Medtronic Sofamor Danek: FDA clearances and approvals
Medtronic Sofamor Danek has 253 FDA 510(k) clearances (first 2000, latest 2025), plus 2 PMA decisions, across 30 product codes in 4 review panels. Median 510(k) review time: 61 days. Since 2017 its median was 74 days, against 94 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 9 | 67 |
| 2013 | 8 | 88 |
| 2014 | 4 | 49 |
| 2015 | 0 | — |
| 2016 | 2 | 82 |
| 2017 | 5 | 66 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 106 |
| 2021 | 1 | 131 |
| 2022 | 0 | — |
| 2023 | 1 | 125 |
| 2024 | 0 | — |
| 2025 | 2 | 52 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Medtronic Sofamor Danek's cleared 510(k)s took a median 74 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 50 | 50 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 44 | 44 |
| MQP | Spinal Vertebral Body Replacement Device | 30 | 30 |
| MNI | Orthosis, Spinal Pedicle Fixation | 23 | 23 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 20 | 20 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 18 | 18 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 17 | 17 |
| MQV | Filler, Bone Void, Calcium Compound | 11 | 11 |
| JDK | Prosthesis, Hip, Cement Restrictor | 5 | 5 |
| HRX | Arthroscope | 3 | 3 |
Plus 20 more product codes.
Review panels
- Orthopedic (247)
- Dental (5)
- General and Plastic Surgery (2)
- Neurology (1)
Most recent Medtronic Sofamor Danek 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251193 | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft | MQV | 2025-06-12 | 56 |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | MQV | 2025-01-17 | 49 |
| K230716 | Robotic Graft Delivery Instruments | OLO | 2023-07-18 | 125 |
| K212428 | Centerpiece Plate Fixation System | NQW | 2021-12-13 | 131 |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | MAX | 2020-08-26 | 106 |
| K173125 | T2 STRATOSPHERE Expandable Corpectomy System | MQP | 2017-12-20 | 82 |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium | MAX | 2017-09-19 | 60 |
| K171031 | CRESCENT Spinal System | MAX | 2017-07-06 | 91 |
| K171468 | FUSE Spinal System | MAX | 2017-06-13 | 26 |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems | NKB | 2017-05-11 | 66 |
243 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P060018 | PMA | PRESTIGE CERVICAL DISC SYSTEM | 2007-07-16 |
| P040001 | PMA | X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM | 2005-11-21 |
Recalls
openFDA lists no recalls under a recalling firm named Medtronic Sofamor Danek.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Medtronic Sofamor Danek's product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Medtronic Sofamor Danek have?
Medtronic Sofamor Danek has 253 FDA 510(k) clearances (first 2000, latest 2025), plus 2 PMA decisions, across 30 product codes in 4 review panels.
How long does FDA take to clear Medtronic Sofamor Danek's 510(k)s?
The median time from FDA receipt to decision across Medtronic Sofamor Danek's cleared 510(k)s is 61 days. Since 2017: 74 days, versus 94 days for all cleared 510(k)s in the same product codes.
What devices does Medtronic Sofamor Danek make?
Its most frequent FDA product codes are NKB (Thoracolumbosacral Pedicle Screw System, 50); KWP (Appliance, Fixation, Spinal Interlaminal, 44); MQP (Spinal Vertebral Body Replacement Device, 30).
Has Medtronic Sofamor Danek had device recalls?
openFDA lists no recalls under a recalling firm name matching Medtronic Sofamor Danek. Related entities may recall under other names.
Next steps
- See all 253 Medtronic Sofamor Danek clearances with predicates and recalls
- Run predicate analysis for product code NKB, Medtronic Sofamor Danek'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.