Medical Device Manufacturer · US , Malwah , NJ

Stryker Orthopaedics

24 submissions · 24 cleared · Since 2004
24
Total
24
Cleared
0
Denied

Stryker Orthopaedics — FDA 510(k) Submissions

Stryker Orthopaedics has submitted 24 FDA 510(k) premarket notifications since 2004, of which 24 received clearance as substantially equivalent to a predicate device.

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

24 devices
1–24 of 24
Insignia Hip Stem
K211703 · MEH Prosthesis, Hip,... · Orthopedic
Aug 2021 74d
EXETER Centralizer, EXETER 2.5mm Plug
K191414 · JDI Prosthesis, Hip,... · Orthopedic
Aug 2019 92d
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
K173499 · JDG Prosthesis, Hip, Femoral... · Orthopedic
Mar 2018 126d
Triathlon Total Knee System
K173849 · MBH Prosthesis, Knee,... · Orthopedic
Feb 2018 45d
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
K172326 · JWH Prosthesis, Knee,... · Orthopedic
Oct 2017 90d
Stryker Orthopaedics Hip Systems Labeling Update
K153345 · LPH Prosthesis, Hip,... · Orthopedic
May 2016 188d
Restoration Anatomic Shell
K151264 · LPH Prosthesis, Hip,... · Orthopedic
Aug 2015 89d
Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach
K143085 · LPH Prosthesis, Hip,... · Orthopedic
Feb 2015 105d
Triathlon Tritanium Cone Augments
K143393 · MBH Prosthesis, Knee,... · Orthopedic
Jan 2015 48d
Restoration Anatomic Shell
K142462 · LPH Prosthesis, Hip,... · Orthopedic
Nov 2014 73d
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
K141056 · MBH Prosthesis, Knee,... · Orthopedic
Aug 2014 103d
TRIATHLON TRITANIUM METAL-BACKED PATELLA
K132624 · MBH Prosthesis, Knee,... · Orthopedic
Nov 2013 96d
TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE
K072575 · MBH Prosthesis, Knee,... · Orthopedic
Jan 2008 116d
DALL-MILES SYSTEM
K070170 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2007 43d
PCA ALUMINA FEMORAL HEADS
K063816 · LZO Prosthesis, Hip,... · Orthopedic
Feb 2007 42d
MODIFICATION TO HIPSTAR FEMORAL STEM
K063822 · LPH Prosthesis, Hip,... · Orthopedic
Jan 2007 30d
SIMPLEX P BONE CEMENT
K062553 · LOD Bone Cement · Orthopedic
Jan 2007 131d
HIPSTAR FEMORAL STEM
K051223 · LZO Prosthesis, Hip,... · Orthopedic
May 2006 363d
TRIATHLON TOTAL KNEE SYSTEM
K053514 · JWH Prosthesis, Knee,... · Orthopedic
Jan 2006 41d
SHORT CITATION FEMORAL STEM
K053528 · MEH Prosthesis, Hip,... · Orthopedic
Jan 2006 25d
ACCOLADE RPS HIP STEM
K052542 · LZO Prosthesis, Hip,... · Orthopedic
Sep 2005 12d
ACCOLADE HFX FEMORAL STEM
K051741 · LZO Prosthesis, Hip,... · Orthopedic
Sep 2005 90d
SOLAR 2 ANATOMIC SHOULDER
K040432 · HSD Prosthesis, Shoulder,... · Orthopedic
Jan 2005 323d
TRIDENT T ACETABULAR SHELLS
K040412 · LPH Prosthesis, Hip,... · Orthopedic
May 2004 97d
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