Biomet Comprehensive Segmental Revision System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

ZIMMER PTE. LTD.

Class:

Class C medical device

Manufactured by:

Biomet Orthopedics

Therapeutic area:

Orthopaedics

Therapeutic indications:

Indicated for: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Correction of functional deformity. 5. Oncology applications including bone loss due to tumor resection. When used in a proximal or total humeral replacement, system is also intended for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement which are unmanageable using other treatment methods. When used as a distal or total humeral replacement, it is also intended for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement which are unmanageable using other treatment methods. The system is intended for use with or without bone cement in the proximal shoulder. It is intended for use with bone cement in distal humeral and total humeral applications. Tissue Attachment Augments provide the option for tissue stabilization and attachment.

Product summary:

Device System Info:[Sterile Medical Device], Sterilised by Gamma Radiation; Models: COMPREHENSIVE SRS PROXIMAL BODY - SMALL 48MM - 211215, COMPREHENSIVE SRS PROXIMAL BODY - SMALL 58MM - 211216, COMPREHENSIVE SRS PROXIMAL BODY - SMALL 68MM - 211217, COMPREHENSIVE SRS PROXIMAL BODY - LARGE 42MM - 211218, COMPREHENSIVE SRS PROXIMAL BODY - LARGE 52MM - 211219, COMPREHENSIVE SRS PROXIMAL BODY - LARGE 62MM - 211220, COMPREHENSIVE SRS PROXIMAL BODY - TUMOR 51MM - 211221, COMPREHENSIVE SRS PROXIMAL BODY - TUMOR 61MM - 211222, COMPREHENSIVE SRS PROXIMAL BODY - TUMOR 71MM - 211223, COMPREHENSIVE SRS INTERCALARY SEGMENT WITH SCREW - 30MM - 211224, COMPREHENSIVE SRS INTERCALARY SEGMENT WITH SCREW - 60MM - 211225, COMPREHENSIVE SRS INTERCALARY SEGMENT WITH SCREW - 90MM - 211226, COMPREHENSIVE SRS INTERCALARY SEGMENT WITH SCREW - 120MM - 211227, COMPREHENSIVE SRS MODULAR REGENEREX AUGMENT - SMALL - 211228, COMPREHENSIVE SRS MODULAR REGENEREX AUGMENT - LARGE - 211229, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 6X75MM - 211230, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 8X75MM - 211231, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 10X75MM - 211232, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 12X75MM - 211233, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 14X75MM - 211234, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 6X100MM - 211235, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 8X100MM - 211236, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 10X100MM - 211237, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 12X100MM - 211238, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 14X100MM - 211239, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 4X150MM - 211240, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 6X150MM - 211241, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 8X150MM - 211242, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 10X150MM - 211243, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 12X150MM - 211244, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 6X200MM - 211246, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 8X200MM - 211247, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 10X200MM - 211248, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 12X200MM - 211249, COMPREHENSIVE SRS DISTAL BODY WITH SCREW- 50MM LEFT - 211250, COMPREHENSIVE SRS DISTAL BODY WITH SCREW - 60MM LEFT - 211251, COMPREHENSIVE SRS DISTAL BODY WITH SCREW - 70MM LEFT - 211252, COMPREHENSIVE SRS DISTAL BODY WITH SCREW- 50MM RIGHT - 211253, COMPREHENSIVE SRS DISTAL BODY WITH SCREW - 60MM RIGHT - 211254, COMPREHENSIVE SRS DISTAL BODY WITH SCREW - 70MM RIGHT - 211255, COMPREHENSIVE SRS SUPER EAS HUMERAL HEAD - 40X15MM - 211256, COMPREHENSIVE SRS HUMERAL COUPLER WITH SCREWS - 211257, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 9x75MM - 211258, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 9x100MM - 211259, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 9x150MM - 211260, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 9x200MM - 211261, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 11x75MM - 211262, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 11x100MM - 211263, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 11x150MM - 211264, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 11x200MM - 211265, COMPREHENSIVE SRS ANTI-ROTATION INTERCALARY SEGMENT - 30MM - 211266, COMPREHENSIVE SRS FLANGE WITH SCREWS - SMALL - 211269, COMPREHENSIVE SRS FLANGE WITH SCREWS - LARGE - 211270, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 16x75MM - 211274, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 16x100MM - 211275, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 14x150MM - 211276, COMPREHENSIVE SRS SUPER EAS HUMERAL HEAD - 44X17MM - 211277, COMPREHENSIVE SRS SUPER EAS HUMERAL HEAD - 48X19MM - 211278, COMPREHENSIVE SRS SUPER EAS HUMERAL HEAD - 54X22MM - 211279, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 18x75MM - 211280, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 20x75MM - 211281, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 18x100MM - 211282, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 16x150MM - 211283, COMPREHENSIVE SRS MODULAR STEM WITH SCREW - 14x200MM - 211284, COMPREHENSIVE SRS/NEXEL DISTAL BODY – 50MM LT - 110029824, COMPREHENSIVE SRS/NEXEL DISTAL BODY – 60MM LT - 110029825, COMPREHENSIVE SRS/NEXEL DISTAL BODY – 70MM LT - 110029826, COMPREHENSIVE SRS/NEXEL DISTAL BODY – 50MM RT - 110029938, COMPREHENSIVE SRS/NEXEL DISTAL BODY – 60MM RT - 110029939, COMPREHENSIVE SRS/NEXEL DISTAL BODY – 70MM RT - 110029940, Comprehensive SRS Instrument, Promixal Body Trial, Small, 48mm - 405101, Comprehensive SRS Instrument, Promixal Body Trial, Small 58mm - 405102, Comprehensive SRS Instrument, Promixal Body Trial, Small, 68mm - 405103, Comprehensive SRS Instrument, Promixal Body Trial, Large, 42m - 405104, Comprehensive SRS Instrument, Promixal Body Trial, Large, 52mm - 405105, Comprehensive SRS Instrument, Promixal Body Trial, Large, 62mm - 405106, Comprehensive SRS Instrument, Tumor Body Trial, 51mm - 405107, Comprehensive SRS Instrument, Tumor Body Trial, 61mm - 405108, Comprehensive SRS Instrument, Tumor Body Trial, 71mm - 405109, Comprehensive SRS Instrument, Intercalary Segment Trial, 30mm - 405110, Comprehensive SRS Instrument, Intercalary Segment Trial, 60mm - 405111, Comprehensive SRS Instrument, Intercalary Segment Trial, 90mm - 405112, Comprehensive SRS Instrument, Intercalary Segment Trial, 120mm - 405113, Comprehensive SRS Instrument, Broach/Stem Trial, 6mm X 75mm - 405116, Comprehensive SRS Instrument, Broach/Stem Trial, 8mm X 75mm - 405117, Comprehensive SRS Instrument, Broach/Stem Trial, 10mm X 75mm - 405118, Comprehensive SRS Instrument, Broach/Stem Trial, 12mm X 75mm - 405119, Comprehensive SRS Instrument, Broach/Stem Trial, 14mm X 75mm - 405120, Comprehensive SRS Instrument, Broach/Stem Trial, 6mm X 100mm - 405121, Comprehensive SRS Instrument, Broach/Stem Trial, 8mm X 100mm - 405122, Comprehensive SRS Instrument, Broach/Stem Trial, 10mm X 100mm - 405123, Comprehensive SRS Instrument, Broach/Stem Trial, 12mm X 100mm - 405124, Comprehensive SRS Instrument, Broach/Stem Trial, 14mm X 100mm - 405125, Comprehensive SRS Instrument, Broach/Stem Trial, 4mm X 150mm - 405126, Comprehensive SRS Instrument, Broach/Stem Trial, 6mm X 150mm - 405127, Comprehensive SRS Instrument, Broach/Stem Trial, 8mm X 150mm - 405128, Comprehensive SRS Instrument, Broach/Stem Trial, 10mm X 150mm - 405129, Comprehensive SRS Instrument, Broach/Stem Trial, 12mm X 150mm - 405130, Comprehensive SRS Instrument, Broach/Stem Trial, 4mm X 200mm - 405131, Comprehensive SRS Instrument, Broach/Stem Trial, 6mm X 200mm - 405132, Comprehensive SRS Instrument, Broach/Stem Trial, 8mm X 200mm - 405133, Comprehensive SRS Instrument, Broach/Stem Trial, 10mm X 200mm - 405134, Comprehensive SRS Instrument, Broach/Stem Trial, 12mm X 200mm - 405135, Comprehensive SRS Instrument, Distal Body Trial, Left, 50mm - 405136, Comprehensive SRS Instrument, Distal Body Trial, Left, 60mm - 405137, Comprehensive SRS Instrument, Left, Distal Body Trial, 70mm - 405138, Comprehensive SRS Instrument, Right, Distal Body Trialm 50mm - 405139, Comprehensive SRS Instrument, Right, Distal Body Trial, 60mm - 405140, Comprehensive SRS Instrument, Right, Distal Body Trial, 70mm - 405141, Comprehensive SRS Instrument, SEAS Head Trial, 40mm X 15mm - 405142, Comprehensive SRS Instrument, Total Humeral Coupler Trial - 405143, Comprehensive SRS Instrument, Broach/Stem Trial, 9mm X 75mm - 405169, Comprehensive SRS Instrument, Broach/Stem Trial, 9mm X 100mm - 405170, Comprehensive SRS Instrument, Broach/Stem Trial, 9mm X 150mm - 405171, Comprehensive SRS Instrument, Broach/Stem Trial, 9mm X 200mm - 405172, Comprehensive SRS Instrument, Broach/Stem Trial, 11mm X 75mm - 405173, Comprehensive SRS Instrument, Broach/Stem Trial, 11mm X 100mm - 405174, Comprehensive SRS Instrument, Broach/Stem Trial, 11mm X 150mm - 405175, Comprehensive SRS Instrument, Broach/Stem Trial, 11mm X 200mm - 405176, Comprehensive SRS Instrument, Anti-Rotation Segment Trial, 30mm - 405177, Comprehensive SRS Instrument, Flange Trial, Small - 405180, Comprehensive SRS Instrument, Flange Trial, Large - 405181, Comprehensive SRS Instrument, SEAS Head Trial, 44mm X 17mm - 405192, Comprehensive SRS Instrument, SEAS Head Trial, 48mm X 19mm - 405193, Comprehensive SRS Instrument, SEAS Head Trial, 54mm X 22mm - 405194, Comprehensive SRS Instrument, Broach/Stem Trial, 7mm X 75mm - 405195, Comprehensive SRS Instrument, Broach/Stem Trial, 13mm X 75mm - 405196, Comprehensive SRS Instrument, Broach/Stem Trial, 15mm X 75mm - 405197, Comprehensive SRS Instrument, Broach/Stem Trial, 16mm X 75mm - 405198, Comprehensive SRS Instrument, Broach/Stem Trial, 17mm X 75mm - 405199, Comprehensive SRS Instrument, Broach/Stem Trial, 18mm X 75mm - 405200, Comprehensive SRS Instrument, Broach/Stem Trial, 19mm X 75mm - 405201, Comprehensive SRS Instrument, Broach/Stem Trial, 20mm X 75mm - 405202, Comprehensive SRS Instrument, Broach/Stem Trial, 7mm X 100mm - 405203, Comprehensive SRS Instrument, Broach/Stem Trial, 13mm X 100mm - 405204, Comprehensive SRS Instrument, Broach/Stem Trial, 15mm X 100mm - 405205, Comprehensive SRS Instrument, Broach/Stem Trial, 16mm X 100mm - 405206, Comprehensive SRS Instrument, Broach/Stem Trial, 17mm X 100mm - 405207, Comprehensive SRS Instrument, Broach/Stem Trial, 18mm X 100mm - 405208, Comprehensive SRS Instrument, Broach/Stem Trial, 5mm X 150mm - 405209, Comprehensive SRS Instrument, Broach/Stem Trial, 7mm X 150mm - 405210, Comprehensive SRS Instrument, Broach/Stem Trial, 13mm X 150mm - 405211, Comprehensive SRS Instrument, Broach/Stem Trial, 14mm X 150mm - 405212, Comprehensive SRS Instrument, Broach/Stem Trial, 15mm X 150mm - 405213, Comprehensive SRS Instrument, Broach/Stem Trial, 16mm X 150mm - 405214, Comprehensive SRS Instrument, Broach/Stem Trial, 5mm X 200mm - 405215, Comprehensive SRS Instrument, Broach/Stem Trial, 7mm X 200mm - 405216, Comprehensive SRS Instrument, Broach/Stem Trial, 13mm X 200mm - 405217, Comprehensive SRS Instrument, Broach/Stem Trial, 14mm X 200mm - 405218, Comprehensive SRS/Nexel, Distal Body Trial, Right, 50mm - 110029259, Comprehensive SRS/Nexel, Distal Body Trial, Right, 50mm - 110029260, Comprehensive SRS/Nexel, Distal Body Trial, Right, 50mm - 110029261, Comprehensive SRS/Nexel, Distal Body Trial, Left 70mm - 110029941, Comprehensive SRS/Nexel, Distal Body Trial, Left, 60mm - 110029942, Comprehensive SRS/Nexel, Distal Body Trial, Left, 50mm - 110029943

Authorization date:

2018-10-22