510(k) · Cleared
ClearedOpus Labralock P Knotless Fixation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 14, 2006 as substantially equivalent to K042584 (Opus Medical, Inc., 2004) and 3 other predicates after a 60-day review. Its family tree reaches back 2 generations to 1992. 50 later devices descend from it.
- Decided
- Jul 14, 2006
- Review
- 60 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K921873 (1992). 10 ancestors in all. 50 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 1 generation backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- This deviceK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- Descendant · cites it directly · 27 of its ownK070227 Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007
- Descendant · cites it directly · 18 of its ownK090615 Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · Recalled
- Descendant · 2 generations on · 16 of its ownK081893 Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp. · 2008
- Descendant · 3 generations on · 15 of its ownK100457 Opus Speedscrew SystemArthrocare Corp. · 2010
- Descendant · 2 generations on · 12 of its ownK101437 Speedfix Suture SystemArthrocare Corp. · 2010
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K070227Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007 · cites it directly27descendants
- K090615Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · cites it directly18descendants
- K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp. · 2008 · 2 generations on16descendants
- K100457Opus Speedscrew SystemArthrocare Corp. · 2010 · 3 generations on15descendants
- K101437Speedfix Suture SystemArthrocare Corp. · 2010 · 2 generations on12descendants
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) | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| +1 | K070227 | Opus Magnum PI Knotless Fixation Device | Arthrocare Corp. | 2007 | — |
| +1 | K090615 | Opus Speedlock Knotless Fixation Device | Arthrocare Corp. | 2009 | 1 |
| +2 | K081893 | Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500 | Arthrocare Corp. | 2008 | — |
| +3 | K100457 | Opus Speedscrew System | Arthrocare Corp. | 2010 | — |
| +2 | K101437 | Speedfix Suture System | Arthrocare Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 7 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K042584 | Opus Minimagnum Anchor with InserterSummary page 1…Nondegradeable, Soft Tissue (Class II per 21 CFR 888.3040, Product code: MB!) Predicate Devices Opus MiniMagnum K042584 (Cleared 12/14/04) Mitek Mini QuickAnchor Plus K992487 (Cleared 09/21/99) Arthrex PEEK Pushlock KO0512 I9… | 2004 |
| * | K992487 | Mitek Mini Quickanchor PlusSummary page 1…(Class II per 21 CFR 888.3040, Product code: MB!) Predicate Devices Opus MiniMagnum K042584 (Cleared 12/14/04) Mitek Mini QuickAnchor Plus K992487 (Cleared 09/21/99) Arthrex PEEK Pushlock KO0512 I9 (Cleared 09/27/05) Mitek Bioknotless Anchor K0026 1… | 1999 |
| * | K051219 | PushlockSummary page 2…ug Administration [K042584], the Mitek Mini QuickAnchorTrm Plus [K992487], the Mitek Bioknotless'l'm Anchor [K002639] and thc Arthrex PEEKTm PushLockFm Knotless Anchor [K05 1219]. The differences between the Opus®O LabraLockVIm P and the predicate devices do not raise any questions regarding the safety and… | 2005 |
| * | K002639 | Bioknotless Anchor Our reading of the summary gave K002619, FDA’s number for Newgen System (Stryker Instruments). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Mitek Bioknotless Anchor”. | 2001 |
What descends from it? (50)
See all 504 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K070227 (Arthrocare Corp., 2007) has gone furthest, with 27 descendants of its own.
- 2 other devices also cite its predicate K042584.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 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® LabraLockTM P bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such proceditres include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus…
Read the full statement (94 words)
The Opus® LabraLockTM P bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such proceditres include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon aiiachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to arterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligamnvnt and tendon avulsions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061349: Opus Labralock P Knotless Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061349
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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