DePuy Global Unite Shoulder System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

Johnson & Johnson International (Singapore) Pte Ltd

Class:

Class C medical device

Manufactured by:

DePuy (Ireland)

Therapeutic area:

Orthopaedics

Therapeutic indications:

The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total or hemi-shoulder arthroplasty for a severely painful and/or disabled joint; Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory; Irreducible 3- and 4-part fractures of the proximal humerus; Ununited humeral head fractures; Avascular necrosis of the humeral head; Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable. Hemi-shoulder arthroplasty is also indicated for Deformity and/or limited motion. The system also intended for cemented or uncemented reverse shoulder arthroplasty in treatment of Fracture of the proximal humerus; Irreducible 3- and 4-part fractures of the proximal humerus; Ununited humeral head fractures

Product summary:

Device System Info:[Sterile Medical Device], Gamma radiation; Models: GLOBAL UNITE REV STEM SZ 6 - 110006600, GLOBAL UNITE REV STEM SZ 8 - 110008600, GLOBAL UNITE REV STEM SZ 10 - 110010600, GLOBAL UNITE REV STEM SZ 12 - 110012600, GLOBAL UNITE STD STEM SZ 6 - 110006100, GLOBAL UNITE STD STEM SZ 8 - 110008100, GLOBAL UNITE STD STEM SZ 10 - 110010100, GLOBAL UNITE STD STEM SZ 12 - 110012100, GLOBAL UNITE STD STEM SZ 14 - 110014100, GLOBAL UNITE STD STEM SZ 16 - 110016100, Suture Collar 40mm - 110020100, Suture Collar 44mm - 110020200, Suture Collar 48mm - 110020300, Suture Collar 52mm - 110020400, Suture Collar 56mm - 110020500, Suture Collar 40mm Eccentric - 110020110, Suture Collar 44mm Eccentric - 110020210, Suture Collar 48mm Eccentric - 110020310, Suture Collar 52mm Eccentric - 110020410, Suture Collar 56mm Eccentric - 110020510, GLOBAL UNITE BODY SZ 10 -5 - 110030100, GLOBAL UNITE BODY SZ 10 0 - 110030110, GLOBAL UNITE BODY SZ 10 +5 - 110030120, GLOBAL UNITE BODY SZ 12 -5 - 110040100, GLOBAL UNITE BODY SZ 12 0 - 110040110, GLOBAL UNITE BODY SZ 12 +5 - 110040120, Humeral Head 40 x 15 - 110040500, Humeral Head 40 x 18 - 110040510, Humeral Head 40 x 15 Eccentric - 110040600, Humeral Head 40 x 18 Eccentric - 110040610, Humeral Head 44 x 15 - 110044500, Humeral Head 44 x 18 - 110044510, Humeral Head 44 x 21 - 110044520, Humeral Head 44 x 15 Eccentric - 110044600, Humeral Head 44 x 18 Eccentric - 110044610, Humeral Head 44 x 21 Eccentric - 110044620, Humeral Head 48 x 15 - 110048500, Humeral Head 48 x 18 - 110048510, Humeral Head 48 x 21 - 110048520, Humeral Head 48 x 15 Eccentric - 110048600, Humeral Head 48 x 18 Eccentric - 110048610, Humeral Head 48 x 21 Eccentric - 110048620, GLOBAL UNITE BODY SZ 14 -5 - 110050100, GLOBAL UNITE BODY SZ 14 0 - 110050110, GLOBAL UNITE BODY SZ 14 +5 - 110050120, Humeral Head 52 x 15 - 110052500, Humeral Head 52 x 18 - 110052510, Humeral Head 52 x 21 - 110052520, Humeral Head 52 x 15 Eccentric - 110052600, Humeral Head 52 x 18 Eccentric - 110052610, Humeral Head 52 x 21 Eccentric - 110052620, Humeral Head 56 x 18 - 110056510, Humeral Head 56 x 21 - 110056520, Humeral Head 56 x 18 Eccentric - 110056610, Humeral Head 56 x 21 Eccentric - 110056620, GLOBAL UNITE BODY SZ 16 -5 - 110060100, GLOBAL UNITE BODY SZ 16 0 - 110060110, GLOBAL UNITE BODY SZ 16 +5 - 110060120, Epiphyseal Reamer 1 - 210070600, Epiphyseal Reamer 2 - 210070610, Bullet Tip Reamer 6mm - 212811006, Bullet Tip Reamer 7mm - 212811007, Bullet Tip Reamer 8mm - 212811008, Bullet Tip Reamer 9mm - 212811009, Bullet Tip Reamer 10mm - 212811010, Bullet Tip Reamer 11mm - 212811011, Bullet Tip Reamer 12mm - 212811012, Bullet Tip Reamer 13mm - 212811013, Bullet Tip Reamer 14mm - 212811014, Bullet Tip Reamer 15mm - 212811015, Bullet Tip Reamer 16mm - 212811016, Stem Wrench 6 – 8mm - 230784003, Reverse Epiphyseal Holder - 210070700, Ratchet T-Handle - 212861070, Humeral Head Distractor - 213001120, 3.2mm Osteotomy Guide Pin – Long - 213020000, GLOBAL UNITE STD STEM SZ 6 TR - 210006100, GLOBAL UNITE STD STEM SZ 8 TR - 210008100, GLOBAL UNITE STD STEM SZ 10 TR - 210010100, GLOBAL UNITE STD STEM SZ 12 TR - 210012100, GLOBAL UNITE STD STEM SZ 14 TR - 210014100, GLOBAL UNITE STD STEM SZ 16 TR - 210016100, GLOBAL UNITE REV STEM SZ 6 TR - 210006600, GLOBAL UNITE REV STEM SZ 8 TR - 210008600, GLOBAL UNITE REV STEM SZ 10 TR - 210010600, GLOBAL UNITE REV STEM SZ 12 TR - 210012600, Suture Collar 40mm Trial - 210020100, Suture Collar 44mm Trial - 210020200, Suture Collar 48mm Trial - 210020300, Suture Collar 52mm Trial - 210020400, Suture Collar 56mm Trial - 210020500, Suture Collar 40mm Eccentric Trial - 210020110, Suture Collar 44mm Eccentric Trial - 210020210, Suture Collar 48mm Eccentric Trial - 210020310, Suture Collar 52mm Eccentric Trial - 210020410, Suture Collar 56mm Eccentric Trial - 210020510, GLOBAL UNITE BODY SZ 10 -5 TR - 210030000, GLOBAL UNITE BODY SZ 10 0 TR - 210030010, GLOBAL UNITE BODY SZ 10 +5 TR - 210030020, GLOBAL UNITE BODY SZ 12 -5 TR - 210040000, GLOBAL UNITE BODY SZ 12 0 TR - 210040010, GLOBAL UNITE BODY SZ 12 +5 TR - 210040020, Humeral Head 40 x 15 Trial - 210040500, Humeral Head 40 x 18 Trial - 210040510, Humeral Head 40 x 15 Eccentric Trial - 210040600, Humeral Head 40 x 18 Eccentric Trial - 210040610, Humeral Head 44 x 15 Trial - 210044500, Humeral Head 44 x 18 Trial - 210044510, Humeral Head 44 x 21 Trial - 210044520, Humeral Head 44 x 15 Eccentric Trial - 210044600, Humeral Head 44 x 18 Eccentric Trial - 210044610, Humeral Head 44 x 21 Eccentric Trial - 210044620, Humeral Head 48 x 15 Trial - 210048500, Humeral Head 48 x 18 Trial - 210048510, Humeral Head 48 x 21 Trial - 210048520, Humeral Head 48 x 15 Eccentric Trial - 210048600, Humeral Head 48 x 18 Eccentric Trial - 210048610, Humeral Head 48 x 21 Eccentric Trial - 210048620, GLOBAL UNITE BODY SZ 14 -5 TR - 210050000, GLOBAL UNITE BODY SZ 14 0 TR - 210050010, GLOBAL UNITE BODY SZ 14 +5 TR - 210050020, Humeral Head 52 x 15 Trial - 210052500, Humeral Head 52 x 18 Trial - 210052510, Humeral Head 52 x 21 Trial - 210052520, Humeral Head 52 x 15 Eccentric Trial - 210052600, Humeral Head 52 x 18 Eccentric Trial - 210052610, Humeral Head 52 x 21 Eccentric Trial - 210052620, Humeral Head 56 x 18 Trial - 210056510, Humeral Head 56 x 21 Trial - 210056520, Humeral Head 56 x 18 Eccentric Trial - 210056610, Humeral Head 56 x 21 Eccentric Trial - 210056620, GLOBAL UNITE BODY SZ 16 -5 TR - 210060000, GLOBAL UNITE BODY SZ 16 0 TR - 210060010, GLOBAL UNITE BODY SZ 16 +5 TR - 210060020, Global UNITE Head Gauge - 210001019, Impaction Stand - 210001022, Implant Holder - 210001035, Fracture Positioning Jig - 210001036, 3.5mm Hex Screwdriver - 210070150, 4.0mm Female Hex Screwdriver - 210070155, Reverse Epiphyseal Holder - 210070250, Greater Tuberosity Forceps - 210070300, Epiphyseal Reamer Guide - 210070410, Epiphyseal Sizer 1 - 210070500, Epiphyseal Sizer 2 - 210070510, Global Unite Reverse FX EPI Center Porocoat - 140720101, Global Unite Reverse FX EPI Left Porocoat - 140720102, Global Unite Reverse FX EPI Right Porocoat - 140720103, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 40 x 12 - 210011400, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 40 x 15 - 210011401, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 40 x 18 - 210011402, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 44 x 12 - 210011440, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 44 x 15 - 210011441, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 44 x 18 - 210011442, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 44 x 21 - 210011443, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 48 x 15 - 210011481, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 48 x 18 - 210011482, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 48 x 21 - 210011483, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 52 x 15 - 210011521, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 52 x 18 - 210011522, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 52 x 21 - 210011523, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 56 x 18 - 210011562, GLOBAL UNITE TRIAL HUMERAL HEAD, STANDARD 56 x 21 - 210011563, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 40 x 15 - 210022401, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 40 x 18 - 210022402, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 44 x 15 - 210022441, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 44 x 18 - 210022442, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 44 x 21 - 210022443, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 48 x 15 - 210022481, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 48 x 18 - 210022482, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 48 x 21 - 210022483, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 52 x 15 - 210022521, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 52 x 18 - 210022522, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 52 x 21 - 210022523, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 56 x 18 - 210022562, GLOBAL UNITE TRIAL HUMERAL HEAD, ECCENTRIC 56 x 21 - 210022563

Authorization date:

2014-07-10