Medtronic Powered Surgical Solutions: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Medtronic Powered Surgical Solutions” (first 2007, latest 2021), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 99 days. Since 2017 the median was 116 days, against 94 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 72 |
| 2017 | 3 | 103 |
| 2018 | 0 | — |
| 2019 | 2 | 146 |
| 2020 | 0 | — |
| 2021 | 1 | 28 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medtronic Powered Surgical Solutions took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HBC | Motor, Drill, Electric | 3 | 3 |
| HBB | Motor, Drill, Pneumatic | 2 | 2 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 2 | 2 |
| OLO | Orthopedic Stereotaxic Instrument | 2 | 2 |
Review panels
- Neurology (7)
- Orthopedic (2)
Most recent Medtronic Powered Surgical Solutions 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm | HBE | 2021-11-23 | 28 |
| K183644 | Stealth-Midas MR8 System | OLO | 2019-05-22 | 147 |
| K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | HBC | 2019-05-12 | 145 |
| K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools | HBC | 2017-05-15 | 103 |
| K163565 | MR8 Drill System | HBC | 2017-03-28 | 99 |
| K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories | HBB | 2017-03-23 | 129 |
| K160713 | Stealth-Midas System | OLO | 2016-05-26 | 72 |
| K090112 | MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 | HBB | 2009-03-26 | 69 |
| K072315 | MIDAS REX CURVED BUR | HBE | 2007-09-18 | 29 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2008-05-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medtronic Vascular (480 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s)
- Medtronic, Inc. (247 510(k)s)
- Medtronic Sofamor Danek USA, Inc. (182 510(k)s)
- Medtronic Minimed (57 510(k)s)
- Medtronic Xomed, Inc. (47 510(k)s)
- Medtronic Navigation, Inc. (44 510(k)s)
- Medtronic Perfusion Systems (29 510(k)s)
- Medtronic Neurosurgery (27 510(k)s)
- Medtronic Blood Systems, Inc. (15 510(k)s)
- Medtronic PS Medical (14 510(k)s)
- Medtronic Ave, Inc. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic Powered Surgical Solutions?
FDA lists 9 510(k) clearances under the applicant name “Medtronic Powered Surgical Solutions” (first 2007, latest 2021), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medtronic Powered Surgical Solutions?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Powered Surgical Solutions is 99 days. Since 2017: 116 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medtronic Powered Surgical Solutions?
The most frequent FDA product codes under this applicant name are HBC (Motor, Drill, Electric, 3); HBB (Motor, Drill, Pneumatic, 2); HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered), 2).
Next steps
- See all 9 Medtronic Powered Surgical Solutions clearances with predicates and recalls
- Run predicate analysis for product code HBC, Medtronic Powered Surgical Solutions's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.