510(k) Report

510(k) · Cleared

Cleared

Cuffink

K112814510(k) TraditionalCleared Jan 17, 2012112-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 Jan 17, 2012 as substantially equivalent to K061863 (Arthrex, Inc., 2006) and 4 other predicates after a 112-day review. Its family tree reaches back 5 generations to 1999.

Decided
Jan 17, 2012
Review
112 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K990088 (1999). 23 ancestors in all, the oldest K930738 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2009: 1 other ancestor2006: 2 other ancestors2004: 2 other ancestors1994: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor1998: 1 other ancestor2001: 3 other ancestors2000: 3 other ancestors1996: 2 other ancestorsK990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 1999K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 2002×2: 2 generations cleared close together, K063778 (2007), K070673 (2007) 19901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors3 generations back: 4 other ancestors4 generations back: 7 other ancestors5 generations back: 1 other ancestor K070673 · Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture · Teleflexmedical, Inc. · 2007K063778 · Force Fiber Polyethylene Nonabsorbable Suture · Teleflex Medical · 2007 · recalledK021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 2002K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 1999−50
  1. Root · 5 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
  2. 4 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
  3. 3 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
  4. 2 generations backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
  5. 1 generation backK070673 Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007
  6. This deviceK112814 CuffinkCayenne Medical, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K990088Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc.1999—
−4K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc.2001—
−3K021434Arthrex Fiberwire in Usp SizesArthrex, Inc.2002—
−2K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical20071
−1K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc.2007—
0 (this device)K112814CuffinkCayenne Medical, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199620
199810
200030
200130
200310
200420
200510
200620
200910
201010
FIG. 1 — Lineage of K112814, 1999–2012Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family
Summary page 2
…ign principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Arthrex CorkscrewTM Suture Anchors (K061 863), Force Fiber Blue Co-Braid Polyethylene non-absorbable surgical suture (K040472), Force Fiber Black Co-Braid Polyethylene non-ab…
Arthrex, Inc.2006—
*K040472Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture
Summary page 2
…e substantially equivalent to preamendment devices: Arthrex CorkscrewTM Suture Anchors (K061 863), Force Fiber Blue Co-Braid Polyethylene non-absorbable surgical suture (K040472), Force Fiber Black Co-Braid Polyethylene non-absorbable surgical suture (K070673), Force Fiber Green Co-Braid Polyethylene non-a…
Teleflex Medical2004—
*K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture
Summary page 2
…hors (K061 863), Force Fiber Blue Co-Braid Polyethylene non-absorbable surgical suture (K040472), Force Fiber Black Co-Braid Polyethylene non-absorbable surgical suture (K070673), Force Fiber Green Co-Braid Polyethylene non-absorbable surgical suture (K100506), and Force Fiber Blue Polyethylene non- absorb…
Teleflexmedical, Inc.2007—
*K100506Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures…
Summary page 2
…ture (K040472), Force Fiber Black Co-Braid Polyethylene non-absorbable surgical suture (K070673), Force Fiber Green Co-Braid Polyethylene non-absorbable surgical suture (K100506), and Force Fiber Blue Polyethylene non- absorbable surgical suture (K092533).…
Teleflex Medical2010—
*K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures
Summary page 2
…al suture (K070673), Force Fiber Green Co-Braid Polyethylene non-absorbable surgical suture (K100506), and Force Fiber Blue Polyethylene non- absorbable surgical suture (K092533). Revised Page 18 of 156 DEPAR…
Beere Precision Medical Instruments, Kmedic, Telef2009—

Also cleared against K061863: 33 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 13 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
  • 8 of the 23 ancestors have a recall of any class.
  • 33 other devices also cite its predicate K061863.

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. 2012, 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. CuffLinkTM Suture Anchors are intended for use for the reattachment of soft tissue to bone for Rotator Cuff Repairs.

Indications for use as stated in the FDA summary.

Also cleared against K061863

33 other devices cite the same predicate.

  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K251145Arthrex PushLock Suture AnchorsArthrex, Inc. · 2025
  • K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P…Suzhou Endophix Co., Ltd. · 2023
  • K202444Knotless TensionTight Button Implant SystemArthrex, Inc. · 2020
  • K192949Flower Suture Anchor SetFlower Orthopedics Corporation · 2020
  • K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMedos International SARL · 2019

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/K112814 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112814: Cuffink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112814

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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