# Mako Surgical Corp.

- Location (FDA's records): Fort Lauderdale, FL
- FDA decisions: 42 (2005–2026): 42 510(k) clearances
- Names in FDA's records: Mako Surgical Corp. (33); Mako Surgical Corporation (8); Mako Surgical (1)
- Product codes: OLO (23), HSX (6), HAW (4), NPJ (3), KRR (2), HRY (1), LPH (1), NJD (1), JWH (1)
- 510(k) review time since 2016: median 60 days, against 91 for FDA's reviews in the same codes and years (12 of 15 faster)
- Predicates its devices cite: 96 (43 its own); citations of its devices by later devices: 65 (43 its own)
- Recalls linked to its devices: 39 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Brainlab AG: 13 (https://510kreport.com/company/brainlab)
- Howmedica Osteonics Corp.: 11 (https://510kreport.com/company/howmedica-osteonics)
- Biomet, Inc.: 5 (https://510kreport.com/company/biomet)
- Orthosoft, Inc.: 4 (https://510kreport.com/company/orthosoft)
- Encore Orthopedics, Inc.: 2 (https://510kreport.com/company/encore-orthopedics)
- Encore Medical L.P.: 2 (https://510kreport.com/company/encore-medical)
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- DePuy Orthopaedics, Inc.: 2 (https://510kreport.com/company/depuy-orthopaedics)

## Firms that cite its devices most
- Blue Belt Technologies, Inc.: 3 (https://510kreport.com/company/blue-belt-technologies)
- Biomet Manufacturing Corp: 2 (https://510kreport.com/company/biomet-manufacturing)
- Stryker Orthopaedics: 2 (https://510kreport.com/company/stryker-orthopaedics)
- Orthosoft Inc (D/B/A Zimmer Cas): 2 (https://510kreport.com/company/orthosoft-d-b-a-zimmer-cas)
- Hangzhou Lancet Robotics Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-lancet-robotics)
- Stryker Leibinger GmbH & Co KG: 1 (https://510kreport.com/company/stryker-leibinger)
- Ignite Orthomotion: 1 (https://510kreport.com/company/ignite-orthomotion)
- Nanoortho, LLC: 1 (https://510kreport.com/company/nanoortho)

## Its most-cited devices
- K133811: Restoris Porous Partial Knee System (2014), cited by 5
- K081867: Mako Surgical Tactile Guidance System Version 2.0 (2008), cited by 5
- K090763: Restoris Multicompartmental Knee (MCK) System (2009), cited by 4
- K143752: Total Knee Application (TKA) (2015), cited by 3
- K052851: Voyager Linux with Tactile Guidance System (TGS) (2005), cited by 3
- K112507: Restoris Partial Knee Application (Pka), Rio Standard System (2012), cited by 3

## Recent decisions
- K260222: Mako Total Knee Application (Feb 25, 2026)
- K250608: Mako Total Knee Application (3.0); Hybrid Tip Pointer (Apr 25, 2025)
- K243751: Mako Total Hip Application 5.0 (Mar 5, 2025)
- K242373: Mako Shoulder Application (1.0) (Nov 7, 2024)
- K241011: Mako Total Knee Application (Jun 11, 2024)
- K220930: Restoris Multi-Compartmental Knee System (Jun 2, 2022)
- K220459: Mako Total Knee Application (Apr 15, 2022)
- K193515: Mako Total Knee Application (Jul 14, 2020)

Source page: https://510kreport.com/company/mako-surgical