510(k) · Cleared
Recalled · Class II · 2023Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pivot Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 7, 2013 as substantially equivalent to K071586 (Smith & Nephew Inc., Endoscopy Division, 2007) after a 112-day review. Its family tree reaches back 5 generations to 1996. 12 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 7, 2013
- Review
- 112 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K961555 (1996). 7 ancestors in all. 12 later devices descend from it, 3 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 backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 1 generation backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- This deviceK131769 Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MMPivot Medical, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK173074 ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker · 2018
- Descendant · cites it directly · 4 of its ownK180361 MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK231078 All-Suture AnchorRiverpoint Medical, LLC · 2023
- Descendant · 2 generations on · 3 of its ownK181746 MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK251809 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker · 2018 · cites it directly5descendants
- K180361MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc. · 2018 · cites it directly4descendants
- K231078All-Suture AnchorRiverpoint Medical, LLC · 2023 · 2 generations on3descendants
- K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc. · 2018 · 2 generations on3descendants
- K251809Arthrex FiberTak Suture AnchorArthrex, Inc. · 2025 · 3 generations on1descendant
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 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −1 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| 0 (this device) | K131769 | Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MM | Pivot Medical, Inc. | 2013 | — |
| +1 | K173074 | ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor | Stryker | 2018 | — |
| +1 | K180361 | MICRORAPTOR REGENESORB Suture Anchor | Smith and Nephew, Inc. | 2018 | — |
| +2 | K231078 | All-Suture Anchor | Riverpoint Medical, LLC | 2023 | — |
| +2 | K181746 | MICRORAPTOR Knotless Suture Anchor | Smith and Nephew, Inc. | 2018 | — |
| +3 | K251809 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K071586 | Bioraptor 2.3 PK Suture AnchorSummary page 1…r threaded metallic bone fixation fastener Regulation number: 21 CFR 888.3040 Product Code: MBI Predicate Devices Smith and Nephew BioRaptor 2.3PK Suture Anchor - K071586 Device Description The Pivot Suture Anchors which are part of this expanded indications submission are as follows: Pivot CinchLoc… | 2007 |
What descends from it? (12)
See all 123 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2023 | Class II | Z-2645-2023 | Unknown/Undetermined by firm | Expired Product distributed |
| Apr 12, 2016 | Class II | Z-1634-2016 | Device Design | Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking upon deployment of the anchor. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K173074 (Stryker, 2018) has gone furthest, with 5 descendants of its own.
- 22 other devices also cite its predicate K071586.
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. 2013, 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 NanoTack Suture Anchor, previously cleared under 510(k) K110473 and K130351, is intended for fixation of soft tissue to bone In the hip, shoulder, foot/ankle, hand/wrist. elbow, and knee, in the following procedures: Hip capsule repair Acetabular labrum reattachment Shoulder Capsular stabilization - Bankart repair -Anterior shoulder instability -SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromilavicular separation repairs…
Read the full statement (264 words)
The NanoTack Suture Anchor, previously cleared under 510(k) K110473 and K130351, is intended for fixation of soft tissue to bone In the hip, shoulder, foot/ankle, hand/wrist. elbow, and knee, in the following procedures:
Hip capsule repair
Acetabular labrum reattachment
Shoulder
Capsular stabilization
- Bankart repair
-Anterior shoulder instability
-SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
Acromilavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodes
Foot and Ankle
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy
Elbow, Wrist, and Hand
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair
Knee
Extra-capsular repairs
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
Patellar realignment and tendon repairs
- Vastus medialis obliquous advancement
Iliotibial band tenodesis
The CinchLock Knotless Anchor, previously cleared under 510(k) K123651, is intended for fixation of soft tissue to bone In the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee, in the following procedures:
Hip capsule repair
Acetabular labrum reattachment
Shoulder
Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
Acromilavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis
Foot and Ankle
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy
Elbow, Wrist, and Hand
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair
Knee
Extra-capsular repairs
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
Patellar realignment and tendon repairs
- Vastus medialis obliquous advancement
Iliotibial band tenodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131769: Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131769
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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