SLEEVE WITH ZIPLOOP FIXATION DEVICES— 510(k) K101063

Name: FDA 510(k) clearance K101063
Creator: U.S. Food and Drug Administration
Published: 2010-06-23

Substantially Equivalent

Biomet Sports Medicine

FDA 510(k) clearance K101063 for SLEEVE WITH ZIPLOOP FIXATION DEVICES, Substantially Equivalent on 2010-06-23. 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: 2010-04-16
Decision date: 2010-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MBI

product code MBI

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 →

Recalls naming K101063

K-number listed on FDA's recall record

Z-1364-2015 — Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative diseaseClass II·Terminated·Biomet, Inc.·20150226

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101063.

Data sourced from openFDA. This site is unofficial and independent of the FDA.