510(k) Report

510(k) · Cleared

Cleared

Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe Suture

K112960510(k) TraditionalCleared Jan 9, 201296-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 9, 2012 as substantially equivalent to K071586 (Smith & Nephew Inc., Endoscopy Division, 2007) and 4 other predicates after a 96-day review. Its family tree reaches back 5 generations to 1999. 1 later device descends from it.

Decided
Jan 9, 2012
Review
96 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K990088 (1999). 25 ancestors in all, the oldest K930738 (1994). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 1 other ancestor2007: 2 other ancestors2004: 2 other ancestors2006: 2 other ancestors1994: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor2001: 3 other ancestors2000: 3 other ancestors1998: 1 other ancestor1996: 2 other ancestors2013: 1 descendant clearedK990088 · 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) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors4 generations back: 8 other ancestors5 generations back: 2 other ancestors 1 generation forward: 1 descendant 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 deviceK112960 Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1)…Cayenne Medical, Inc. · 2012
  7. Descendant · cites it directly · 0 of its ownK131325 Quattro GL Suture AnchorCayenne Medical, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K131325Quattro GL Suture AnchorCayenne Medical, Inc. · 2013 · cites it directly0descendants
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)K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2)…Cayenne Medical, Inc.2012—
+1K131325Quattro GL Suture AnchorCayenne Medical, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199620
199810
200030
200130
200310
200420
200510
200620
200720
200910
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K112960, 1999–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K071586Bioraptor 2.3 PK Suture Anchor
Summary page 2
…les to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor (K07 1586), Force Fiber Blue Co-Braid Polyethylene non-absorbable surgical suture (K040472), Force Fiber Black Co-Braid Polyethylene non-ab…
Smith & Nephew Inc., Endoscopy Division20071
*K040472Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture
Summary page 2
…ally equivalent to preamendment devices: Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor (K07 1586), 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
…chor (K07 1586), 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 (K 100506), 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 (K 100506), 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 (K 100506), and Force Fiber Blue Polyethylene non-absorbable surgical suture (K092533). Revised Page 18 of 159 K1 12960- LabraLink Sut…
Beere Precision Medical Instruments, Kmedic, Telef2009—

Also cleared against K071586: 22 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K131325Quattro GL Suture AnchorCayenne Medical, Inc.20130

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.
  • 9 of the 25 ancestors have a recall of any class.
  • Of its descendants, K131325 (Cayenne Medical, Inc., 2013) has gone furthest, with 0 descendants of its own.
  • 22 other devices also cite its predicate K071586.

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. LabraLinkTm Suture Anchor is intended for the reattachment of soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair.

Indications for use as stated in the FDA summary.

Also cleared against K071586

22 other devices cite the same predicate.

  • K233730Footprint Mini PK, 3.5mm Suture AnchorSmith & Nephew · 2024
  • K231376Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)Smith & Nephew, Inc. · 2023
  • K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc. · 2018
  • K153395OS2-C Compression StapleIn2bones Sas · 2016
  • K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG…Smith & Nephew, Inc. · 201540 recalls
  • K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 20142 recalls

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/K112960 · printed Nov 3, 2026

Cite this page

510(k) Report. “K112960: Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112960

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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