510(k) · Cleared
ClearedmBôs (Monogram mBôs TKA System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monogram Orthopaedics, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Mar 14, 2025 as substantially equivalent to K143752 (Mako Surgical Corp., 2015) after a 238-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Mar 14, 2025
- Review
- 238 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K905070 (1991). 40 ancestors in all, the oldest K861692 (1986). No later device cites it as a predicate yet.
- Root · 11 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 7 generations between
- 3 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 2 generations backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 1 generation backK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- This deviceK242121 mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 10 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 9 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 8 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 7 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 6 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 5 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 4 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 3 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 2 generations backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 1 generation backK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- This deviceK242121 mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −10 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −9 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −8 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −7 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −6 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −5 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −4 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −3 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −2 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| −1 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| 0 (this device) | K242121 | mBôs (Monogram mBôs TKA System) | Monogram Orthopaedics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K143752 | Total Knee Application (TKA)Summary page 5…s.com Phone: +1 (512) 790-5151 Prepared by: Nisha Patel Date Prepared: February 24, 2025 Classifications: Orthopedics Class: I Product Codes: oLo Primary Predicate: K143752 Product Name: mBOs TKA System INDICATIONS FOR USE The mBo6s TKA system is indicated for use in surgical knee procedures on adu… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 10 of the 40 ancestors have a recall of any class.
- 2 other devices also cite its predicate K143752.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The mBés TKA system is indicated for use in surgical knee procedures on adults in which the stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy.
These procedures include:
Total Knee Arthroplasty (TKA)
The implant systems compatible with the system:
mPress™ Total Knee System:
mPress™ TL: Cementless
mPress™ TC: Cemented
Each Implant System includes the Cruciate Retaining (CR), Cruciate Substituting (CS), and Posterior Stabilized (PS) implant types.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242121 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242121: mBôs (Monogram mBôs TKA System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242121
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026