Cleared Traditional

BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS

K080088 · Biomet Manufacturing, Inc. · Orthopedic
Jun 2008
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K080088 is an FDA 510(k) clearance for the BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 11, 2008, 149 days after receiving the submission on January 14, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K080088 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2008
Decision Date June 11, 2008
Days to Decision 149 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

Similar Devices — HWC Screw, Fixation, Bone

All 1049
Treace Medical Concepts (TMC) Screw Fixation System
K260361 · Treace Medical Concepts, Inc. · Mar 2026
Tyber Medical Trauma Screw
K252901 · Tyber Medical, LLC · Dec 2025
Ultra? Compression Screw System
K251555 · Pace Surgical · Nov 2025
Eleganz IM Threaded Nail System (IM Threaded Nail System)
K252312 · Dev4 · Oct 2025
MetaFore Small Screw System
K250536 · Extremity Medical, LLC · Oct 2025
Cannulated Screw and Kirschner (K wire) System
K252758 · Orthonovis, Inc. · Oct 2025