510(k) · Cleared
ClearedAuxilock Titanium Screw-In Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auxein Medical Private Limited · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 29, 2022 as substantially equivalent to K152566 (Smith & Nephew, Inc., 2015) and 1 other predicate after a 308-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Jul 29, 2022
- Review
- 308 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K961555 (1996). 43 ancestors in all, the oldest K941364 (1994). No later device cites it as a predicate yet.
- Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations between
- 3 generations backK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
- 2 generations backK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
- 1 generation backK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
- This deviceK213104 Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited · 2022
Show all 10 generations
- Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 9 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 8 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 7 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 6 generations backK070908 Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007
- 5 generations backK072785 Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007
- 4 generations backK093228 Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009
- 3 generations backK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
- 2 generations backK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
- 1 generation backK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
- This deviceK213104 Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −9 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −8 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −7 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −6 | K070908 | Smith & Nephew Kinsa RC Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | — |
| −5 | K072785 | Twinfix FT PK | Smith & Nephew Inc., Endoscopy Division | 2007 | — |
| −4 | K093228 | Smith & Nephew Twinfix Ultra PK Suture Anchor | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100159 | Smith and Nephew Twinfix Ultra TI Suture Anchor | Smith & Nephew Inc., Endoscopy Div. | 2010 | 4 |
| −2 | K112526 | Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors | Smith & Nephew, Inc. | 2012 | — |
| −1 | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01… | Smith & Nephew, Inc. | 2015 | 2 |
| 0 (this device) | K213104 | Auxilock Titanium Screw-In Suture Anchor | Auxein Medical Private Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Summary page 5…are declaring substantial equivalence: The following is the range of variants covered with their corresponding predicate devices. Primary Predicate: 510(k) Number K152566 Applicant Smith & Nephew Common Name Suture Anchor Device Name PEBA Anchor/Suture Combination Secondar… | 2015 |
| * | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSummary page 5…K152566 Applicant Smith & Nephew Common Name Suture Anchor Device Name PEBA Anchor/Suture Combination Secondary Predicate: 510(k) Number K053344 Applicant Smith & Nephew Common Name Suture Anchor Device Name TwinFix 2.8mm, 3.5mm and BioRaptor 2.9mm… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 10 of the 43 ancestors have a recall of any class.
- 5 other devices also cite its predicate K152566.
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. 2022, 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 Auxilock Titanium Screw-In Suture Anchor is intended to be used with #2 Biobraid suture with white, blue, black colors for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsutolabral reconstructions, Biceps tenodesis, and Deltoid Repairs, Anterior Shoulder Instability Repair. Foot…
Read the full statement (135 words)
The Auxilock Titanium Screw-In Suture Anchor is intended to be used with #2 Biobraid suture with white, blue, black colors for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsutolabral reconstructions, Biceps tenodesis, and Deltoid Repairs, Anterior Shoulder Instability Repair.
Foot and Ankle:
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy.
Elbow, Wrist and Hand:
Scapholunate ligament reconstruction, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment, Tennis elbow repair.
Knee:
Extra-capsular repairs: Medial collateral ligament repair, Lateral collateral ligament repair, Posterior oblique ligament, Iliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement.
Hip:
Capsular repair, Acetabular labral repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213104: Auxilock Titanium Screw-In Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213104
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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