Medical Device Manufacturer · US , Mchenry , IL

Biomet, Inc.

440 submissions · 418 cleared · Since 1978
440
Total
418
Cleared
0
Denied

Biomet, Inc. — FDA 510(k) Submissions

Biomet, Inc. has submitted 440 FDA 510(k) premarket notifications since 1978, of which 418 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Screw, Fixation, Bone, Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented . Use the specialty filter in the sidebar to narrow results.

440 devices
1–25 of 440
Biomet Kirschner Wires (K-Wires)
K241014 · HTY Pin, Fixation, Smooth · Orthopedic
May 2024 40d
StageOne? Select Hip Cement Spacer Molds
K222760 · MBB Bone Cement, Antibiotic · Orthopedic
Dec 2022 106d
StageOne? Shoulder Cement Spacer Molds
K221968 · MBB Bone Cement, Antibiotic · Orthopedic
Sep 2022 72d
StageOne Knee Cement Spacer Molds
K213287 · MBB Bone Cement, Antibiotic · Orthopedic
Sep 2022 336d
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
K212431 · JDG Prosthesis, Hip, Femoral... · Orthopedic
Feb 2022 187d
Comprehensive Humeral Fracture Positioning Sleeves
K212435 · KWS Prosthesis, Shoulder,... · Orthopedic
Dec 2021 128d
A.L.P.S. Clavicle Plating System
K210192 · HRS Plate, Fixation, Bone · Orthopedic
Feb 2021 25d
WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws
K193214 · MBI Fastener, Fixation,... · Orthopedic
Nov 2020 355d
Distal Centralizers
K193546 · JDG Prosthesis, Hip, Femoral... · Orthopedic
Sep 2020 280d
Comprehensive? Reverse Shoulder
K193373 · PHX Shoulder Prosthesis,... · Orthopedic
Apr 2020 132d
ALLthread PEEK Suture Anchor
K193402 · MBI Fastener, Fixation,... · Orthopedic
Mar 2020 90d
Titanium Interference Screws
K193451 · HWC Screw, Fixation, Bone · Orthopedic
Feb 2020 73d
WIN Flexible Nail System
K193533 · JDS Nail, Fixation, Bone · Orthopedic
Feb 2020 62d
ALLthread Titanium Suture Anchor
K192942 · MBI Fastener, Fixation,... · Orthopedic
Jan 2020 90d
TunneLoc Tibial Fixation Device
K193092 · MBI Fastener, Fixation,... · Orthopedic
Jan 2020 57d
JuggerStitch Meniscal Repair Device
K191459 · MBI Fastener, Fixation,... · Orthopedic
Sep 2019 102d
Biomet Headless Compression and Twist-Off Screws
K190035 · HWC Screw, Fixation, Bone · Orthopedic
Feb 2019 30d
Compress and Mini Compress Anti-Rotation Spindles
K183553 · MBF Prosthesis, Shoulder,... · Orthopedic
Jan 2019 33d
Affixus Hip Fracture Nail
K183162 · HSB Rod, Fixation,... · Orthopedic
Dec 2018 29d
A. L. P. S. Clavicle Plating System
K173767 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2018 116d
THP Hip Fracture Plating System
K173826 · JDO Device, Fixation,... · Orthopedic
Feb 2018 51d
ToggleLoc System
K173278 · MBI Fastener, Fixation,... · Orthopedic
Jan 2018 84d
Biomet Bone Cement R
K172408 · LOD Bone Cement · Orthopedic
Oct 2017 57d
Refobacin Bone Cement R
K171540 · LOD Bone Cement · Orthopedic
Aug 2017 96d
Biomet Knee Joint Replacement Prostheses
K171054 · JWH Prosthesis, Knee,... · Orthopedic
Jul 2017 109d

Looking for a specific device from Biomet, Inc.? Search by device name or K-number.

Search all Biomet, Inc. devices
Filters