Medical Device Manufacturer · US , Allendale , NJ

Howmedica Osteonics Corp.

288 submissions · 288 cleared · Since 1999
288
Total
288
Cleared
0
Denied

Howmedica Osteonics Corp. — FDA 510(k) Submissions

Howmedica Osteonics Corp. has submitted 288 FDA 510(k) premarket notifications since 1999, of which 288 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Rod, Fixation, Intramedullary And Accessories, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented, Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate . Use the specialty filter in the sidebar to narrow results.

288 devices
1–25 of 288
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
K193429 · JDI Prosthesis, Hip,... · Orthopedic
Aug 2020 247d
Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
K200782 · MBH Prosthesis, Knee,... · Orthopedic
May 2020 48d
REUNION RSA SHOULDER SYSTEM
K130895 · PHX Shoulder Prosthesis,... · Orthopedic
Dec 2013 270d
ABG III MONOLITHIC HIP STEM
K123604 · MAY Prosthesis, Hip,... · Orthopedic
Aug 2013 268d
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
K122015 · KRO Prosthesis, Knee,... · Orthopedic
Feb 2013 227d
TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P
K123166 · JWH Prosthesis, Knee,... · Orthopedic
Feb 2013 128d
NOVEL FIT AND FILL STEM
K122853 · MEH Prosthesis, Hip,... · Orthopedic
Feb 2013 136d
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
K121315 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
Nov 2012 183d
HIP SYSTEMS
K121308 · LPH Prosthesis, Hip,... · Orthopedic
Jul 2012 90d
S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL
K113409 · HSB Rod, Fixation,... · Orthopedic
Feb 2012 89d
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
K112556 · MEH Prosthesis, Hip,... · Orthopedic
Sep 2011 26d
EXETER HIP STEM
K110290 · JDI Prosthesis, Hip,... · Orthopedic
Sep 2011 238d
REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N
K103835 · KWS Prosthesis, Shoulder,... · Orthopedic
May 2011 126d
TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
K101072 · LPH Prosthesis, Hip,... · Orthopedic
Apr 2011 357d
MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
K103233 · LZO Prosthesis, Hip,... · Orthopedic
Feb 2011 93d
T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES
K102992 · HSB Rod, Fixation,... · Orthopedic
Dec 2010 75d
SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
K103104 · KWS Prosthesis, Shoulder,... · Orthopedic
Nov 2010 33d
STRYKER KNIFELIGHT
K100884 · FTD Lamp, Surgical · General & Plastic Surgery
Jun 2010 87d
T2 GREATER TROCHANTER NAIL
K101438 · HSB Rod, Fixation,... · Orthopedic
Jun 2010 24d
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
K100271 · HRS Plate, Fixation, Bone · Orthopedic
May 2010 105d
VARIAX ELBOW SYSTEM
K101056 · HRS Plate, Fixation, Bone · Orthopedic
May 2010 28d
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS
K100475 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2010 71d
STRYKER SONICPIN SYSTEM
K091955 · HTY Pin, Fixation, Smooth · Orthopedic
Apr 2010 275d
VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
K093433 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2010 85d
RESTORATION ADM SYSTEM X3 ACETABULAR
K093644 · MEH Prosthesis, Hip,... · Orthopedic
Dec 2009 23d

Looking for a specific device from Howmedica Osteonics Corp.? Search by device name or K-number.

Search all Howmedica Osteonics Corp. devices
Filters