FDA Events for Monogram Orthopaedics (MGRM)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Monogram Orthopaedics (MGRM).
Over the past two years, Monogram Orthopaedics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
mBos. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
mBos TKA System - FDA Regulatory Timeline and Events
mBos TKA System is a drug developed by Monogram Orthopaedics for the following indication: device.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- mBos TKA System
- Announced Date:
- April 29, 2025
- Indication:
- device
Announcement
Monogram Technologies announced it has obtained regulatory approval from India's Central Drugs Standard Control Organization ("CDSCO") to import its mBôs TKA system to conduct a 102-patient, multi-center clinical investigation evaluating the safety and effectiveness of the Monogram TKA System.
AI Summary
Monogram Technologies, an AI-driven robotics company in orthopedic surgery, announced that it has received regulatory approval from India’s Central Drugs Standard Control Organization (CDSCO) to import its mBôs TKA system. This approval allows the company to conduct a multi-center clinical investigation in India, involving 102 knee replacement procedures. The clinical trial is set to evaluate the safety and effectiveness of the Monogram TKA System over a three-month follow-up period and will be conducted in collaboration with one of the world's largest orthopedic hospital groups, Shalby Hospitals.
Patient enrollment is expected to begin soon, with the first live patient surgeries anticipated within 90 business days. This milestone is a key step for Monogram, as the trial will help demonstrate the performance of their advanced robotic system in real surgical settings, ultimately reinforcing the company’s commitment to advancing orthopedic care and innovation globally.
Read Announcement- Drug:
- mBos TKA System
- Announced Date:
- March 17, 2025
- Indication:
- device
Announcement
Monogram Technologies announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance
AI Summary
Monogram Technologies Inc. recently received 510(k) clearance from the FDA for its Monogram mBôs TKA System, a robotic-assisted platform designed for total knee arthroplasty. The clearance, granted under the Federal Food, Drug, and Cosmetic Act, allows Monogram to market the system, which uses patient-specific, CT-based imaging and advanced predictive navigation tools for more personalized and accurate surgery.
CEO Ben Sexson highlighted the system’s performance and its potential impact on orthopedic robotics. Monogram expects that partnering with key surgeons in select regions will showcase the system’s real-world benefits and help establish a strong market presence. The clearance marks a significant step in the company’s efforts to expand its footprint in robotic-assisted procedures and improve surgical outcomes for patients.
Read Announcement
Monogram Orthopaedics FDA Events - Frequently Asked Questions
As of now, Monogram Orthopaedics (MGRM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Monogram Orthopaedics (MGRM) has reported FDA regulatory activity for mBos TKA System.
The most recent FDA-related event for Monogram Orthopaedics occurred on April 29, 2025, involving mBos TKA System. The update was categorized as "Regulatory Update," with the company reporting: "Monogram Technologies announced it has obtained regulatory approval from India's Central Drugs Standard Control Organization ("CDSCO") to import its mBôs TKA system to conduct a 102-patient, multi-center clinical investigation evaluating the safety and effectiveness of the Monogram TKA System."
Currently, Monogram Orthopaedics has one therapy (mBos TKA System) targeting the following condition: device.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:MGRM) was last updated on 7/12/2025 by MarketBeat.com Staff
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