510(k) · Cleared
ClearedICONN Square 2.5MM Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iconn Orthopedics, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Nov 29, 2017 as substantially equivalent to K121018 (Smith & Nephew, Inc., 2012) and 2 other predicates after a 104-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Nov 29, 2017
- Review
- 104 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K961555 (1996). 18 ancestors in all. No later device cites it as a predicate yet.
- 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 backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 3 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 2 generations backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
- 1 generation backK121018 Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless…Smith & Nephew, Inc. · 2012
- This deviceK172491 ICONN Square 2.5MM Suture AnchorIconn Orthopedics, LLC · 2017
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 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −3 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −2 | K082215 | Osteoraptor Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2008 | 9 |
| −1 | K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K172491 | ICONN Square 2.5MM Suture Anchor | Iconn Orthopedics, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSummary page 5…The predicate devices are: Smith & Nephew, Inc. BIORAPTOR 2.3PK Suture Anchor, Model 72201542 (K121018) Arthrex 2.9mm Short PEEK Pushlock Suture Anchor, Model Number AR-2923PS (K06… | 2012 |
| * | K063479 | Arthrex PushlockSummary page 5…Model 72201542 (K121018) Arthrex 2.9mm Short PEEK Pushlock Suture Anchor, Model Number AR-2923PS (K063479) Both predicates are intended for soft tissue fixation to bone for the same indication… | 2006 |
| * | K132724 | Iconn Answer Suture AnchorSummary page 5…knotted configuration and 2.9mm Short PEEK Pushlock for the knotless configuration). As well, the ICONN Answer Suture Anchor (K132724) was used as a predicate device to demonstrate substantial equivalence as it relates to… | 2014 |
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 21 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 18 ancestors have a recall of any class.
- 8 other devices also cite its predicate K121018.
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. 2017, 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 ICONN Square Suture Anchor System is intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The system is designed for use in the hip, shoulder, foot, ankle, elbow, wrist, hand, and knee for the following indications: Hip Indications: Capsule Repair, Acetabular Labrum Reattachment Shoulder Indications: Capsular Stabilization, Bankart Repair, Anterior…
Read the full statement (147 words)
The ICONN Square Suture Anchor System is intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The system is designed for use in the hip, shoulder, foot, ankle, elbow, wrist, hand, and knee for the following indications:
Hip Indications: Capsule Repair, Acetabular Labrum Reattachment
Shoulder Indications: Capsular Stabilization, Bankart Repair, Anterior Shoulder Instability, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Acromioclavicular Separation Repair, Deltoid Repair, Rotator Cuff Repair, Biceps Tenodesis.
Foot/Ankle Indications: Hallux Valgus Repair, Medial or Lateral Instability Repair/Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair/Reconstruction, Bunionectomy.
Elbow, Wrist, and Hand: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Knee: Extra Capsular Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Patellar Realignment and Tendon Repair, Vastus Medialis Obliquous Advancement, Iliotibial Band Tenodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172491: ICONN Square 2.5MM 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/K172491
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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