Brainlab Hip

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

BRAINLAB LIMITED (SINGAPORE BRANCH)

Class:

Class B medical device

Manufactured by:

Brainlab AG

Therapeutic area:

Orthopaedics

Therapeutic indications:

The Brainlab hip system 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 either on a patient's preoperative image data being processed by Brainlab IGS platforms, or 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 considered to be safe and effective, 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, or MR-based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprosthesis to the preoperatively or intraoperatively planned position.

Product summary:

Device System Info:[Device with measuring function], Please refer to the User Guide for information regarding measuring function.; Models: Brainlab Hip - 27010-01, BrainLAB Curved Cup Impactor "Universal" Shaft - 52856, BL Impactor "Universal" Insert JMM AMS - 52855-01, BL Impactor "Univ" Insert JMM KMAX/QPOC - 52855-02, BL Impactor "Universal" Insert Depuy - 52855-03, INSERT FOR CUP IMPACTOR UNIVERSAL SMITH & NEPHEW - 52855-04, BL Impactor "Universal" Insert Zimmer - 52855-05, BL Impactor "Universal" Insert Biomet - 52855-07, BL Impactor "Universal" Insert Aesculap - 52855-08, BL Impactor "Universal" Insert Stryker - 52855-10, BL Impactor "Universal" Insert Corin - 52855-11, CUP REAMER STRAIGHT ADAPTER ZIMMER - 41879-02, Cup Reamer Adapter "BL" - 41879-04, CAS REAMER SET CURVED FOR AO - 41879-19, Clips Reamer ADP "Precimed EZ-Clean" - 41879-36, Clips Reamer ADP "Zimmer Full Hemisphr" - 41879-16, CUP REAMER STRAIGHT ADAPTER PRECIMED - 41879-03, Reamer Kit MPRO (Reamer Heads) - 41879-51, Drill Guide Handle - 41839, DRILL GUIDE KIT - BASIC - 41839-01, DRILL GUIDE KIT - CERVICAL - 41839-02, DRILL GUIDE KIT - MINIMAL INVASIVE - 41839-03, DRILL GUIDE KIT - ILIOSACRAL - 41839-04, DRILL GUIDE TUBE 3.0 X 150 MM - 41839-20, DRILL GUIDE TUBE 3.2 X 150 MM - 41839-30, DRILL BIT 3.2 MM AO SHANK - 41839-35, DRILL BIT - AO SHANK 3.2 MM DEPTH CONTROL - 41839-36, DRILL GUIDE TUBE 4.5 x 200 MM - 41839-40, DRILL GUIDE AO BONE DRILL 4.5 MM - 41839-45, DRILL GUIDE DEPTH CONTROL - 41839-50, DRILL GUIDE TUBE 2.6 x 150 MM - 41839-60, DRILL BIT - AO SHANK 2.6 MM DEPTH CONTROL - 41839-65, DRILL GUIDE AO BONE DRILL 2.6 MM - 41839-69, DRILL GUIDE TROCAR NEEDLE 1.8 MM - 41839-75, DRILL GUIDE TUBE 2.5 x 150 MM - 41839-80, Hip Caliper - 52876, Pinless Femur Reference Array Kit - 52400B, Pointer Square Angled for Hip - 53100, Pointer Angled for Hip/Knee - 53101, Pointer Ext. With Sharp Tip for H/T/S - 53103, Pointer Extended for Hip - 53108, Instrument Adapter, Starlock Interface - 55080, STEM POSITION VERIFICATION TOOL EXTENDED - 52873, STEM POSITION VERIFICATION TOOL HIP CT - 52872, Adapter for Cup Inserter - 41851, Instrument Calibration Matrix (Rev. 4) - 41874, 2-PIN DRILL TEMPLATE X-PRESS - 52425, 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 - 52424, Bone Fixator "2-Pin", X-Press - 52420, Reference Array T-Geometry, X-Press - 52410, Reference Array Y-Geometry, X-Press - 52411, BL Pointer, Square-Angled - 52852A, Gauge BL Pointer, Square Angled - 52852-10, BL Straight Cup Impactor Universal Shaft - 52858, BL 3.2MM PINDRIVER (AO INTERFACE) - 54932A, PINLESS FEMUR REFERENCE ARRAY - 52400-01A, BL POINTER STRAIGHT-EXTENDED - 52781A, GAUGE BL POINTER STRAIGHT-EXTENDED - 52781-10, HIP7 v7.0 - 04056481141981, Array Extension 75mm, X-Press - 52417, Gauge BL Pointer, Angled - 52565-10, BRAINLAB POINTER, ANGLED - 41784B

Authorization date:

2018-03-27