510(k) · Cleared
ClearedArthrex SwiveLock
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 Aug 6, 2018 as substantially equivalent to K151342 (Arthrex, Inc., 2016) after a 230-day review. Its family tree reaches back 8 generations to 1997. 8 later devices descend from it.
- Decided
- Aug 6, 2018
- Review
- 230 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K971358 (1997). 30 ancestors in all, the oldest K915424 (1993). 8 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 7 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 6 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 5 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 4 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 3 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 2 generations backK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- 1 generation backK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
- This deviceK173845 Arthrex SwiveLockArthrex, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK192441 Arthrex SwiveLock AnchorsArthrex, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK251309 OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK190774 RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL…Medos International SARL · 2019
- Descendant · 3 generations on · 0 of its ownK254055 OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243726 Osprey Suture AnchorResponsive Arthroscopy, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K192441Arthrex SwiveLock AnchorsArthrex, Inc. · 2019 · cites it directly2descendants
- K251309OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2025 · 2 generations on1descendant
- K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL · 2019 · cites it directly1descendant
- K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026 · 3 generations on0descendants
- K243726Osprey Suture AnchorResponsive Arthroscopy, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −7 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −6 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −5 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −4 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −3 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −2 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| −1 | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
| 0 (this device) | K173845 | Arthrex SwiveLock | Arthrex, Inc. | 2018 | — |
| +1 | K192441 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2019 | — |
| +2 | K251309 | OSSIOfiber® Suture Anchor | OSSIO, Ltd. | 2025 | — |
| +1 | K190774 | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant | Medos International SARL | 2019 | — |
| +3 | K254055 | OSSIOfiber® Suture Anchor | OSSIO, Ltd. | 2026 | — |
| +1 | K243726 | Osprey Suture Anchor | Responsive Arthroscopy, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151342 | Arthrex SwiveLock AnchorsSummary page 4…Anchor Product Code MBI Classification Name 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device K151342: Arthrex SwiveLock Anchors Purpose of This traditional 510(k) premarket notification is submitted to obtain meniscal S… | 2016 |
| Kept off the family tree | K015342 | Arthrex SwiveLock C anchor Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (8)
5 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 21 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 30 ancestors have a recall of any class.
- Of its descendants, K192441 (Arthrex, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K151342.
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. 2018, 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 SwiveLock is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and hip in the following procedures: • Shoulder: Rotator Cuff Repairs, 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…
Read the full statement (150 words)
The Arthrex SwiveLock is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and hip in the following procedures:
• Shoulder: Rotator Cuff Repairs, 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, Bunionectomy.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75 – 5.5. SwiveLock only). Meniscal root repair (4.75 PEEK SwiveLock C only)
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173845: Arthrex SwiveLock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173845
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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