510(k) · Cleared
ClearedStryker ICONIX with Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 29, 2015 as substantially equivalent to K133671 (Stryker Corp., 2014) and 1 other predicate after a 55-day review. Its family tree reaches back 9 generations to 1996. 10 later devices descend from it.
- Decided
- Jun 29, 2015
- Review
- 55 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K961555 (1996). 26 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations between
- 3 generations backK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- 2 generations backK110545 Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor…Smith & Nephew, Inc. · 2011
- 1 generation backK133671 Iconix All Suture AnchorsStryker Corp. · 2014
- This deviceK151201 Stryker ICONIX with NeedlesStryker · 2015
- Descendant · cites it directly · 5 of its ownK173074 ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker · 2018
- Descendant · 2 generations on · 3 of its ownK231078 All-Suture AnchorRiverpoint Medical, LLC · 2023
- Descendant · cites it directly · 3 of its ownK231278 Knotless Suture AnchorRiverpoint Medical, LLC · 2023 · Recalled
- Descendant · 3 generations on · 1 of its ownK233468 Iconix AnchorRiverpoint Medical · 2023
- Descendant · 2 generations on · 0 of its ownK262677 Iconix Knotless TRiverpoint Medical · 2026
Show all 9 generations
- Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 8 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 7 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 6 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 5 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 4 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- 3 generations backK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- 2 generations backK110545 Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor…Smith & Nephew, Inc. · 2011
- 1 generation backK133671 Iconix All Suture AnchorsStryker Corp. · 2014
- This deviceK151201 Stryker ICONIX with NeedlesStryker · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker · 2018 · cites it directly5descendants
- K231078All-Suture AnchorRiverpoint Medical, LLC · 2023 · 2 generations on3descendants
- K231278Knotless Suture AnchorRiverpoint Medical, LLC · 2023 · cites it directly3descendants
- K233468Iconix AnchorRiverpoint Medical · 2023 · 3 generations on1descendant
- K262677Iconix Knotless TRiverpoint Medical · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −8 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −7 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −6 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −5 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −4 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| −3 | K101823 | Arthrex Swivelock Anchors | Arthrex, Inc. | 2011 | 6 |
| −2 | K110545 | Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK) | Smith & Nephew, Inc. | 2011 | — |
| −1 | K133671 | Iconix All Suture Anchors | Stryker Corp. | 2014 | — |
| 0 (this device) | K151201 | Stryker ICONIX with Needles | Stryker | 2015 | — |
| +1 | K173074 | ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor | Stryker | 2018 | — |
| +2 | K231078 | All-Suture Anchor | Riverpoint Medical, LLC | 2023 | — |
| +1 | K231278 | Knotless Suture Anchor | Riverpoint Medical, LLC | 2023 | 1 |
| +3 | K233468 | Iconix Anchor | Riverpoint Medical | 2023 | — |
| +2 | K262677 | Iconix Knotless T | Riverpoint Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133671 | Iconix All Suture AnchorsSummary page 4…888.3040) Regulatory Class: II Product Code: MBI III. PREDICATE DEVICES Predicate A (Primary Predicate): Stryker ICONIX All Suture Anchors, K133671 This predicate has not been subject to a design-related recall. Predicate B: Stryker PEEK and Titanium Soft Eyelet Anchors, K071… | 2014 |
| * | K071157 | Stryker Peek and Titanium Soft Eyelet AnchorsSummary page 4…: Stryker ICONIX All Suture Anchors, K133671 This predicate has not been subject to a design-related recall. Predicate B: Stryker PEEK and Titanium Soft Eyelet Anchors, K071157 This predicate has not been subject to a design-related recall regarding the components of interest. IV. DEVICE DESCRIPTION I… | 2007 |
What descends from it? (10)
3 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 5 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 26 ancestors have a recall of any class.
- Of its descendants, K173074 (Stryker, 2018) has gone furthest, with 5 descendants of its own.
- 7 other devices also cite its predicate K133671.
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 Stryker ICONIX with Needles Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, wrist, elbow, and shoulder. See indications below. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair Hand/Wrist…
Read the full statement (137 words)
The Stryker ICONIX with Needles Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, wrist, elbow, and shoulder. See indications below.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction,
Repair/Reconstruction of Collateral Ligaments, Repair of Flexor And Extensor Tendons at the PIP, DIP, and MCP Joint for All Digits, Digital Tendon Repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151201: Stryker ICONIX with Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151201
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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