Mako Surgical Corp.: FDA clearances and approvals
Mako Surgical Corp. has 42 FDA 510(k) clearances (first 2005, latest 2026), across 9 product codes in 2 review panels. Median 510(k) review time: 83 days. Since 2017 its median was 62 days, against 93 days for all cleared 510(k)s in the same product codes. openFDA lists 31 product recalls by a recalling firm named Mako Surgical Corp. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 122 |
| 2013 | 1 | 75 |
| 2014 | 2 | 159 |
| 2015 | 6 | 96 |
| 2016 | 0 | — |
| 2017 | 6 | 66 |
| 2018 | 0 | — |
| 2019 | 1 | 60 |
| 2020 | 2 | 145 |
| 2021 | 0 | — |
| 2022 | 2 | 60 |
| 2023 | 0 | — |
| 2024 | 2 | 75 |
| 2025 | 2 | 73 |
| 2026 | 1 | 30 |
Review time against the same product codes
Since 2017, Mako Surgical Corp.'s cleared 510(k)s took a median 62 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 23 | 23 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 6 | 6 |
| HAW | Neurological Stereotaxic Instrument | 4 | 4 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 | 3 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 2 | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
| NJD | Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer | 1 | 1 |
Review panels
- Orthopedic (38)
- Neurology (4)
Most recent Mako Surgical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260222 | Mako Total Knee Application | OLO | 2026-02-25 | 30 |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | OLO | 2025-04-25 | 56 |
| K243751 | Mako Total Hip Application 5.0 | OLO | 2025-03-05 | 90 |
| K242373 | Mako Shoulder Application (1.0) | OLO | 2024-11-07 | 90 |
| K241011 | Mako Total Knee Application | OLO | 2024-06-11 | 60 |
| K220930 | Restoris Multi-Compartmental Knee System | HSX | 2022-06-02 | 63 |
| K220459 | Mako Total Knee Application | OLO | 2022-04-15 | 57 |
| K193515 | Mako Total Knee Application | OLO | 2020-07-14 | 208 |
| K193128 | Mako Total Hip Application | OLO | 2020-02-02 | 82 |
| K191998 | Mako Total Hip Application, Mako Total Knee Application | OLO | 2019-09-24 | 60 |
32 earlier clearances. See the full list in Caduvo.
Recalls
31 product recalls in 26 recall events; 1 initiated in the last five years. Most recent: 2022-08-08.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Mako Surgical Corp. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02058069: Robotic Arm Assisted Total Knee Arthroplasty (Completed, started 2014-02)
Frequently asked questions
How many FDA 510(k) clearances does Mako Surgical Corp. have?
Mako Surgical Corp. has 42 FDA 510(k) clearances (first 2005, latest 2026), across 9 product codes in 2 review panels.
How long does FDA take to clear Mako Surgical Corp.'s 510(k)s?
The median time from FDA receipt to decision across Mako Surgical Corp.'s cleared 510(k)s is 83 days. Since 2017: 62 days, versus 93 days for all cleared 510(k)s in the same product codes.
What devices does Mako Surgical Corp. make?
Its most frequent FDA product codes are OLO (Orthopedic Stereotaxic Instrument, 23); HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, 6); HAW (Neurological Stereotaxic Instrument, 4).
Has Mako Surgical Corp. had device recalls?
openFDA lists 31 product recalls in 26 recall events by a recalling firm whose name matches Mako Surgical Corp; the most recent began 2022-08-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 42 Mako Surgical Corp. clearances with predicates and recalls
- Run predicate analysis for product code OLO, Mako Surgical Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.