510(k) · Cleared
ClearedArthrex Corkscrew and SwiveLock Suture Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 2, 2015 as substantially equivalent to K113294 (Smith & Nephew, Inc., 2012) and 2 other predicates after a 183-day review. Its family tree reaches back 7 generations to 1996. 10 later devices descend from it.
- Decided
- Jul 2, 2015
- Review
- 183 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K961555 (1996). 10 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 4 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 3 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 2 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- 1 generation backK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- This deviceK143745 Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK180951 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019
- Descendant · cites it directly · 2 of its ownK202763 Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK231322 Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK222763 Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK202153 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019 · cites it directly4descendants
- K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd. · 2021 · cites it directly2descendants
- K231322Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd. · 2023 · 2 generations on1descendant
- K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC · 2022 · 2 generations on1descendant
- K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −6 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −5 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −4 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −3 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −2 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| −1 | K101823 | Arthrex Swivelock Anchors | Arthrex, Inc. | 2011 | 6 |
| 0 (this device) | K143745 | Arthrex Corkscrew and SwiveLock Suture Anchors | Arthrex, Inc. | 2015 | — |
| +1 | K180951 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2019 | — |
| +1 | K202763 | Fix2Lock (PEEK Self Punching) | Osteonic Co., Ltd. | 2021 | — |
| +2 | K231322 | Fix2Lock (PEEK Self Punching) | Osteonic Co., Ltd. | 2023 | — |
| +2 | K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors | Responsive Arthroscopy, LLC | 2022 | — |
| +2 | K202153 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K113294 | Smith & Nephew Healicoil PK Suture AnchorSummary page 5…chor Product Code, MBI Classification Name, CFR 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Predicate Device K113294: HEALICOIL PK Suture Anchor K101823: Arthrex SwiveLock Anchors K061… | 2012 |
| * | K101823 | Arthrex Swivelock AnchorsSummary page 5…21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Predicate Device K113294: HEALICOIL PK Suture Anchor K101823: Arthrex SwiveLock Anchors K061863: Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio Corksc… | 2011 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 5…tener Predicate Device K113294: HEALICOIL PK Suture Anchor K101823: Arthrex SwiveLock Anchors K061863: Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio Corkscrew FT Suture Anchors Purpose… | 2006 |
What descends from it? (10)
4 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 19 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K180951 (Responsive Arthroscopy, LLC, 2019) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K113294.
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. 2015, 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 Arthrex Corkscrew suture anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon…
Read the full statement (252 words)
The Arthrex Corkscrew suture anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder,
foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation
Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot
Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,
Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral
Epicondylitis repair.
Hip: Capsular repair, acetabular labral repair, gluteus medius repair.
The Arthrex SwiveLock anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee,
hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation
Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot
Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique
Ligament Repair, and Illiotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral
Epicondylitis repair.
Hip: Capsular repair, acetabular labral repair, gluteus medius repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143745: Arthrex Corkscrew and SwiveLock Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143745
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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