510(k) · Cleared

Cleared

Opus MAGNUM2 Knotless Fixation Device (Model OM-1502), Opus Magnum X Knotless Fixation Device (Model OM-1503)

K081497510(k) SpecialCleared Jul 28, 200860-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

Arthrocare Corp. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jul 28, 2008 as substantially equivalent to K042914 (Opus Medical, Inc., 2004) after a 60-day review. Its family tree reaches back 2 generations to 2001.

Decided: Jul 28, 2008
Review: 60 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K012125 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK012125 Opus Magnum Anchor & InserterOpus Medical, Inc. · 2001
1 generation backK042914 Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 2004
This deviceK081497 Opus MAGNUM2 Knotless Fixation Device (Model OM-1502), Opus Magnum X…Arthrocare Corp. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K012125	Opus Magnum Anchor & Inserter	Opus Medical, Inc.	2001	—
−1	K042914	Opus Magnum Knotless Anchor with Inserter Handle	Opus Medical, Inc.	2004	—
0 (this device)	K081497	Opus MAGNUM2 Knotless Fixation Device (Model OM-1502), Opus Magnum X Knotless…	Arthrocare Corp.	2008	—

FIG. 1 — Lineage of K081497, 2001–2008Source: 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
*	K042914	Opus Magnum Knotless Anchor with Inserter Handle Summary page 1 …on, Nondegradeable, Soft Tissue (Class II per 21 CFR 888.3040, Product code: MBI) Predicate Devices Opus Magnum2 K042914 (Cleared 11/12/2004) Product Description The Opus Magnum X device is a bone anchor system with inserter handle designed for spec…	Opus Medical, Inc.	2004	—

Also cleared against K042914: 2 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 7 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K042914.

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. 2008, 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 Opus Magnum X bone anchor with inserter is indicated for use in fixation of soft tissue to bone for rotator cuff repair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081497 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081497: Opus MAGNUM2 Knotless Fixation Device (Model OM-1502), Opus Magnum X Knotless Fixation Device (Model OM-1503).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081497

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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