mBos TKA System

The Monogram mBos TKA System is a robotic total-knee-arthroplasty platform from Monogram Technologies, a Zimmer Biomet subsidiary since October 2025. It is the autonomy-boundary case of DEPLOY's surgical cluster: unlike the AI-augmented, surgeon-controlled systems (Stryker Mako, Smith+Nephew CORI, Zimmer Biomet ROSA), where the surgeon makes the cuts, the cleared mBos is semi-autonomous, with a robotic arm (built on a KUKA arm) executing the bone cuts itself under AI control within a surgeon-approved, patient-specific CT-based plan and active surgeon supervision. There is no consumer price: it is pre-commercial enterprise surgical equipment that has not sold any units. Several verified-vs-claimed cap-flags matter. It received FDA 510(k) clearance on March 17, 2025, but the exact K-number could not be independently verified, and the 'semi-autonomous' characterization is sourced to Zimmer Biomet and trade coverage rather than the FDA letter (Monogram's own clearance release described it more softly as robotic-assisted TKA). A separate fully-autonomous, hands-free, saw-based version is not FDA cleared and remains in development, targeted around late 2027 or 2028; its first live-patient procedure (July 26, 2025, Ahmedabad, India) was under an India CDSCO 102-procedure investigation, not US FDA, a single index case with no verified peer-reviewed outcomes. Monogram was founded by orthopedic surgeon Dr. Doug Unis (chief medical officer and founder, not CEO; the pre-acquisition CEO was Benjamin Sexson) and was acquired by Zimmer Biomet at about $168M enterprise value plus contingent value rights, with commercialization alongside Zimmer Biomet implants targeted for early 2027. The registry records it at research maturity: cleared but pre-commercial, with its headline fully-autonomous capability still in development.

Readiness

mBos TKA System is internal use only (not for retail), no capability claims are on file, 1 verified deployment is on file, and no incidents are on record.

Availability

internal-only

Internal use only (not for retail).

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Price honesty

no-price

No price points on file for mBos TKA System.

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Capability honesty

no-claims

No reviewed capability claims on file for mBos TKA System.

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Real-world use

research

Maturity: research. 1 verified deployment in the registry.

see evidence →

Safety record

no-incidents

No incidents on record. 1 verified deployment on file.

What it claims to do

No reviewed capability claims on file.

Price

No reviewed price points on file.

Real-world use

• Ahmedabad2025-07-26

Safety record

No incidents on record. 1 verified deployment on file.

Privacy

No privacy practices disclosed or on file for mBos TKA System.

Specs

arms

KUKA arm

notes

• AI-as-primary boundary (the reason for this entry): The autonomy-boundary case of the orthopedic sub-cohort. CLEARED mBos = SEMI-AUTONOMOUS: the robotic arm executes the bone cut under AI control within a surgeon-approved CT plan + supervision (the robot cuts, not the surgeon) - genuinely AI-primary for the cutting step, distinct from the AI-AUGMENTED surgeon-controlled Mako/CORI/ROSA (where the surgeon makes the cut). The fully-autonomous hands-free version (no surgeon hands-on) is a further step but is NOT cleared / in development.
• Corporate / acquisition: Monogram Orthopaedics (founded 2015 by orthopedic surgeon Dr. Doug Unis, who is CMO + founder + largest shareholder, NOT CEO - pre-acquisition CEO was Benjamin Sexson) renamed Monogram Technologies Inc (May 15 2024; NASDAQ: MGRM). Acquired by Zimmer Biomet (NYSE: ZBH): agreement Jul 11 2025, CLOSED Oct 7 2025 (~$4.04/share cash, ~$168M enterprise value, + non-tradeable CVRs up to $12.37/share through 2030). Now a ZB subsidiary (delisted); this is where ZB's autonomy line lives, distinct from the surgeon-controlled ROSA cohort.
• FDA pathway (cap-flag): 510(k) clearance granted Mar 17 2025 for the mBos TKA System (mPress implants separately cleared). CAP-FLAGS: the exact K-number + FDA product code could NOT be independently verified (FDA accessdata blocked); the 'semi-autonomous' label is sourced to Zimmer Biomet + trade press, NOT verbatim from the FDA letter (Monogram's own clearance PR used softer 'robotic-assisted TKA'); the FULLY-autonomous version is NOT US-cleared.
• Clinical / commercial (cap-flag; maturity=research): PRE-COMMERCIAL: 'not sold any units yet' (Jul 2025); commercialization with ZB implants gated to ~early 2027 post-integration. First fully-autonomous live-patient TKA Jul 26 2025 at Krishna Shalby Hospital, Ahmedabad, India under India CDSCO approval (102-procedure investigation) - NOT US FDA, a single index case with no verified peer-reviewed outcomes ('flawlessly executed' is company PR). Do NOT conflate the ~early-2027 (semi-auto commercialization) and ~late-2027/2028 (fully-auto) dates. maturity=research (cleared but pre-commercial, headline autonomy in-development).
• Surgical cluster axis extension: Adds a 4th architectural axis to the surgical cluster: autonomy-boundary verification posture (autonomous vs AI-augmented vs assistive), alongside the FDA-clearance axis (Wave 1), clinical-domain axis (Wave 2), and the orthopedic sub-cohort triangle (Wave 3: Mako/CORI/ROSA, all AI-augmented surgeon-controlled).

specs

Monogram mBos TKA System: robotic total-knee-arthroplasty platform. CT-based patient-specific pre-operative planning + AI/predictive navigation + a robotic arm (built on a KUKA arm) that EXECUTES the bone cuts and insertion paths for Monogram's mPress press-fit implants (separately FDA-cleared). The cleared system is SEMI-AUTONOMOUS: the robot performs the cut under AI control within a surgeon-approved CT-based plan and active surgeon supervision - distinct from the surgeon-hands-on Mako/CORI/ROSA. A separate FULLY-autonomous, hands-free, foot-pedal-activated saw-based version is NOT FDA cleared and remains in development (~late 2027/2028). Made by Monogram Technologies, a Zimmer Biomet subsidiary since Oct 2025.

formFactor

surgical (robotic total-knee-arthroplasty; AUTONOMY-BOUNDARY case - AI-primary semi-autonomous bone-cutting, distinct from surgeon-controlled assistance)

fda_clearance

510(k) March 17, 2025

visualization

CT-based

clearance_body

FDA

procedure_types

total-knee-arthroplasty

What's under the hood

No brain on file for mBos TKA System.

Frequently asked questions

Is the mBos TKA System actually available for purchase?

Not available to consumers. In internal use by Monogram Technologies.Source: Monogram FDA 510(k) clearance for the mBos TKA System (Mar 17 2025; mPress implants)

What does the mBos TKA System cost?

Not announced.

Where is the mBos TKA System being used?

mBos TKA System is in use at: Ahmedabad (2025-07-26).Source: Monogram Technologies Announces World's First Fully Autonomous Saw-Based Robotic Knee Replacement Surgery

Is the mBos TKA System safe?

No incidents on record across 1 verified deployment.

How does the mBos TKA System handle privacy?

No privacy practices disclosed or on file for mBos TKA System.

Who makes the mBos TKA System?

mBos TKA System is made by Monogram Technologies, based in unknown.Source: Monogram FDA 510(k) clearance for the mBos TKA System (Mar 17 2025; mPress implants)

Video

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Sources

1. Monogram FDA 510(k) clearance for the mBos TKA System (Mar 17 2025; mPress implants) · https://www.biospace.com/press-releases/monogram-technologies-announces-fda-510k-clearance-for-the-monogram-mbostm-tka-system ↗
2. Zimmer Biomet completes acquisition of Monogram Technologies (closed Oct 7 2025; $4.04/share + CVR up to $12.37; commercialization with ZB implants ~early 2027) · https://www.prnewswire.com/news-releases/zimmer-biomet-completes-acquisition-of-monogram-technologies-302577035.html ↗
3. Monogram first fully-autonomous saw-based live-patient TKA (Jul 26 2025; Ahmedabad India, CDSCO 102-procedure trial, NOT US FDA) · https://www.globenewswire.com/news-release/2025/07/29/3123344/0/en/Monogram-Technologies-Announces-World-s-First-Fully-Autonomous-Saw-Based-Robotic-Knee-Replacement-Surgery.html ↗
4. Why Zimmer Biomet acquired Monogram (mBos 'not sold any units yet'; fully-autonomous uncleared, ~late 2027/2028 target) · https://www.medtechdive.com/news/zimmer-why-acquire-monogram-robotics/753204/ ↗
5. Monogram Technologies Q1 2025 results (corporate state; renamed Monogram Technologies May 2024; NASDAQ: MGRM) · https://www.globenewswire.com/news-release/2025/05/14/3081555/0/en/Monogram-Technologies-Reports-First-Quarter-2025-Financial-Results.html ↗
6. Monogram Technologies Form 8-K (acquisition closing-period; SEC) · https://www.sec.gov/Archives/edgar/data/0001769759/000110465925097530/tm2527971d1_ex99-1.htm ↗
7. Zimmer Biomet Form 8-K exhibit (Monogram acquisition announcement; SEC) · https://www.sec.gov/Archives/edgar/data/0001136869/000119312525158442/d76564dex992.htm ↗
8. Monogram Technologies official YouTube (@MonogramTechnologies), embedded under standard YouTube embed terms. oEmbed author_url verified 2026-06-04. Maker product video; surgeon-teleoperated/assisted system, not autonomous. · https://www.youtube.com/watch?v=j0OQk8mT-bs ↗ · 2026-06-04
9. Monogram Technologies Inc. Form 8-K - FY2025 · https://www.sec.gov/Archives/edgar/data/0001769759/000110465925071470/tm2521919d1_ex99-1.htm ↗ · 2025-07-29