Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mako Surgical Corp. — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
192 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260222 | Mako Total Knee Application | Mako Surgical Corp. | 2026-02-25 | 30 | 0 |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | Mako Surgical Corp. | 2025-04-25 | 56 | 0 |
| K243751 | Mako Total Hip Application 5.0 | Mako Surgical Corp. | 2025-03-05 | 90 | 0 |
| K242373 | Mako Shoulder Application (1.0) | Mako Surgical Corp. | 2024-11-07 | 90 | 0 |
| K241011 | Mako Total Knee Application | Mako Surgical Corp. | 2024-06-11 | 60 | 1 |
| K220930 | Restoris Multi-Compartmental Knee System | Mako Surgical Corp. | 2022-06-02 | 63 | 0 |
| K220459 | Mako Total Knee Application | Mako Surgical Corp. | 2022-04-15 | 57 | 7 |
| K193515 | Mako Total Knee Application | Mako Surgical Corp. | 2020-07-14 | 208 | 6 |
| K193128 | Mako Total Hip Application | Mako Surgical Corp. | 2020-02-02 | 82 | 0 |
| K191998 | Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. | 2019-09-24 | 60 | 0 |
| K172301 | Mako Partial Knee Application | Mako Surgical Corp. | 2017-11-02 | 94 | 6 |
| K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017-09-21 | 59 | 0 |
| K170891 | Mako Partial Knee Application | Mako Surgical Corp. | 2017-05-24 | 58 | 0 |
| K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017-05-11 | 72 | 0 |
| K170584 | Mako Partial Knee Application | Mako Surgical Corp. | 2017-05-11 | 72 | 0 |
| K170593 | Mako Total Hip Application | Mako Surgical Corp. | 2017-04-18 | 49 | 0 |
| K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015-08-06 | 218 | 0 |
| K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015-03-10 | 29 | 0 |
| K142606 | Trident® Tritanium® PST® Acetabular Shells | Mako Surgical Corp. | 2015-01-26 | 133 | 0 |
| K133811 | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mako Surgical Corp. | 2014-07-08 | 204 | 0 |
| K093425 | MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM | Mako Surgical Corp. | 2010-02-24 | 113 | 2 |
| K091998 | ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP | Mako Surgical Corp. | 2009-09-28 | 88 | 0 |
| K083644 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP | Mako Surgical Corp. | 2009-06-19 | 192 | 0 |
| K081867 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 | Mako Surgical Corp. | 2008-11-25 | 147 | 2 |
| K082088 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II | Mako Surgical Corp. | 2008-10-22 | 90 | 0 |
| K082081 | MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM II | Mako Surgical Corp. | 2008-10-15 | 84 | 0 |
| K080368 | MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II | Mako Surgical Corp. | 2008-06-20 | 129 | 0 |
| K080029 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM | Mako Surgical Corp. | 2008-05-16 | 133 | 0 |
| K072806 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) | Mako Surgical Corp. | 2008-01-24 | 115 | 1 |
| K073248 | MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM | Mako Surgical Corp. | 2007-12-12 | 23 | 0 |
| K060017 | MAKO SURGICAL UNICONDYLAR KNEE SYSTEM | Mako Surgical Corp. | 2006-02-23 | 50 | 0 |
| K052851 | VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) | Mako Surgical Corp. | 2005-11-18 | 38 | 0 |
| K050973 | MODIFICATION TO: VOYAGER LINUX | Mako Surgical Corp. | 2005-05-17 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda