510(k) · Cleared
Recalled · 2010Opus Speedlock 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 Jun 3, 2009 as substantially equivalent to K061349 (Arthrocare Corp., 2006) after an 86-day review. Its family tree reaches back 3 generations to 1992. 18 later devices descend from it. It has been recalled once.
- Decided
- Jun 3, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921873 (1992). 11 ancestors in all. 18 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 2 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- 1 generation backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- This deviceK090615 Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009
- Descendant · cites it directly · 12 of its ownK101437 Speedfix Suture SystemArthrocare Corp. · 2010
- Descendant · 2 generations on · 10 of its ownK112453 Sterispineps Pedicle ScrewSafe Orthopaedics · 2011
- Descendant · 3 generations on · 6 of its ownK121299 Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics · 2012
- Descendant · 3 generations on · 5 of its ownK130632 Sterispine PS Pedicle ScrewSafe Orthopaedics · 2013
- Descendant · 3 generations on · 4 of its ownK150092 STERISPINE PS Pedicle ScrewSafe Orthopaedics · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K101437Speedfix Suture SystemArthrocare Corp. · 2010 · cites it directly12descendants
- K112453Sterispineps Pedicle ScrewSafe Orthopaedics · 2011 · 2 generations on10descendants
- K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics · 2012 · 3 generations on6descendants
- K130632Sterispine PS Pedicle ScrewSafe Orthopaedics · 2013 · 3 generations on5descendants
- K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −2 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| −1 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| 0 (this device) | K090615 | Opus Speedlock Knotless Fixation Device | Arthrocare Corp. | 2009 | — |
| +1 | K101437 | Speedfix Suture System | Arthrocare Corp. | 2010 | — |
| +2 | K112453 | Sterispineps Pedicle Screw | Safe Orthopaedics | 2011 | — |
| +3 | K121299 | Sterispineps Pedicle Screw, Sterispineps Rod | Safe Orthopaedics | 2012 | — |
| +3 | K130632 | Sterispine PS Pedicle Screw | Safe Orthopaedics | 2013 | — |
| +3 | K150092 | STERISPINE PS Pedicle Screw | Safe Orthopaedics | 2015 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 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? (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 | Decided |
|---|---|---|---|
| * | K061349 | Opus Labralock P Knotless Fixation DeviceSummary page 1…ndegradeable, Soft Tissue (Class II per 21 CFR 888.3040, Product code: MBI) Predicate Devices Opus LabraLockTM P K061349 (Cleared July 14, 2006) Knotless Fixation Device Product Description The Opus SpeedLock Knotless Fixation Device is a bone ancho… | 2006 |
What descends from it? (18)
See all 182 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2010 | Not classified | Z-1952-2011 | Process control | During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K101437 (Arthrocare Corp., 2010) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K061349.
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. 2009, this device’s year, is highlighted.
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 SpeedLock Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures 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 (92 words)
The Opus SpeedLock Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures 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 attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090615: Opus Speedlock Knotless Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090615
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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