DePuy Delta Xtend™ Reverse Shoulder System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

Johnson & Johnson International (Singapore) Pte Ltd

Class:

Class D medical device

Manufactured by:

DePuy (Ireland)

Therapeutic area:

Orthopaedics

Therapeutic indications:

The Delta Xtend Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: -severe arthropathy and/or; -a previous failed joint replacement and/or; -Fracture-dislocations, of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed Delta Xtend Reverse Shoulder.

Product summary:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], system consisting of the following: metal monobloc humeral implant, metal humeral head, glenosphere, metaglene, humeral cup and optional metal humeral spacer. sterilise by gamma irradiation.; Models: DELTA Xtend™ Monobloc Hum Cemented Epiphysis 1 Dia 8 Std - 130708100, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 1 Dia 8 Long - 130708110, DELTA Xtend™ Cementless Modular Humeral stem Dia 10 - 130710000, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 1 Dia 10 Std - 130710100, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 1 Dia 10 Long - 130710110, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 2 Dia 10 Std - 130710200, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 2 Dia 10 Long - 130710210, DELTA Xtend™ Cementless Modular Humeral stem Dia 12 - 130712000, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 1 Dia 12 Std - 130712100, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 1 Dia 12 Long - 130712110, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 2 Dia 12 Std - 130712200, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 2 Dia 12 Long - 130712210, DELTA Xtend™ Cementless Modular Humeral stem Dia 14 - 130714000, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 1 Dia 14 Std - 130714100, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 1 Dia 14 Long - 130714110, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 2 Dia 14 Std - 130714200, DELTA Xtend™ Monobloc Hum Cemented Epiphysis 2 Dia 14 Long - 130714210, DELTA Xtend™ Cementless Modular Humeral stem Dia 16 - 130716000, DELTA Xtend™ Cementless Modular Centered Epiphysis Sz 1 - 130720101, DELTA Xtend™ Cementless Modular Eccentric Epiphysis Sz 1 Left - 130720102, DELTA Xtend™ Cementless Modular Eccentric Epiphysis Sz 1 Right - 130720103, DELTA Xtend™ Cementless Modular Centered Epiphysis Sz 2 - 130720201, DELTA Xtend™ Cementless Modular Eccentric Epiphysis Sz 2 Left - 130720202, DELTA Xtend™ Cementless Modular Eccentric Epiphysis Sz 2 Right - 130720203, DELTA Xtend™ Humeral Spacer +9mm - 130730009, DELTA Xtend™ High Mobility Humeral PE Cup Dia 38+3mm - 130738003, DELTA Xtend™ High Mobility Humeral PE Cup Dia 38+6mm - 130738006, DELTA Xtend™ High Mobility Humeral PE Cup Dia 38+9mm - 130738009, DELTA Xtend™ Retentive Humeral PE Cup Dia 38 +6mm - 130738106, DELTA Xtend™ Standard Humeral PE Cup Dia 38 +3mm - 130738203, DELTA Xtend™ Standard Humeral PE Cup Dia 38 +6mm - 130738206, DELTA Xtend™ Standard Humeral PE Cup Dia 38 +9mm - 130738209, DELTA Xtend™ High Mobility Humeral PE Cup Dia 42+3mm - 130742003, DELTA Xtend™ High Mobility Humeral PE Cup Dia 42+6mm - 130742006, DELTA Xtend™ High Mobility Humeral PE Cup Dia 42+9mm - 130742009, DELTA Xtend™ Retentive Humeral PE Cup Dia 42 +6mm - 130742106, DELTA Xtend™ Standard Humeral PE Cup Dia 42 +3mm - 130742203, DELTA Xtend™ Standard Humeral PE Cup Dia 42 +6mm - 130742206, DELTA Xtend™ Standard Humeral PE Cup Dia 42 +9mm - 130742209, DELTA Xtend™ Delta Xtend CTA Head Dia 48 x 21 mm - 130748021, DELTA Xtend™ Delta Xtend CTA Head Dia 48 x 26 mm - 130748026, DELTA Xtend™ Delta Xtend CTA Head Dia 52 x 21 mm - 130752021, DELTA Xtend™ Delta Xtend CTA Head Dia 52 x 26 mm - 130752026, DELTA Xtend™ Cementless Metaglene - 130760000, DELTA Xtend™ Eccentric Glenosphere Dia 38mm - 130760038, DELTA Xtend™ Eccentric Glenosphere Dia 42mm - 130760042, DELTA Xtend™ Standard Glenosphere Dia 38mm - 130760138, DELTA Xtend™ Standard Glenosphere Dia 42mm - 130760142, DELTA Xtend™ Non Locking Metaglene Screw Dia 4.5 Lg 18mm - 130770018, DELTA Xtend™ Non Locking Metaglene Screw Dia 4.5 Lg 24mm - 130770024, DELTA Xtend™ Non Locking Metaglene Screw Dia 4.5 Lg 30mm - 130770030, DELTA Xtend™ Non Locking Metaglene Screw Dia 4.5 Lg 36mm - 130770036, DELTA Xtend™ Non Locking Metaglene Screw Dia 4.5 Lg 42mm - 130770042, DELTA Xtend™ Locking Metaglene Screw Dia 4.5 Lg 24mm - 130790024, DELTA Xtend™ Locking Metaglene Screw Dia 4.5 Lg 30mm - 130790030, DELTA Xtend™ Locking Metaglene Screw Dia 4.5 Lg 36mm - 130790036, DELTA Xtend™ Locking Metaglene Screw Dia 4.5 Lg 42mm - 130790042, DELTA Xtend™ Locking Metaglene Screw Dia 4.5 Lg 48mm - 130790048, DELTA CTA™ Hybrid Humeral Cup Epi 36 Dia 38 +3mm - 140738203, DELTA CTA™ Hybrid Humeral Cup Epi 36 Dia 38 +6mm - 140738206, DELTA CTA™ Hybrid Humeral Cup Epi 36 Dia 38 +9mm - 140738209, DELTA CTA™ Hybrid Retentive Humeral Cup Epi 36 Dia 38 +6mm - 140738106, DELTA CTA™ Hybrid Humeral Cup Epi 36 Dia 42 +3mm - 140742203, DELTA CTA™ Hybrid Humeral Cup Epi 36 Dia 42 +6mm - 140742206, DELTA CTA™ Hybrid Humeral Cup Epi 36 Dia 42 +9mm - 140742209, DELTA Xtend™ Cementless Metaglene +10mm - 140760010, DELTA Xtend™ Cementless Metaglene +15mm - 140760015, DELTA CTA™ Lateralized Humeral Cup, Ø 36, +3mm - 4CHL336, DELTA CTA™ Lateralized Humeral Cup, Ø 42, +3mm - 4CHL342, DELTA CTA™ Lateralized Humeral Cup, Ø 36, +6mm - 4CHL636, DELTA CTA™ Lateralized Retentive Humeral Cup, Ø 36, +6mm - 4CHL636R, DELTA CTA™ Lateralized Humeral Cup, Ø 42, +6mm - 4CHL642, DELTA CTA™ Lateralized Retentive Humeral Cup, Ø 42, +6mm - 4CHL642R, DELTA CTA™ Lateralized Humeral Cup, Ø 36, +9mm - 4CHL936, DELTA CTA™ Lateralized Humeral Cup, Ø 42, +9mm - 4CHL942, DELTA CTA™ Glenosphere, Ø 36mm - GSC236, DELTA CTA™ Glenosphere, Ø 42mm - GSC242, DELTA CTA™ Humeral Lengthener, Ø 36mm, +9mm - RTH236, DELTA CTA™ Humeral Lengthener, Ø 42mm, +9mm - RTH242, DELTA CTA™ Humeral Head, Ø 36 Height, 0mm - TIH036, DELTA CTA™ Humeral Head, Ø 42 Height, 0mm - TIH042, DELTA CTA™ Humeral Head, Ø 36 Height, +4mm - TIH436, DELTA CTA™ Humeral Head, Ø 42 Height, +4mm - TIH442, Hudson Adaptor - 152400000, AML® EXCEL™ Femoral/Humeral Head Impactor - 200165000, Femoral Hd Impactor Repl Tip - 200166000, GLOBAL™ ADVANTAGE® Reamer 6mm - 212801006, GLOBAL™ ADVANTAGE® Reamer 8mm - 212801008, GLOBAL™ ADVANTAGE® Reamer 10mm - 212801010, GLOBAL™ ADVANTAGE® Reamer 12mm - 212801012, GLOBAL™ ADVANTAGE® Reamer 14mm - 212801014, GLOBAL™ ADVANTAGE® Reamer 16mm - 212801016, GLOBAL FX Positioning Jig - 212801035, GLOBAL™ ADVANTAGE® T-Handle - 212861070, DELTA Xtend™ Delta Xtend Broach Handle - 230701030, DELTA Xtend™ Goniometer - 230701031, DELTA Xtend™ Plate For Broach Handle - 230701032, DELTA Xtend™ Monobloc Hum Trial EPI 1 Dia 8 Std - 230708100, DELTA Xtend™ Monobloc Hum Trial EPI 1 Dia 8 Long - 230708110, DELTA Xtend™ Modular Humeral Stem Trial Dia 10mm - 230710001, DELTA Xtend™ Monobloc Hum Trial EPI 1 Dia 10 Std - 230710100, DELTA Xtend™ Monobloc Hum Trial EPI 1 Dia 10 Long - 230710110, DELTA Xtend™ Monobloc Hum Trial EPI 2 Dia 10 Std - 230710200, DELTA Xtend™ Monobloc Hum Trial EPI 2 Dia 10 Long - 230710210, DELTA Xtend™ Modular Humeral Stem Trial Dia 12mm - 230712001, DELTA Xtend™ Monobloc Hum Trial EPI 1 Dia 12 Std - 230712100, DELTA Xtend™ Monobloc Hum Trial EPI 1 Dia 12 Long - 230712110, DELTA Xtend™ Monobloc Hum Trial EPI 2 Dia 12 Std - 230712200, DELTA Xtend™ Monobloc Hum Trial EPI 2 Dia 12 Long - 230712210, DELTA Xtend™ Modular Humeral Stem Trial Dia 14mm - 230714001, DELTA Xtend™ Monobloc Hum Trial EPI 1 Dia 14 Std - 230714100, DELTA Xtend™ Monobloc Hum Trial EPI 1 Dia 14 Long - 230714110, DELTA Xtend™ Monobloc Hum Trial EPI 2 Dia 14 Std - 230714200, DELTA Xtend™ Monobloc Hum Trial EPI 2 Dia 14 Long - 230714210, DELTA Xtend™ Modular Humeral Stem Trial Dia 16mm - 230716001, DELTA Xtend™ Modular Centered Epiphysis Trial Sz 1 - 230720101, DELTA Xtend™ Modular Eccentric Epiphysis Trial Sz 1 Left - 230720102, DELTA Xtend™ Modular Eccentric Epiphysis Trial Sz 1 Right - 230720103, DELTA Xtend™ Modular Centered Epiphysis Trial Sz 2 - 230720201, DELTA Xtend™ Modular Eccentric Epiphysis Trial Sz 2 Left - 230720202, DELTA Xtend™ Modular Eccentric Epiphysis Trial Sz 2 Right - 230720203, DELTA Xtend™ Humeral Spacer Trial +9mm - 230730009, DELTA Xtend™ High Mobility Humeral Cup Trial Dia 38 +3mm - 230738303, DELTA Xtend™ High Mobility Humeral Cup Trial Dia 38 +6mm - 230738306, DELTA Xtend™ High Mobility Humeral Cup Trial Dia 38 +9mm - 230738309, DELTA Xtend™ Standard Humeral Cup Trial Dia 38 +3mm - 230738403, DELTA Xtend™ Standard Humeral Cup Trial Dia 38 +6mm - 230738406, DELTA Xtend™ Standard Humeral Cup Trial Dia 38 +9mm - 230738409, DELTA Xtend™ Retentive Humeral Cup Trial Dia 38 +6mm - 230738506, DELTA Xtend™ High Mobility Humeral Cup Trial Dia 42 +3mm - 230742303, DELTA Xtend™ High Mobility Humeral Cup Trial Dia 42 +6mm - 230742306, DELTA Xtend™ High Mobility Humeral Cup Trial Dia 42 +9mm - 230742309, DELTA Xtend™ Standard Humeral Cup Trial Dia 42 +3mm - 230742403, DELTA Xtend™ Standard Humeral Cup Trial Dia 42 +6mm - 230742406, DELTA Xtend™ Standard Humeral Cup Trial Dia 42 +9mm - 230742409, DELTA Xtend™ Retentive Humeral Cup Trial Dia 42 +6mm - 230742506, DELTA Xtend™ Delta Xtend CTA Head Trial Dia 48 x 21mm - 230748121, DELTA Xtend™ Delta Xtend CTA Head Trial Dia 48 x 26mm - 230748126, DELTA Xtend™ Delta Xtend CTA Head Trial Dia 52 x 21mm - 230752121, DELTA Xtend™ Delta Xtend CTA Head Trial Dia 52 x 26mm - 230752126, DELTA Xtend™ Eccentric Glenosphere Trial Dia 38mm - 230760038, DELTA Xtend™ Eccentric Glenosphere Trial Dia 42mm - 230760042, DELTA Xtend™ Standard Glenosphere Trial Dia 38mm - 230760138, DELTA Xtend™ Standard Glenosphere Trial Dia 42mm - 230760142, DELTA Xtend™ Cup Impactor Tip - 230767000, DELTA Xtend™ Spacer Impactor Tip - 230768000, DELTA Xtend™ Handle For Cutting Guide Dia 8mm - 230770008, DELTA Xtend™ Handle For Cutting Guide Dia 10mm - 230770010, DELTA Xtend™ Handle For Cutting Guide Dia 12mm - 230770012, DELTA Xtend™ Handle For Cutting Guide Dia 14mm - 230770014, DELTA Xtend™ Handle For Cutting Guide Dia 16mm - 230770016, DELTA Xtend™ Orientation Pin - 230771000, DELTA Xtend™ Delto Pectoral Cutting Guide - 230772003, DELTA Xtend™ Delto Pectoral Cutting Plate - 230772004, DELTA Xtend™ Superior Lateral Cutting Guide - 230773003, DELTA Xtend™ Superior Lateral Cutting Plate - 230773004, DELTA Xtend™ Holder For Proximal Reaming Guides - 230774001, DELTA Xtend™ Internal Rod For Reaming Guide Holder - 230774002, DELTA Xtend™ Proximal Reaming Guide Dia 8mm - 230774008, DELTA Xtend™ Proximal Reaming Guide Dia 10mm - 230774010, DELTA Xtend™ Proximal Reaming Guide Dia 12mm - 230774012, DELTA Xtend™ Proximal Reaming Guide Dia 14mm - 230774014, DELTA Xtend™ Proximal Reaming Guide Dia 16mm - 230774016, DELTA Xtend™ Centered Proximal Reaming Adaptator - 230776000, DELTA Xtend™ Eccentric Proximal Reaming Adaptator Sz 1 - 230776001, DELTA Xtend™ Eccentric Proximal Reaming Adaptator Sz 2 - 230776002, DELTA Xtend™ Epiphyseal Disk For Modular Implant Sz 1 - 230777003, DELTA Xtend™ Epiphyseal Disk For Modular Implant Sz 2 - 230777004, DELTA Xtend™ Proximal Reamer For Modular Implant Sz 1 - 230778003, DELTA Xtend™ Proximal Reamer For Modular Implant Sz 2 - 230778004, DELTA Xtend™ Humeral Broach Dia 10 - 230779010, DELTA Xtend™ Humeral Broach Dia 12 - 230779012, DELTA Xtend™ Humeral Broach Dia 14 - 230779014, DELTA Xtend™ Humeral Broach Dia 16 - 230779016, DELTA Xtend™ Epiphyseal Disk For Monobloc Implant Sz 1 - 230780003, DELTA Xtend™ Epiphyseal Disk For Monobloc Implant Sz 2 - 230780004, DELTA Xtend™ Proximal Reamer For Monobloc Implant Sz 1 - 230781003, DELTA Xtend™ Proximal Reamer For Monobloc Implant Sz 2 - 230781004, DELTA Xtend™ Delta CTA Head Reaming Guide - 230782001, DELTA Xtend™ Delta CTA Head Reamer - 230782003, DELTA Xtend™ Humeral Implant Driver - 230783000, DELTA Xtend™ Locking Wrench For Modular Implant Dia 10-12mm - 230784001, DELTA Xtend™ Locking Wrench For Modular Implant Dia 14-16mm - 230784002, DELTA Xtend™ Humeral Resection Protecting Plate - 230785000, DELTA Xtend™ V Shape Glenoid Retractor - 230786002, DELTA Xtend™ Metaglene Holder Internal Rod - 230787002, DELTA Xtend™ Metaglene Positioner Plate - 230787003, DELTA Xtend™ Metaglene Central Guide Pin Dia 2.5mm - 230787004, DELTA Xtend™ Metaglene Holder - 230787005, DELTA Xtend™ Glenoid Resurfacing Reamer Dia 27mm - 230788027, DELTA Xtend™ Glenoid Manual Reamer Dia 42mm - 230788242, DELTA Xtend™ Glenoid Reamer Level Checker - 230788300, DELTA Xtend™ Glenoid Cannulated Stop Drill Dia 7.5mm - 230789000, DELTA Xtend™ Glenoid Drill Guide Dia 2.5mm - 230790003, DELTA Xtend™ Screw Guide Pin Dia 1.2 Lg 150mm x5 - 230790004, DELTA Xtend™ Drill Bit Dia 2.5 Lg 120mm - 230790005, DELTA Xtend™ Screw Depth Gauge - 230791001, DELTA Xtend™ Locking Screwdriver Main Body - 230792003, DELTA Xtend™ Locking Screwdriver Internal Rod - 230792004, DELTA Xtend™ 3.5mm Cannulated Hex Screwdriver - 230793000, DELTA Xtend™ Glenosphere Orientation Guide - 230795000, DELTA Xtend™ Glenosphere Guide Pin Ø 1,5 x 300mm - 230796000, DELTA Xtend™ Cup Extraction Clamp - 230799001, DELTA Xtend™ Extraction T-Handle - 230799002, DELTA Xtend™ Pin Extractor - 230799004, No label for the containers - 230799901, No label for the containers - 230799905, No label for the containers - 230799906, No label for the containers - 230799909, No label for the containers - 230799910, No label for the containers - 230799913, No label for the containers - 230799917, No label for the containers - 230799922, No label for the containers - 230799923, No label for the containers - 230799924, No label for the containers - 230799927, No label for the containers - 230799928, No label for the containers - 230799931, No label for the containers - 230799932, No label for the containers - 230799934, No label for the containers - 230799935, No label for the containers - 230799936, No label for the containers - 230799938, No label for the containers - 230799939, No label for the containers - 230799940, DELTA CTA REV RET TRIAL CUP EPI36 D 38 +6mm - 240738106, DELTA CTA REV TRIAL CUP EPI36 D 38 +3mm - 240738203, DELTA CTA REV TRIAL CUP EPI36 D 38 +6mm - 240738206, DELTA CTA REV TRIAL CUP EPI36 D 38 +9mm - 240738209, DELTA CTA REV TRIAL CUP EPI36 D 42 +3mm - 240742203, DELTA CTA REV TRIAL CUP EPI36 D 42 +6mm - 240742206, DELTA CTA REV TRIAL CUP EPI36 D 42 +9mm - 240742209, DELTA XTEND GLENOID CANNULATED STOP DRILL DIA 7.5MM +10MM - 240789010, DELTA XTEND GLENOID CANNULATED STOP DRILL DIA 7.5MM +15MM - 240789015, LEGEND II Fixation Pin - 249095000, DELTA CTA TRIAL LATERALIZED RETENTIVE HUMERAL CUP - A5260, DELTA CTA TRIAL LATERALIZED HUMERAL CUP - A5261, DELTA CTA TRIAL LATERALIZED RETENTIVE HUMERAL CUP - A5263, DELTA CTA TRIAL LATERALIZED HUMERAL CUP - A5264, DELTA CTA TRIAL LATERALIZED HUMERAL CUP - A5466, DELTA CTA TRIAL LATERALIZED HUMERAL CUP - A5467, DELTA CTA TRIAL LATERALIZED HUMERAL CUP - A5468, DELTA CTA TRIAL LATERALIZED HUMERAL CUP - A5469, No label for the X-ray template - CALQ2000, DELTA CTA™ Humeral Head Extractor - ETH001, DELTA CTA™ Impactor For Humeral Stem - ITH003, Inertia Mass - MAI001, Extractor Sleeve - MDE001, DELTA CTA TRIAL HUMERAL LENGTHENER - REH236, DELTA CTA TRIAL HUMERAL LENGTHENER - REH242, DELTA CTA TRIAL HUMERAL HEAD - TEH442, DELTA CTA TRIAL HUMERAL HEAD - TEH036, DELTA CTA TRIAL HUMERAL HEAD - TEH042, DELTA CTA TRIAL HUMERAL HEAD - TEH436, DELTA CTA HEXAGONAL SCREWDRIVER - TEP025, Delta Modular Head™ Trial 32mm - 267010F, Delta Modular Head™ Trial 36mm - 267012F, Delta Modular Head™ Trial 40mm - 267014F, Delta Modular Head™ Trial 44mm - 267016F

Authorization date:

2011-04-11