510(k) · Cleared
ClearedSpeedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown Tip Speedlock Hip Pathfinder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ArthroCare Corporation · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Sep 21, 2012 as substantially equivalent to K071586 (Smith & Nephew Inc., Endoscopy Division, 2007) and 2 other predicates after a 176-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Sep 21, 2012
- Review
- 176 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K961555 (1996). 22 ancestors in all, the oldest K921873 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 3 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 2 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 1 generation backK093428 Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009
- This deviceK120943 Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill…ArthroCare Corporation · 2012
- Descendant · cites it directly · 0 of its ownK123240 Speedlock Hip Knotless Fixation ImplantArthroCare Corporation · 2013
Most influential descendants
Showing 1 of 1 · See all- K123240Speedlock Hip Knotless Fixation ImplantArthroCare Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −5 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −4 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −3 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −2 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −1 | K093428 | Smith & Nephew Knotless Instability Anchor | Smith & Nephew Endoscopy, Inc. | 2009 | — |
| 0 (this device) | K120943 | Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip… | ArthroCare Corporation | 2012 | — |
| +1 | K123240 | Speedlock Hip Knotless Fixation Implant | ArthroCare Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (3)
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 |
|---|---|---|---|
| * | K071586 | Bioraptor 2.3 PK Suture AnchorSummary page 1…____________________ The SpeedLock HIP Knotless Fixation Implant is substantially equivalent to the Smith & Nephew Bioraptor® Knotless Suture Anchor cleared under K07 1586 (August 17. 2007) and the Smith & Nephew Knotless Instability Anchor cleared under K093428 (December 17, 2009) as well as to Ar… | 2007 |
| * | K093428 | Smith & Nephew Knotless Instability AnchorSummary page 1…ent to the Smith & Nephew Bioraptor® Knotless Suture Anchor cleared under K07 1586 (August 17. 2007) and the Smith & Nephew Knotless Instability Anchor cleared under K093428 (December 17, 2009) as well as to ArthroCare's SpeedLock Knotless Fixation Device cleared under KI 111044 (August 9, 2011).… | 2009 |
| * | K111044 | Speedlock Knotless Fixation Device; 3.0MM Drill; Sharp Tipped Obturator; Low Profile…Summary page 1…e Smith & Nephew Knotless Instability Anchor cleared under K093428 (December 17, 2009) as well as to ArthroCare's SpeedLock Knotless Fixation Device cleared under KI 111044 (August 9, 2011). Description The SpeedLock HIP Knotless Fixation Implant (SpeedLock HIP) is a bone anchor with inserter han… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123240 | Speedlock Hip Knotless Fixation Implant | 2013 | 0 |
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 16 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 22 ancestors have a recall of any class.
- Of its descendants, K123240 (ArthroCare Corporation, 2013) has gone furthest, with 0 descendants of its own.
- 22 other devices also cite its predicate K071586.
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. 2012, 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 SpeedLock HIP Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone in the hip. Examples of such procedures include:
Hip capsule repair
Acetabular labrum reattachment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120943 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120943: Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown Tip Speedlock Hip Pathfinder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120943
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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