510(k) · Cleared
ClearedKATOR Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kator, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on May 30, 2018 as substantially equivalent to K101823 (Arthrex, Inc., 2011) and 4 other predicates after a 230-day review. Its family tree reaches back 7 generations to 1996. 2 later devices descend from it.
- Decided
- May 30, 2018
- Review
- 230 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K961555 (1996). 22 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- 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 backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 3 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 2 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- 1 generation backK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- This deviceK173269 KATOR Suture AnchorKator, LLC · 2018
- Descendant · cites it directly · 0 of its ownK242477 Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK182736 OIC Suture Anchor SystemThe Orthopaedic Implant Company · 2018
Most influential descendants
Showing 2 of 2 · See allView 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 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −3 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −2 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| −1 | K101823 | Arthrex Swivelock Anchors | Arthrex, Inc. | 2011 | 6 |
| 0 (this device) | K173269 | KATOR Suture Anchor | Kator, LLC | 2018 | — |
| +1 | K242477 | Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty, Ltd. | 2025 | — |
| +1 | K182736 | OIC Suture Anchor System | The Orthopaedic Implant Company | 2018 | — |
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 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K101823 | Arthrex Swivelock AnchorsSummary page 5…a bone tunnel and a suture locking pin that secures soft tissue repair suture tape within the implant. Predicate Devices: The Arthrex, Inc., Arthrex SwiveLock Anchors (K101823), Smith & Nephew, Inc., Footprint PK Suture Anchor (K093897, K113274, K123579) and the KATOR LLC, KATOR Suture Anchor (K162386) s… | 2011 |
| * | K093897 | Smith & Nephew Footprint Ultra PK Suture AnchorSummary page 5…ssue repair suture tape within the implant. Predicate Devices: The Arthrex, Inc., Arthrex SwiveLock Anchors (K101823), Smith & Nephew, Inc., Footprint PK Suture Anchor (K093897, K113274, K123579) and the KATOR LLC, KATOR Suture Anchor (K162386) serve as predicate devices. Technological Characteristics Co… | 2010 |
| * | K113274 | Footprint Ultra PK Suture AnchorSummary page 5…ir suture tape within the implant. Predicate Devices: The Arthrex, Inc., Arthrex SwiveLock Anchors (K101823), Smith & Nephew, Inc., Footprint PK Suture Anchor (K093897, K113274, K123579) and the KATOR LLC, KATOR Suture Anchor (K162386) serve as predicate devices. Technological Characteristics Comparison:… | 2012 |
| * | K123579 | Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSummary page 5…tape within the implant. Predicate Devices: The Arthrex, Inc., Arthrex SwiveLock Anchors (K101823), Smith & Nephew, Inc., Footprint PK Suture Anchor (K093897, K113274, K123579) and the KATOR LLC, KATOR Suture Anchor (K162386) serve as predicate devices. Technological Characteristics Comparison: The KATO… | 2013 |
| * | K162386 | KATOR Suture AnchorSummary page 5…Arthrex, Inc., Arthrex SwiveLock Anchors (K101823), Smith & Nephew, Inc., Footprint PK Suture Anchor (K093897, K113274, K123579) and the KATOR LLC, KATOR Suture Anchor (K162386) serve as predicate devices. Technological Characteristics Comparison: The KATOR Suture Anchor subject device and the predicates… | 2016 |
What descends from it? (2)
2 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 22 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K242477 (Signature Orthopaedics Pty, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K101823.
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 KATOR Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, 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…
Read the full statement (121 words)
The KATOR Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, 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.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173269: KATOR 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/K173269
Report an extraction error
Are you the manufacturer?
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