Regulatory filing
K242121 (us_fda)
FDA 510(k) clearance for the Monogram mBos / semi-autonomous total-knee-arthroplasty system; reported March 2025.
fda 510k · cleared · decided 2025-03-14
Machine-readable surfaces
- Markdown mirror: /regulatory-filings/fda-monogram-mbos-clearance-2025.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/filings/048b93df-b668-4376-8c40-98d6fefe081d
- Revision history: /regulatory-filings/fda-monogram-mbos-clearance-2025/history
- Data documentation: /data
Key facts
- Jurisdiction
- us_fda
- Filing type
- fda 510k
- Status
- cleared
- Filing number
- K242121
- Filing date
- 2024-07-19
- Decision date
- 2025-03-14
- Verification posture
- reported
- Cap-flag notes
- Filing number not yet captured; clearance reported March 2025. Upgrade to verified when the K-number is confirmed.
Applicant
Covered models (1)
Sources (1)
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Identity
048b93df-b668-4376-8c40-98d6fefe081d