Executive briefing
Mako full platform — Japan
Since your last visit: 3 answers revised, 2 decisions resolved, 41 sources rechecked.
Posture
The single sentence that frames every answer below.
Japan is the one market that pays for the robot. A dedicated code, K082-8, pays ¥421,900 for robotic-assisted TKA, ¥45,000 more than the conventional code, with surgical fees effective 1 June 2026. The open question is no longer access but whether the premium clears break-even at typical Japanese case volumes.
- Q1
Coverage
Yes / OpenEstablished[CORRECTED]Japan is the only market in this study with a dedicated robotic premium.
Robotic TKA technical fee: ¥421,900 (K082-8)
high confidenceCurrent· 27 Aug 2026Changed — v4
Next action
Confirm the facility standards and any minimum case volume against the primary MHLW notice.Market Access Lead, Japan · 31 Oct 2026
2 sources
Expand detail view - Q2
Cost offset
Partial / ConditionalEstablished[DK][INFERENCE][CHANGED]The premium is real but modelled below break-even at typical Japanese case volumes.
Premium over conventional: +¥45,000
high confidenceOverdue· 3 Sep 2026Not independently establishedChanged — v4
Next action
Commission a Japanese facility-level cost analysis with a published method, sized to support an FY2028 submission.HEOR Lead, Japan · 19 Dec 2026
8 sources
Expand detail view - Q3
Policy lever
Partial / ConditionalEstablished[INFERENCE]The premium was won inside the biennial cycle; the next window is FY2028.
Next revision window: FY2028 cycle
medium confidenceCurrent· 27 Aug 2026Next action
Put the FY2028 submission milestones into the watchlist with a named owner.Market Access Lead, Japan · 30 Nov 2026
1 source
Expand detail view - Q4
Payment treatment
Yes / OpenEstablished[CORRECTED]Separate, and in the strongest sense: the robot has its own procedure code.
Payment treatment: Dedicated robotic procedure code
high confidenceCurrent· 24 Aug 2026Changed — v3
Next action
Record the packaging position in the Product Brief and close the separate-payment workstream for Japan.Market Access Lead, Japan · 1 Oct 2026
1 source
Expand detail view - Q5
Dossier status
Yes / OpenEstablished[CORRECTED][UNVERIFIED]The evidence package was assembled, submitted and accepted. It won the premium.
Dossier status against the independent literature: Premium accepted for FY2026; the independent trials show parity, not superiority
medium confidenceFreshness not checked· 27 Aug 2026Changed — v4
Next action
Resolve the ambiguous study citation, then scope the FY2028 refresh around the missing economics.HEOR Lead, Japan · 17 Oct 2026
6 sources
Expand detail view - Q6
Prevalence
Context onlyEstablished[UNVERIFIED]Population burden is large and is not the constraint on adoption.
Knee OA prevalence: 20.6 per cent symptomatic, 39.3 per cent radiographic (ROAD 4th wave, 2015-2016)
medium confidenceFreshness not checked· 3 Sep 2026Not yet researchedNext action
Re-attach the prevalence citation to its primary cohort study, or mark prevalence not applicable for this product.Analyst, Japan · 24 Oct 2026
3 sources
Expand detail view - Q7
Ambulatory share
Yes / OpenEstablished[CHANGED]Roughly 175,000 registered knee and hip replacements a year, on an opt-in registry that undercounts.
Registered TKA and THA FY2023, and hospitals of 200 beds or more: 87,773 and 87,455; 2,398 of 8,060 hospitals
medium confidenceOverdue· 26 Aug 2026Changed — v4
Next action
Pull the claims-based national knee replacement count and record the method difference against the registry.Analyst, Japan · 3 Oct 2026
6 sources
Expand detail view - Q8
Installed base
Context onlyEstablished[CHANGED][NEW][UNVERIFIED]A contested field: rival arthroplasty robots are cleared, and one is already insurance-covered.
Robot-assisted share of primary THA: 7.69 per cent FY2024, up from 5.78 per cent FY2023
medium confidenceOverdue· 27 Aug 2026Changed — v4
Next action
Add an independent Japanese installed-base source to the evidence acquisition plan, and confirm the competitor coverage date at source.Analyst, Japan · 14 Nov 2026
9 sources
Expand detail view
Every question expands in place — select one for the evidence, implications, metrics, sources and version history behind its verdict. Opening one collapses the rest; the strip above keeps all eight verdicts in view.
Paid, with a dedicated code
K082-8 is the robotic procedure code itself.
Premium below break-even at typical volume
Modelled, not measured. The input set is internal.
Package assembled and accepted
It won the FY2026 premium. FY2028 needs a fresh one.
Fee schedule and registry are primary
Prevalence citation still to be re-attached.
These four statuses are reported independently. No overall score is calculated.