510(k) · Cleared

Cleared

Medicinelodge Zipknot

K051488510(k) TraditionalCleared Jul 27, 200551-day reviewClass II21 CFR 878.4300

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

Medicinelodge, Inc. · NVH Suture, Knot, Mechanical

Cleared on Jul 27, 2005 as substantially equivalent to K041216 (Smith & Nephew, Inc., 2004) after a 51-day review. Its family tree reaches back 2 generations to 2004.

Decided: Jul 27, 2005
Review: 51 days
Class: Class II
Product code: NVH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K033654 (2004). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK033654 Force FiberTeleflex Medical · 2004
1 generation backK041216 Smith & Nephew Ultrabraid SutureSmith & Nephew, Inc. · 2004
This deviceK051488 Medicinelodge ZipknotMedicinelodge, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K033654	Force Fiber	Teleflex Medical	2004	—
−1	K041216	Smith & Nephew Ultrabraid Suture	Smith & Nephew, Inc.	2004	—
0 (this device)	K051488	Medicinelodge Zipknot	Medicinelodge, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K051488, 2004–2005Source: 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 NVH? 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
*	K041216	Smith & Nephew Ultrabraid Suture Summary page 5 …le Clip Classification: 21 CFR §878.4300, Class Il Common and Usual Name: Suture Fixation Device Proprietary Name: MedicineLodge ZipKnot™ Predicate Device ULTRABRAID™ (#K041216) currently marketed by Smith & Nephew (Andover. MA). Summary This summary of 510(k) safety and effectiveness is being submitted…	Smith & Nephew, Inc.	2004	—

Also cleared against K041216: 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 1 year and passes through 3 companies; a new generation was cleared every 1.1 years on median.
None of the 3 ancestors has a recall.
3 other devices also cite its predicate K041216.

How does its category compare?

All NVH devices

NVH Suture, Knot, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NVH

FDA has decided no NVH device since 2007.

Median 510(k) review, days · NVH

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

Recalls per year · NVH

No recall names NVH since 2007.

Adverse event reports per year · NVH

No MAUDE report names NVH since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The MedicineLodge ZipKnot™ is indicated for use in approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture.

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/K051488 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051488: Medicinelodge Zipknot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051488

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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