Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates

FDA 510(k)

FDA Class 2 ·Orthopedic

MOUNTAINEER OCT SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TORNIER INSITE FT SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75

FDA 510(k)

FDA Class 2 ·Orthopedic

PALAMED BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

FDA 510(k)

FDA Class 2 ·Orthopedic

Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO EBI SPINELINK SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TITANIUM ALLOY BONE SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

AMSET LOCKING PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

IST PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)

FDA 510(k)

FDA Class 2 ·Orthopedic

FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES

FDA 510(k)

FDA Class 2 ·Orthopedic

MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

PERLA® TL Posterior Osteosynthesis System

FDA 510(k)

FDA Class 2 ·Orthopedic

ACUFEX TAG ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER

FDA 510(k)

FDA Class 2 ·Orthopedic

NUVASIVE SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310

FDA 510(k)

FDA Class 2 ·Orthopedic