510(k) · Cleared

Cleared

TruShot with Y-Knot Shallow All-Suture Anchor

K182439510(k) TraditionalCleared Jan 8, 2019123-day reviewClass II21 CFR 888.3040

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

Conmed Corporation · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jan 8, 2019 as substantially equivalent to K992487 (Mitek Products, 1999) after a 123-day review. Its family tree reaches back 2 generations to 1992.

Decided: Jan 8, 2019
Review: 123 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K921873 (1992). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
1 generation backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
This deviceK182439 TruShot with Y-Knot Shallow All-Suture AnchorConmed Corporation · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K921873	Quickanchor, Modification	Mitek Surgical Products, Inc.	1992	—
−1	K992487	Mitek Mini Quickanchor Plus	Mitek Products	1999	—
0 (this device)	K182439	TruShot with Y-Knot Shallow All-Suture Anchor	Conmed Corporation	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	1	0

FIG. 1 — Lineage of K182439, 1992–2019Source: 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 MBI? 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 MBI device

#1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K992487	Mitek Mini Quickanchor Plus Summary page 4 …s: Class II, per 21 CFR Part 888. 3040 Product Codes: MBI PREDICATE/ LEGALLY MARKETED DEVICE Device Name: Mitek Mini QuickAnchor® Plus Company Name: Mitek 510(k) #: K992487 REFERENCE DEVICE Device Name: ConMed Linvatec Y-Knot™ All-Suture Anchor Company Name: ConMed Linvatec 510(k) #: K111779 ADDIT…	Mitek Products	1999	—
†	K111779	Y-Knot All-Suture Anchor Model HF13	Conmed Linvatec	2011	—
†	K131035	Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM	Linvatec Corporation D/B/A Conmed Linvatec	2013	—

Also cleared against K992487: 7 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 27 years and passes through 3 companies; a new generation was cleared every 19.3 years on median.
None of the 4 ancestors has a recall.
7 other devices also cite its predicate K992487.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007high 3,826 (2025) · low 240 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	80	24	240
2008	10	69	6	338
2009	19	82	2	355
2010	17	76	3	291
2011	30	75	23	328
2012	24	94	6	371
2013	31	100	2	442
2014	23	101	0	504
2015	23	85	0	507
2016	17	94	0	795
2017	17	70	4	675
2018	16	91	2	1,072
2019	31	90	0	1,303
2020	35	83	1	1,454
2021	18	107	0	1,890
2022	19	64	0	1,591
2023	52	57	1	2,503
2024	22	30	1	3,779
2025	27	58	1	3,826
2026	30	63	0	—

What is it indicated for?

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

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/K182439 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182439: TruShot with Y-Knot Shallow All-Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182439

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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