BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR— 510(k) K110879
Substantially EquivalentBiomet Sports Medicine
FDA 510(k) clearance K110879 for BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR, Substantially Equivalent on 2011-08-19. Applicant: Biomet Sports Medicine. Device class: 2.
Clearance details
- Applicant
- Biomet Sports Medicine
- Product code
- Code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code MBI
view allMore clearances from Biomet Sports Medicine
view all- K140908 — JUGGERKNOT MINI SOFT ANCHOR
- K122437 — NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
- K123485 — JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
- K111564 — MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
- K110039 — BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
Adverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K110879
K-number listed on FDA's recall record- Z-2619-2025 — Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
- Z-1828-2016 — Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110879.
Data sourced from openFDA. This site is unofficial and independent of the FDA.