TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO— 510(k) K130033

Name: FDA 510(k) clearance K130033
Creator: U.S. Food and Drug Administration
Published: 2013-08-01

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K130033 for TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO, Substantially Equivalent on 2013-08-01. Applicant: Biomet Manufacturing Corp. Device class: 2.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2013-01-04
Decision date: 2013-08-01
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 K130033

K-number listed on FDA's recall record

Z-0212-2026 — BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint RepairClass II·Ongoing·Biomet, Inc.·20250923
Z-0818-2018 — Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.Class II·Terminated·Zimmer Biomet, Inc.·20170822
Z-1363-2015 — ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease.Class II·Terminated·Biomet, Inc.·20150226

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130033.

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