BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR— 510(k) K110145

Clearance details

Applicant

Biomet, Inc.

Product code

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2011-01-18

Decision date

2011-03-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down2026-07-30

• K253434 — OSSTM Orthopedic Salvage System2026-07-01
• K251270 — Taperloc® Complete Hip Stem2026-05-19
• K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
• K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
• K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

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-3252-2018 — Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992Class II·Terminated·Zimmer Biomet, Inc.·20180803
• Z-1828-2016 — Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.Class II·Terminated·Biomet, Inc.·20160401

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110145.