Singapore HSA registration DE0503105

Biomet Persona Partial Knee System

Singapore·CLASS C·Biomet Orthopedics·Registered May 16, 2019

Device classification

Device Class: CLASS C
Medical Speciality Area: Orthopaedics

Registration information

Registration Number: DE0503105
Registration Date: May 16, 2019
Change Notification Approval Date: September 28, 2022
Retention Due Date: May 15, 2025

Product description

The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications: - Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis; - traumatic arthritis; - previous tibial condyle or plateau fractures with loss of anatomy or function; - varus deformities; and - revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged. The Persona Partial Knee System is a single use implant intended for implantation with bone cement.

Product Owner

Name: Biomet Orthopedics
Short Name: Biomet Orthopedics
Address: 56 East Bell Drive, P.O. Box 587, Warsaw, Indiana, 46581, UNITED STATES

Registrant

Name: ZIMMER PTE. LTD.
Address: 401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598

Importer

Name: ZIMMER PTE. LTD.
Address: 401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598

Model information

Model Name(s): Persona Partial Knee Femoral Peg Drill Persona Partial Knee Articular Surface Provisional, Medial, Size C, 8mm Persona Partial Knee Articular Surface Provisional, Medial Size C, 9mm Persona Partial Knee Articular Surface Provisional, Medial,Size C, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size C, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size C, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size C, 14mm Persona Partial Knee Articular Surface Provisional, Medial, Size D, 8mm Persona Partial Knee Articular Surface Provisional, Medial Size D, 9mm Persona Partial Knee Articular Surface Provisional, Medial, Size D, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size D, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size D, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size D, 14mm Persona Partial Knee Articular Surface Provisional, Medial, Size E, 8mm Persona Partial Knee Articular Surface Provisional, Medial Size E, 9mm Persona Partial Knee Articular Surface Provisional, Medial, Size E, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size E, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size E, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size E, 14mm Persona Partial Knee Articular Surface Provisional, Medial, Size F, 8mm Persona Partial Knee Articular Surface Provisional, Medial Size F, 9mm Persona Partial Knee Articular Surface Provisional, Medial, Size F, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size F, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size F, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size F, 14mm Persona Partial Knee Articular Surface Provisional, Medial, Size G, 8mm Persona Partial Knee Articular Surface Provisional, Medial Size G, 9mm Persona Partial Knee Articular Surface Provisional, Medial, Size G, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size G, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size G, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size G, 14mm Persona Partial Knee Articular Surface Provisional, Medial, Size H, 8mm Persona Partial Knee Articular Surface Provisional, Medial, Size H, 9mm Persona Partial Knee Articular Surface Provisional, Medial, Size H, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size H, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size H, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size H, 14mm Persona Partial Knee Articular Surface Provisional, Medial, Size J, 8mm Persona Partial Knee Articular Surface Provisional, Medial, Size J, 9mm Persona Partial Knee Articular Surface Provisional, Medial, Size J, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size J, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size J, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size J, 14mm Persona Partial Knee VE Articular Surface, Left Medial, Size C, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size C, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size C, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size C, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size C, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size C, 14 mm Persona Partial Knee VE Articular Surface, Left Medial, Size D, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size D, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size D, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size D, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size D, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size D, 14 mm Persona Partial Knee VE Articular Surface, Left Medial, Size E, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size E, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size E, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size E, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size E, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size E, 14 mm Persona Partial Knee VE Articular Surface, Left Medial, Size F, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size F, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size F, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size F, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size F, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size F, 14 mm Persona Partial Knee VE Articular Surface, Left Medial, Size G, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size G, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size G, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size G, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size G, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size G, 14 mm Persona Partial Knee VE Articular Surface, Left Medial, Size H, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size H, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size H, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size H, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size H, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size H, 14 mm Persona Partial Knee VE Articular Surface, Left Medial, Size J, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size J, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size J, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size J, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size J, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size J, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size C, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size C, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size C, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size C, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size C, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size C, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size D, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size D, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size D, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size D, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size D, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size D, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size E, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size E, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size E, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size E, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size E, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size E, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size F, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size F, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size F, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size F, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size F, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size F, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size G, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size G, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size G, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size G, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size G, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size G, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size H, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size H, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size H, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size H, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size H, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size H, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size J, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size J, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size J, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size J, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size J, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size J, 14 mm Persona Partial Knee Articular Surface Inserter Tip Persona Partial Knee System Tibia, Left Medial, Size C Persona Partial Knee System Tibia, Right Medial, Size C Persona Partial Knee System Tibia, Left Medial, Size D Persona Partial Knee System Tibia, Right Medial, Size D Persona Partial Knee System Tibia, Left Medial, Size E Persona Partial Knee System Tibia, Right Medial, Size E Persona Partial Knee System Tibia, Left Medial, Size F Persona Partial Knee System Tibia, Right Medial, Size F Persona Partial Knee System Tibia, Left Medial, Size G Persona Partial Knee System Tibia, Right Medial, Size G Persona Partial Knee System Tibia, Left Medial, Size H Persona Partial Knee System Tibia, Right Medial, Size H Persona Partial Knee System Tibia, Left Medial, Size J Persona Partial Knee System Tibia, Right Medial, Size J Persona Partial Knee Tibial Provisional Left Medial, Size C Persona Partial Knee Tibial Provisional Right Medial, Size C Persona Partial Knee Tibial Provisional Left Medial, Size D Persona Partial Knee Tibial Provisional Right Medial, Size D Persona Partial Knee Tibial Provisional Left Medial, Size E Persona Partial Knee Tibial Provisional Right Medial, Size E Persona Partial Knee Tibial Provisional Left Medial, Size F Persona Partial Knee Tibial Provisional Right Medial, Size F Persona Partial Knee Tibial Provisional Left Medial, Size G Persona Partial Knee Tibial Provisional Right Medial, Size G Persona Partial Knee Tibial Provisional Left Medial, Size H Persona Partial Knee Tibial Provisional Right Medial, Size H Persona Partial Knee Tibial Provisional Left Medial, Size J Persona Partial Knee Tibial Provisional Right Medial, Size J Persona Partial Knee Cemented Femoral, Left Medial, Size 1 Persona Partial Knee Cemented Femoral, Right Medial, Size 1 Persona Partial Knee Cemented Femoral, Left Medial, Size 2 Persona Partial Knee Cemented Femoral, Right Medial, Size 2 Persona Partial Knee Cemented Femoral, Left Medial, Size 3 Persona Partial Knee Cemented Femoral, Right Medial, Size 3 Persona Partial Knee Cemented Femoral, Left Medial, Size 4 Persona Partial Knee Cemented Femoral, Right Medial, Size 4 Persona Partial Knee Cemented Femoral, Left Medial, Size 5 Persona Partial Knee Cemented Femoral, Right Medial, Size 5 Persona Partial Knee Cemented Femoral, Left Medial, Size 6 Persona Partial Knee Cemented Femoral, Right Medial, Size 6 Persona Partial Knee Cemented Femoral, Left Medial, Size 7 Persona Partial Knee Cemented Femoral, Right Medial, Size 7 Persona Partial Knee Cemented Femoral, Left Medial, Size 8 Persona Partial Knee Cemented Femoral, Right Medial, Size 8 Persona Partial Knee Femoral Provisional Left Medial, Size 1 Persona Partial Knee Femoral Provisional Right Medial, Size 1 Persona Partial Knee Femoral Provisional Left Medial, Size 2 Persona Partial Knee Femoral Provisional Right Medial, Size 2 Persona Partial Knee Femoral Provisional Left Medial, Size 3 Persona Partial Knee Femoral Provisional Right Medial, Size 3 Persona Partial Knee Femoral Provisional Left Medial, Size 4 Persona Partial Knee Femoral Provisional Right Medial, Size 4 Persona Partial Knee Femoral Provisional Left Medial, Size 5 Persona Partial Knee Femoral Provisional Right Medial, Size 5 Persona Partial Knee Femoral Provisional Left Medial, Size 6 Persona Partial Knee Femoral Provisional Right Medial, Size 6 Persona Partial Knee Femoral Provisional Left Medial, Size 7 Persona Partial Knee Femoral Provisional Right Medial, Size 7 Persona Partial Knee Femoral Provisional Left Medial, Size 8 Persona Partial Knee Femoral Provisional Right Medial, Size 8
Model Identifier(s): 42-5099-042-00 42-5181-003-08 42-5181-003-09 42-5181-003-10 42-5181-003-11 42-5181-003-12 42-5181-003-14 42-5181-004-08 42-5181-004-09 42-5181-004-10 42-5181-004-11 42-5181-004-12 42-5181-004-14 42-5181-005-08 42-5181-005-09 42-5181-005-10 42-5181-005-11 42-5181-005-12 42-5181-005-14 42-5181-006-08 42-5181-006-09 42-5181-006-10 42-5181-006-11 42-5181-006-12 42-5181-006-14 42-5181-007-08 42-5181-007-09 42-5181-007-10 42-5181-007-11 42-5181-007-12 42-5181-007-14 42-5181-008-08 42-5181-008-09 42-5181-008-10 42-5181-008-11 42-5181-008-12 42-5181-008-14 42-5181-009-08 42-5181-009-09 42-5181-009-10 42-5181-009-11 42-5181-009-12 42-5181-009-14 42-5182-003-08 42-5182-003-09 42-5182-003-10 42-5182-003-11 42-5182-003-12 42-5182-003-14 42-5182-004-08 42-5182-004-09 42-5182-004-10 42-5182-004-11 42-5182-004-12 42-5182-004-14 42-5182-005-08 42-5182-005-09 42-5182-005-10 42-5182-005-11 42-5182-005-12 42-5182-005-14 42-5182-006-08 42-5182-006-09 42-5182-006-10 42-5182-006-11 42-5182-006-12 42-5182-006-14 42-5182-007-08 42-5182-007-09 42-5182-007-10 42-5182-007-11 42-5182-007-12 42-5182-007-14 42-5182-008-08 42-5182-008-09 42-5182-008-10 42-5182-008-11 42-5182-008-12 42-5182-008-14 42-5182-009-08 42-5182-009-09 42-5182-009-10 42-5182-009-11 42-5182-009-12 42-5182-009-14 42-5282-003-08 42-5282-003-09 42-5282-003-10 42-5282-003-11 42-5282-003-12 42-5282-003-14 42-5282-004-08 42-5282-004-09 42-5282-004-10 42-5282-004-11 42-5282-004-12 42-5282-004-14 42-5282-005-08 42-5282-005-09 42-5282-005-10 42-5282-005-11 42-5282-005-12 42-5282-005-14 42-5282-006-08 42-5282-006-09 42-5282-006-10 42-5282-006-11 42-5282-006-12 42-5282-006-14 42-5282-007-08 42-5282-007-09 42-5282-007-10 42-5282-007-11 42-5282-007-12 42-5282-007-14 42-5282-008-08 42-5282-008-09 42-5282-008-10 42-5282-008-11 42-5282-008-12 42-5282-008-14 42-5282-009-08 42-5282-009-09 42-5282-009-10 42-5282-009-11 42-5282-009-12 42-5282-009-14 42-5299-003-01 42-5380-003-01 42-5380-003-02 42-5380-004-01 42-5380-004-02 42-5380-005-01 42-5380-005-02 42-5380-006-01 42-5380-006-02 42-5380-007-01 42-5380-007-02 42-5380-008-01 42-5380-008-02 42-5380-009-01 42-5380-009-02 42-5381-003-01 42-5381-003-02 42-5381-004-01 42-5381-004-02 42-5381-005-01 42-5381-005-02 42-5381-006-01 42-5381-006-02 42-5381-007-01 42-5381-007-02 42-5381-008-01 42-5381-008-02 42-5381-009-01 42-5381-009-02 42-5580-001-01 42-5580-001-02 42-5580-002-01 42-5580-002-02 42-5580-003-01 42-5580-003-02 42-5580-004-01 42-5580-004-02 42-5580-005-01 42-5580-005-02 42-5580-006-01 42-5580-006-02 42-5580-007-01 42-5580-007-02 42-5580-008-01 42-5580-008-02 42-5581-001-01 42-5581-001-02 42-5581-002-01 42-5581-002-02 42-5581-003-01 42-5581-003-02 42-5581-004-01 42-5581-004-02 42-5581-005-01 42-5581-005-02 42-5581-006-01 42-5581-006-02 42-5581-007-01 42-5581-007-02 42-5581-008-01 42-5581-008-02

About this record

Access comprehensive regulatory information for Biomet Persona Partial Knee System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503105 and owned by Biomet Orthopedics. The device was registered on May 16, 2019.

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