JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF— 510(k) K123485

Clearance details

Applicant

Biomet Sports Medicine

Product code

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2012-11-13

Decision date

2013-03-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• K262809 — ArthroTAK Tendon Anchor Kit2026-09-02
• K262677 — Iconix Knotless T2026-08-27
• K262047 — Grappler Suture Anchor System2026-08-03
• K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down2026-07-30

• K140908 — JUGGERKNOT MINI SOFT ANCHOR2014-10-02
• K122437 — NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS2013-10-18
• K110879 — BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR2011-08-19
• K111564 — MAXFIRE MARXMEN MENISCAL REPAIR DEVICE2011-06-16
• K110039 — BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM2011-05-03

Injury

3,163

Malfunction

13,006

Other

2

Total

16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1828-2016 — Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.Class II·Terminated·Biomet, Inc.·20160401
• Z-0364-2014 — Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.Class II·Terminated·Biomet, Inc.·20131010

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123485.