Mako System Japanese approval scope, electronic package insert, 8th revision

Japanese approval for the Mako System covers total hip, total knee and partial knee arthroplasty only. No spine and no shoulder application appears in the approved indications as of the eighth-revision package insert of August 2023, and hip resurfacing and hemiarthroplasty are listed as contraindicated. The approved scope, not the fee, bounds what Mako can be sold into in Japan.

Supporting location 承認番号 22900BZX00325000, approved indications and contraindicated applications

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