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HSA · registration DE0018497

Zimmer CPT Hip System

SingaporeOrthopaedicsClass CZimmer Inc
Official record identity
Registration number
DE0018497
Model name
VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 22 MM DIAMETER STANDARD +0 MM NECK LENGTH; VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 22 MM DIA. -2.0 MM NECK LENGTH; VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 22 MM DIA. +3.0 MM NECK LENGTH; VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 28 MM DIAMETER -3.5 MM NECK LENGTH; VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 28 MM DIAMETER STANDARD +0 MM NECK LENGTH; VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPE 28 MM DIAMETER +3.5 MM NECK LENGTH; VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 28 MM DIAMETER +7 MM NECK LENGTH; VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 28 MM DIAMETER +10.5 MM NECK LENGTH; CPT® HIP SYSTEM CONE PROVISIONAL; CPT® HIP SYSTEM CONE PROVISIONAL EXTENDED NECK OFFSET; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 0, 105mm Stem Length, Packaged with Revision Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 0, 105mm Stem Length, Packaged with Revision Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 1, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 1, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 2, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 2, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 2, 180mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extra Extended Offset, Size 2, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 3, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 3, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 3, 180mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extra Extended Offset, Size 3, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 4, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 4, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 4, 200mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 4, 230mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 4, 260mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extra Extended Offset, Size 4, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 5, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 5, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extra Extended Offset, Size 5, 130mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Valgus Neck (VN), Size 2, 180mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Valgus Neck (VN), Size 3, 180mm Stem Length, Packaged with Standard Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extra Small, 85mm Stem Length, Packaged w/ Revision Centralizer; CPT Hip System, Femoral Stem, 12/14 Neck Taper, Small, 95mm Stem Length, Packaged w/ Revision Centralizer; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL STANDARD OFFSET SIZE 0; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL STANDARD OFFSET SIZE 1; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL STANDARD OFFSET SIZE 2; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL STANDARD OFFSET SIZE 3; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL STANDARD OFFSET SIZE 4; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL STANDARD OFFSET SIZE 5; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION STEM PROVISIONAL EXTRA SMALL; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION STEM PROVISIONAL SMALL; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTENDED OFFSET SIZE 0; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTENDED OFFSET SIZE 1; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTENDED OFFSET SIZE 2; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTENDED OFFSET SIZE 3; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTENDED OFFSET SIZE 4; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTENDED OFFSET SIZE 5; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTRA EXTENDED OFFSET SIZE 2; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTRA EXTENDED OFFSET SIZE 3; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTRA EXTENDED OFFSET SIZE 4; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTRA EXTENDED OFFSET SIZE 5; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION - REVISION CONE PROVISIONAL VALGUS NECK (VN) SIZE 2; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION - REVISION CONE PROVISIONAL VALGUS NECK (VN) SIZE 3; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION STEM PROVISIONAL EXTENDED OFFSET SIZE 4 230 MM LENGTH; CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION STEM PROVISIONAL EXTENDED OFFSET SIZE 4 260 MM LENGTH; CPT Hip System Cement Pressurizer, Small; CPT Hip System Cement Pressurizer, Medium; CPT Hip System Cement Pressurizer, Large; CPT Hip System Cement Pressurizer, Small, Quantity - 5; CPT Hip System Cement Pressurizer, Medium, Quantity - 5; CPT Hip System Cement Pressurizer, Large, Quantity - 5; CPT Hip System Centralizer For use w/CPT Femoral Stems; CPT Hip System Revision Centralizer For use w/CPT Femoral Stems; CPT Hip System Femoral Pressurizer Seal, Large, Blue; CPT Hip System Femoral Pressurizer Seal, Small, Natural; CPT Hip System Cement Restrictor Seal
Model identifier
00-7895-022-02; 00-7895-022-20; 00-7895-022-30; 00-7895-028-01; 00-7895-028-02; 00-7895-028-03; 00-7895-028-04; 00-7895-028-05; 00-8011-101-00; 00-8011-101-20; 00-8114-000-00; 00-8114-000-10; 00-8114-001-00; 00-8114-001-10; 00-8114-002-00; 00-8114-002-10; 00-8114-002-18; 00-8114-002-30; 00-8114-003-00; 00-8114-003-10; 00-8114-003-18; 00-8114-003-30; 00-8114-004-00; 00-8114-004-10; 00-8114-004-20; 00-8114-004-23; 00-8114-004-26; 00-8114-004-30; 00-8114-005-00; 00-8114-005-10; 00-8114-005-30; 00-8114-012-18; 00-8114-013-18; 00-8114-040-00; 00-8114-050-00; 00-8334-015-00; 00-8334-015-01; 00-8334-015-02; 00-8334-015-03; 00-8334-015-04; 00-8334-015-05; 00-8334-015-40; 00-8334-015-50; 00-8334-020-00; 00-8334-020-01; 00-8334-020-02; 00-8334-020-03; 00-8334-020-04; 00-8334-020-05; 00-8334-025-02; 00-8334-025-03; 00-8334-025-04; 00-8334-025-05; 00-8334-026-02; 00-8334-026-03; 00-8334-070-25; 00-8334-070-26; 00-8334-084-01; 00-8334-084-02; 00-8334-084-03; 00-8334-084-51; 00-8334-084-52; 00-8334-084-53; 32-8333-055-00; 32-8333-056-00; 32-8334-010-01; 32-8334-010-02; 32-8334-012-00
Registration date
August 25, 2016
Classification
Risk class
Class C
Official value: CLASS C
Published category
Orthopaedics
Published parties
Product owner
Zimmer Inc
Registrant / registration holder
ZIMMER PTE. LTD.
Official description

The Zimmer CPT® Hip System is indicated for cemented use in: • Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. • Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis. • Patients suffering from disability due to previous fusion. • Patients with previously failed endoprostheses and/or total hip components in the affected extremity. • Patients with acute femoral neck fractures.

Additional source fields
Product owner address
1800 West Centre Street, Warsaw IN 46580, United States
Registrant address
401 COMMONWEALTH DRIVE, #06-03, HAW PAR TECHNO CENTRE, Singapore 149598
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.