Brainlab Knee 3.0 System

Singapore - English - HSA (Health Sciences Authority)

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Available from:
BRAINLAB LIMITED (SINGAPORE BRANCH)
Class:
Class B medical device
Manufactured by:
Brainlab AG
Therapeutic area:
Orthopaedics
Therapeutic indications:
Knee 3.0 is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient’s bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, x-ray, MR-based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Knee 3.0. Example orthopedic surgical procedures include but are not limited to: • Total Knee Replacement • Ligament Balancing • Range of Motion Analysis
Product summary:
Device System Info:[Device with measuring function], [System or Procedure Pack], System with instruments and accessories; Models: 4 IN 1 CUTTING BLOCK TEMPLATE SMITH & NEPHEW GENESIS II - 41838, 4 IN 1 CUTTING BLOCK TEMPLATE DEPUY PFC - 41867, 4 IN 1 CUTTING BLOCK TEMPLATE SMITH & NEPHEW JOURNEY - 41871, REFERENCE ARRAY T-GEOMETRY X-PRESS - 52410, REFERENCE ARRAY Y-GEOMETRY X-PRESS - 52411, BONE FIXATOR 2-PIN X-PRESS - 52420, BONE FIXATOR 1-PIN X-PRESS SIZE-S - 52421, BONE FIXATOR 1-PIN X-PRESS SIZE-M - 52422, BONE FIXATOR 1-PIN X-PRESS SIZE-L - 52423, 1-PIN WRENCH X-PRESS / SPINE CLAMPS - 52424, 2-PIN DRILL TEMPLATE X-PRESS - 52425, CAS CUTTING BLOCK KIT BASIC UNIVERSAL - 52427, POINTER ANGLED FOR HIP/KNEE - 53101, KNEE PLANE TOOL KIT - 53200, KNEE PLANE TOOL - TRACKING ARRAY - 53201, KNEE PLANE TOOL - CUTTING BLOCK ADAPTER - 53202, E PLANE TOOL - BONE VERIFICATION PLATE - 53203, ADJUSTABLE CUTTING BLOCK - ADJUSTMENT UNIT - 53210, ADJUSTABLE CUTTING BLOCK - REFERENCE ARRAY Y-GEOMETRY - 53211, ADJUSTABLE CUTTING BLOCK - FEMORAL ALIGNEMENT GUIDE - 53212, ADJUSTABLE CUTTING BLOCK - FEMORAL BASE PLATE - 53213, FEMORAL BASE PLATE SMALL - 53219, ADJUSTABLE CUTTING BLOCK - CUTTING SLOT FEMUR 1.19MM - 53220, ADJUSTABLE CUTTING BLOCK - CUTTING SLOT FEMUR 1.27MM - 53221, JUSTABLE CUTTING BLOCK - CUTTING SLOT FEMUR 1.37MM - 53222, PINDRIVER ADAPTER FOR AO COUPLING - 54932, FEMORAL AND TIBIAL CUTTING BLOCK ADAPTER UNIVERSAL - 41866-77, DISP CLIP-ON REMOTE CONTROL - 53153, PATIENT BROWSER AND CONTENT MANAGER - 25100, DISPOSABLE STERILE TOUCHPENS - 54270, STERILIZATION TRAY KNEE REPLACEMENT - 52302, ADJUSTABLE CUTTING BLOCK - STERILIZATION TRAY - 52314, KICK NAVIGATION STATION - 18070, KICK MONITOR CART - 18071, KICK CAMERA CART - 18072, KICK NAVIGATION STATION (WITH REFURBISHED CAMERA - 18078, DISPOSABLE STERILE MONITOR DRAPES FOR KICK (40 PCS) - 18071-50, CURVE SINGLE DISPLAY NAVIGATION STATION - 19905, MONITOR CART - CURVE SINGLE DISPLAY - 19905-01, CAMERA CART - CURVE SINGLE DISPLAY - 19905-02, CAMERA CART-CURVE SINGLDISPLAY SPAREPART - 19905-03, MONITOR CART-CURVE SINGLE DISP SPAREPART - 19905-04, CURVE DUAL DISPLAY NAVIGATION STATION - 19900, MONITOR CART - CURVE DUAL DISPLAY - 19900-01, CAMERA CART - CURVE DUAL DISPLAY - 19900-02, CAMERA CART - CURVE DUAL DISPLAY SPAREPART - 19900-03, MONITOR CART - CURVE DUAL DISPLAY SPAREPART - 19900-04, Pointer Knee Straight (bundle with gauge) - 53109, Bone Fixator "2-Pin", X-Press Flip-Flop - 52429, ClearLens Knee Plane Tool – Interface - 53238, ClearLens Pointer Handle – Knee - 53237, ClearLens Pointer Gauge – Knee - 53237-10, ClearLens Bone Fixator 2-Pin – Left - 53239, ClearLens Bone Fixator 2-Pin – Right - 53240, ClearLens Tracking Array Set For Knee - 53236, ClearLens Tracking Array Set For Knee (16 pcs) - 53245, KICK 2 NAVIGATION STATION DPS - 18180, KICK 2 NAVIGATION STATION - 18170, KICK 2 CAMERA CART - 18178, KICK 2 MONITOR CART - 18171, Sterilization Tray for Knee3 ClearLens - 52318, Knee Plane Tool – Bone Verification Plate - Small - 53204, Navigation Software Knee3 - 04056481138806, Plane Tool Bone Verification Plate Partial - 53205
Authorization number:
DE0017521
Authorization date:
2015-10-01

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