510(k) Report

510(k) · Cleared

Cleared

Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink SP (TM) Knotless Anchor with Inserter, 4.5

K112876510(k) TraditionalCleared Dec 15, 201176-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cayenne Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Dec 15, 2011 as substantially equivalent to K093897 (Smith & Nephew Inc., Endoscopy Div., 2010) and 1 other predicate after a 76-day review. Its family tree reaches back 4 generations to 1997. 7 later devices descend from it.

Decided
Dec 15, 2011
Review
76 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K971723 (1997). 7 ancestors in all, the oldest K915889 (1992). 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1992: 1 other ancestor2000: 1 other ancestor2012: 1 descendant cleared2019: 2 descendants cleared2015: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK971723 · Fastak Suture Anchor (11.7MM)/(7.5MM) · Arthrex, Inc. · 1997K051219 · Pushlock · Arthrex, Inc. · 2005K073509 · Twinfix PK FP Suture Anchor · Smith & Nephew, Inc. · 2008K093897 · Smith & Nephew Footprint Ultra PK Suture Anchor · Smith & Nephew Inc., Endoscopy Div. · 2010 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 2 descendants K093897 · Smith & Nephew Footprint Ultra PK Suture Anchor · Smith & Nephew Inc., Endoscopy Div. · 2010 · recalledK073509 · Twinfix PK FP Suture Anchor · Smith & Nephew, Inc. · 2008K051219 · Pushlock · Arthrex, Inc. · 2005K971723 · Fastak Suture Anchor (11.7MM)/(7.5MM) · Arthrex, Inc. · 19970
  1. Root · 4 generations backK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
  2. 3 generations backK051219 PushlockArthrex, Inc. · 2005
  3. 2 generations backK073509 Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008
  4. 1 generation backK093897 Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
  5. This deviceK112876 Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek…Cayenne Medical, Inc. · 2011
  6. Descendant · cites it directly · 6 of its ownK122314 Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc. · 2012
  7. Descendant · 2 generations on · 2 of its ownK182507 Tigon Medical Tissue AnchorsTigon Medical · 2019
  8. Descendant · 3 generations on · 1 of its ownK220464 Tigon Medical Gryphon Anchor LineTigon Medical · 2023
  9. Descendant · 3 generations on · 0 of its ownK260921 Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture…Tigon Medical · 2026
  10. Descendant · 2 generations on · 0 of its ownK210498 Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd. · 2021 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012: 12015: 12019: 22021: 12023: 12026: 1
2012high 2 (2019) · low 0 (2013)2026

Most influential descendants

Showing 5 of 7 · See all
  • K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc. · 2012 · cites it directly6descendants
  • K182507Tigon Medical Tissue AnchorsTigon Medical · 2019 · 2 generations on2descendants
  • K220464Tigon Medical Gryphon Anchor LineTigon Medical · 2023 · 3 generations on1descendant
  • K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical · 2026 · 3 generations on0descendants
  • K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K971723Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc.1997—
−3K051219PushlockArthrex, Inc.2005—
−2K073509Twinfix PK FP Suture AnchorSmith & Nephew, Inc.2008—
−1K093897Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div.20102
0 (this device)K112876Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink…Cayenne Medical, Inc.2011—
+1K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc.2012—
+2K182507Tigon Medical Tissue AnchorsTigon Medical2019—
+3K220464Tigon Medical Gryphon Anchor LineTigon Medical2023—
+3K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical2026—
+2K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.20211

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
200010
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201510
201920
202110
202310
202610
FIG. 1 — Lineage of K112876, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K093897Smith & Nephew Footprint Ultra PK Suture Anchor
Summary page 2
…s to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897) and DePuy Mitek Gil Anchors (K041 115). Revised P…
Smith & Nephew Inc., Endoscopy Div.20102
*K041115Gii Quickanchor Plus
Summary page 2
…has been determined by FDA to be substantially equivalent to preamendment devices: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897) and DePuy Mitek Gil Anchors (K041 115). Revised Page 18 of 142…
Depuy Mitek, A Johnson & Johnson Company20041

Also cleared against K093897: 9 other devices →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc.20126

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 14 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K122314 (Cayenne Medical, Inc., 2012) has gone furthest, with 6 descendants of its own.
  • 9 other devices also cite its predicate K093897.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

The Cayenne Medical, Inc. CuffLink Knotless Anchors are intended for use for the reattachment of soft tissue to bone for shoulder procedures such as Rotator Cuff Repairs.

Indications for use as stated in the FDA summary.

Also cleared against K093897

9 other devices cite the same predicate.

  • K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P…Suzhou Endophix Co., Ltd. · 2023
  • K182264ICONN Revolution Knotless Suture AnchorIconn Orthopedics, LLC · 2018
  • K173269KATOR Suture AnchorKator, LLC · 2018
  • K180274Ventix Link Knotless Anchor with InserterCayenne Medical, Inc. · 2018
  • K171964LigaMetrics Suture AnchorsMortise Medical, LLC · 2017
  • K123579Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc. · 2013

More from Cayenne Medical, Inc.

22 FDA decisions under this applicant name. See the company

  • K180274Ventix Link Knotless Anchor with InserterCayenne Medical, Inc. · 2018
  • K172186BioWick X Implant with DriverCayenne Medical, Inc. · 2017
  • K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. · 2016
  • K151068SureLock W Suture AnchorCayenne Medical, Inc. · 2015
  • K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock…Cayenne Medical, Inc. · 2015

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K112876 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112876: Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink SP (TM) Knotless Anchor with Inserter, 4.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112876

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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