{"id":"078e765e-b40f-43c4-a23e-50643a23484e","companyId":"9fb91ced-a678-45d5-943a-9b58948b42a5","modelName":"mBos TKA System","slug":"monogram-mbos","description":"The Monogram mBos TKA System is Monogram's robotic total-knee-arthroplasty platform, recorded in the surgical form factor as the autonomy-boundary case of the orthopedic sub-cohort: unlike the AI-augmented surgeon-controlled systems Stryker Mako, Smith+Nephew CORI, and Zimmer Biomet ROSA, where the surgeon makes the cuts, the cleared mBos is semi-autonomous, with the robotic arm executing the bone cuts itself under AI control within a surgeon-approved, patient-specific CT-based plan and active surgeon supervision. It pairs CT-based pre-operative planning and predictive navigation with a robotic arm, built on a KUKA arm, that executes optimized cutting and insertion paths for Monogram's mPress press-fit implants. The system received FDA 510(k) clearance on March 17, 2025, although the precise cleared indication wording and the 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, which Monogram's own clearance release described 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 was performed on July 26, 2025 at Krishna Shalby Hospital in Ahmedabad, India under an India CDSCO approval for a 102-procedure investigation, not under US FDA, as a single index case without verified peer-reviewed outcomes. Made by Monogram Technologies, founded in 2015 as Monogram Orthopaedics by orthopedic surgeon Dr. Doug Unis, who is chief medical officer and founder rather than chief executive, with Benjamin Sexson as the pre-acquisition CEO, and renamed Monogram Technologies in May 2024 trading on NASDAQ as MGRM, the company was acquired by Zimmer Biomet with the deal closing October 7, 2025 at about 168 million dollars enterprise value plus contingent value rights, making Monogram a Zimmer Biomet subsidiary with commercialization alongside Zimmer Biomet implants targeted for early 2027. The registry records the system at research maturity because it is cleared but pre-commercial with no units sold, and its headline fully-autonomous capability remains in development.","formFactor":"surgical","maturityStage":"research","lifecycleState":"active","supersededByModelId":null,"specs":{"notes":[{"label":"AI-as-primary boundary (the reason for this entry)","value":"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."},{"label":"Corporate / acquisition","value":"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."},{"label":"FDA pathway (cap-flag)","value":"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."},{"label":"Clinical / commercial (cap-flag; maturity=research)","value":"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)."},{"label":"Surgical cluster axis extension","value":"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)"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.biospace.com/press-releases/monogram-technologies-announces-fda-510k-clearance-for-the-monogram-mbostm-tka-system","title":"Monogram FDA 510(k) clearance for the mBos TKA System (Mar 17 2025; mPress implants)","sourceName":"BioSpace (Monogram PR)"},{"url":"https://www.prnewswire.com/news-releases/zimmer-biomet-completes-acquisition-of-monogram-technologies-302577035.html","title":"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)","sourceName":"PR Newswire / Zimmer Biomet"},{"url":"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","title":"Monogram first fully-autonomous saw-based live-patient TKA (Jul 26 2025; Ahmedabad India, CDSCO 102-procedure trial, NOT US FDA)","sourceName":"GlobeNewswire (Monogram)"},{"url":"https://www.medtechdive.com/news/zimmer-why-acquire-monogram-robotics/753204/","title":"Why Zimmer Biomet acquired Monogram (mBos 'not sold any units yet'; fully-autonomous uncleared, ~late 2027/2028 target)","sourceName":"MedTech Dive"},{"url":"https://www.globenewswire.com/news-release/2025/05/14/3081555/0/en/Monogram-Technologies-Reports-First-Quarter-2025-Financial-Results.html","title":"Monogram Technologies Q1 2025 results (corporate state; renamed Monogram Technologies May 2024; NASDAQ: MGRM)","sourceName":"GlobeNewswire (Monogram)"},{"url":"https://www.sec.gov/Archives/edgar/data/0001769759/000110465925097530/tm2527971d1_ex99-1.htm","title":"Monogram Technologies Form 8-K (acquisition closing-period; SEC)","sourceName":"SEC EDGAR"},{"url":"https://www.sec.gov/Archives/edgar/data/0001136869/000119312525158442/d76564dex992.htm","title":"Zimmer Biomet Form 8-K exhibit (Monogram acquisition announcement; SEC)","sourceName":"SEC EDGAR"}],"aliases":["mBos","Monogram mBos","Monogram mBos TKA System","Monogram TKA"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"createdAt":"2026-06-04T15:09:52.265Z","updatedAt":"2026-06-04T15:09:52.265Z","jsonLd":{"@context":"https://schema.org","@type":"Product","@id":"https://registry.deploy.report/models/monogram-mbos","url":"https://registry.deploy.report/models/monogram-mbos","name":"mBos TKA System","alternateName":["mBos","Monogram mBos","Monogram mBos TKA System","Monogram TKA"],"description":"The Monogram mBos TKA System is Monogram's robotic total-knee-arthroplasty platform, recorded in the surgical form factor as the autonomy-boundary case of the orthopedic sub-cohort: unlike the AI-augmented surgeon-controlled systems Stryker Mako, Smith+Nephew CORI, and Zimmer Biomet ROSA, where the surgeon makes the cuts, the cleared mBos is semi-autonomous, with the robotic arm executing the bone cuts itself under AI control within a surgeon-approved, patient-specific CT-based plan and active surgeon supervision. It pairs CT-based pre-operative planning and predictive navigation with a robotic arm, built on a KUKA arm, that executes optimized cutting and insertion paths for Monogram's mPress press-fit implants. The system received FDA 510(k) clearance on March 17, 2025, although the precise cleared indication wording and the 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, which Monogram's own clearance release described 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 was performed on July 26, 2025 at Krishna Shalby Hospital in Ahmedabad, India under an India CDSCO approval for a 102-procedure investigation, not under US FDA, as a single index case without verified peer-reviewed outcomes. Made by Monogram Technologies, founded in 2015 as Monogram Orthopaedics by orthopedic surgeon Dr. Doug Unis, who is chief medical officer and founder rather than chief executive, with Benjamin Sexson as the pre-acquisition CEO, and renamed Monogram Technologies in May 2024 trading on NASDAQ as MGRM, the company was acquired by Zimmer Biomet with the deal closing October 7, 2025 at about 168 million dollars enterprise value plus contingent value rights, making Monogram a Zimmer Biomet subsidiary with commercialization alongside Zimmer Biomet implants targeted for early 2027. The registry records the system at research maturity because it is cleared but pre-commercial with no units sold, and its headline fully-autonomous capability remains in development.","identifier":"078e765e-b40f-43c4-a23e-50643a23484e","category":"surgical","publisher":{"@id":"https://deploy.report/#organization"}}}