of Tyco Healthc	1999	1

Also cleared against K082178: 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?

Its one ancestor has no recall.
3 other devices also cite its predicate K082178.

How does its category compare?

All NWJ devices

NWJ Suture, Recombinant Technology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?

GalaSTITCH™ Absorbable Monofilament 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K211307 · printed Nov 6, 2026

Cite this page

510(k) Report. “K211307: GalaSTITCH Absorbable Monofilament Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211307

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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