Maxx Orthopedics Inc
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring. To maintain equal site distribution per device, patient recruitment will include up to a total of twenty (20) registry sites and thirty (30) primary TKA candidates per site / surgeon for a total of 600 registry patients. A total of no more than 200 patients across all sites will be recruited per level of constraint (e.g.: 200 CR, 200:PS, 200:UC) for this registry with a 10-month accrual target from study…
INCLUSION CRITERIA: Candidates for this registry must meet ALL of the following criteria: * Patient is \> 18 years of age * Patient has failed attempts at non-operative conservative therapy * Patient has participated in the informed consent process and signed an IRB approved informed consent * Patient is scheduled to undergo unilateral or bilateral primary TKA of the knee EXCLUSION CRITERIA: Candidates will be excluded from the evaluation if ANY of the following apply: * Patients with previous TKA, UKA, HTO or knee fusion of the indicated knee * Patients that have undergone previous surge…
Post-Market Surveillance of the Freedom Total Knee System for Primary TKA
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