510(k) · Cleared
ClearedStryker All Suture Anchors
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 Jul 26, 2012 as substantially equivalent to K070882 (Stryker Endoscopy, 2007) after a 156-day review. Its family tree reaches back 5 generations to 1996. 27 later devices descend from it.
- Decided
- Jul 26, 2012
- Review
- 156 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K961555 (1996). 12 ancestors in all. 27 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 2 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 1 generation backK070882 Stryker Peek Twinloop TacStryker Endoscopy · 2007
- This deviceK120509 Stryker All Suture AnchorsStryker · 2012
- Descendant · cites it directly · 25 of its ownK133671 Iconix All Suture AnchorsStryker Corp. · 2014
- Descendant · 2 generations on · 10 of its ownK151201 Stryker ICONIX with NeedlesStryker · 2015
- Descendant · 3 generations on · 5 of its ownK173074 ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker · 2018
- Descendant · 4 generations on · 3 of its ownK231078 All-Suture AnchorRiverpoint Medical, LLC · 2023
- Descendant · 3 generations on · 3 of its ownK231278 Knotless Suture AnchorRiverpoint Medical, LLC · 2023 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K133671Iconix All Suture AnchorsStryker Corp. · 2014 · cites it directly25descendants
- K151201Stryker ICONIX with NeedlesStryker · 2015 · 2 generations on10descendants
- K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker · 2018 · 3 generations on5descendants
- K231078All-Suture AnchorRiverpoint Medical, LLC · 2023 · 4 generations on3descendants
- K231278Knotless Suture AnchorRiverpoint Medical, LLC · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −4 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −3 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −2 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −1 | K070882 | Stryker Peek Twinloop Tac | Stryker Endoscopy | 2007 | — |
| 0 (this device) | K120509 | Stryker All Suture Anchors | Stryker | 2012 | — |
| +1 | K133671 | Iconix All Suture Anchors | Stryker Corp. | 2014 | — |
| +2 | K151201 | Stryker ICONIX with Needles | Stryker | 2015 | — |
| +3 | K173074 | ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor | Stryker | 2018 | — |
| +4 | K231078 | All-Suture Anchor | Riverpoint Medical, LLC | 2023 | — |
| +3 | K231278 | Knotless Suture Anchor | Riverpoint Medical, LLC | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070882 | Stryker Peek Twinloop TacSummary page 1…Phone: (303) 336-7285; Fax (303) 370-5775 Email: kellyikucharczyk~stryker.com Legally Marketed Devices to Which K070882 - Stryker PEEK TwinLoop Tac Substantial Equivalence Is Claimed: K] 10145 - Biomet JuggerKnot Date Prepared:… | 2007 |
| Kept off the family tree | K101045 | Biomet JuggerKnot Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (27)
See all 272 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 16 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K133671 (Stryker Corp., 2014) has gone furthest, with 25 descendants of its own.
- 2 other devices also cite its predicate K070882.
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. 2012, 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?
Elbow: Biceps Tendon re-attachment, ulnar or radial collateral ligament reconstruction Shoulder: Rotator Cuff repair, Bankart repair, SLAP lesion repair, Biceps tendonesis, Acromio-clavicular separation repair, Deltoid Repair, Capsular shift or capsulolabral repair Hand/Wrist: Scaphulolunate ligament reconstruction, carnal ligament reconstruction, repair/recohistruction of collateral ligaments, repair. of Flexor and Extensor Tendons at the PIP, DIP and…
Read the full statement (118 words)
Elbow: Biceps Tendon re-attachment, ulnar or radial collateral ligament reconstruction
Shoulder: Rotator Cuff repair, Bankart repair, SLAP lesion repair, Biceps tendonesis, Acromio-clavicular separation repair, Deltoid Repair, Capsular shift or capsulolabral repair
Hand/Wrist: Scaphulolunate ligament reconstruction, carnal ligament reconstruction, repair/recohistruction 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 repai r, Patellar tendon repair, Posterior oblique ligament repair, iliotibial band tendonesis
Hip2 : Capsular repair, acetabular labral repair
The Stryker All Suture Anchors are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120509 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120509: Stryker All Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120509
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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