Medtronic Sofamor Danek USA, Inc.: FDA clearances and approvals
Medtronic Sofamor Danek USA, Inc. has 182 FDA 510(k) clearances (first 2000, latest 2026), plus 4 PMA decisions, across 32 product codes in 6 review panels. Median 510(k) review time: 84 days. Since 2017 its median was 88 days, against 104 days for all cleared 510(k)s in the same product codes. openFDA lists 172 product recalls by a recalling firm named Medtronic Sofamor Danek USA, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 7 | 56 |
| 2013 | 18 | 87 |
| 2014 | 16 | 82 |
| 2015 | 19 | 87 |
| 2016 | 10 | 68 |
| 2017 | 9 | 120 |
| 2018 | 9 | 63 |
| 2019 | 12 | 120 |
| 2020 | 6 | 89 |
| 2021 | 7 | 30 |
| 2022 | 6 | 63 |
| 2023 | 4 | 30 |
| 2024 | 4 | 96 |
| 2025 | 5 | 48 |
| 2026 | 6 | 98 |
Review time against the same product codes
Since 2017, Medtronic Sofamor Danek USA, Inc.'s cleared 510(k)s took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 48 | 48 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 38 | 37 |
| OLO | Orthopedic Stereotaxic Instrument | 15 | 15 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 10 | 10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 9 | 9 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 8 | 8 |
| NKG | Posterior Cervical Screw System | 7 | 7 |
| MQP | Spinal Vertebral Body Replacement Device | 6 | 6 |
| MQV | Filler, Bone Void, Calcium Compound | 5 | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
Plus 22 more product codes.
Review panels
- Orthopedic (170)
- Dental (6)
- General Hospital (4)
- General and Plastic Surgery (3)
- Neurology (2)
- Radiology (1)
Most recent Medtronic Sofamor Danek USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253011 | Catalyft PL Expandable Interbody System | MAX | 2026-07-17 | 301 |
| K261020 | Symmetrix L Spinal System | MAX | 2026-07-14 | 109 |
| K253656 | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System | GEI | 2026-06-05 | 197 |
| K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | NKB | 2026-04-21 | 88 |
| K254165 | Infinity OCT System | NKG | 2026-01-21 | 30 |
| K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) | NKB | 2026-01-07 | 29 |
| K253335 | CD Horizon Spinal System | NKB | 2025-10-24 | 24 |
| K253129 | Infinity OCT System | NKG | 2025-10-24 | 29 |
| K251444 | Endoskeleton Interbody Systems | MAX | 2025-09-04 | 118 |
| K251395 | The Rialto SI Fusion System | OUR | 2025-06-26 | 52 |
172 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P090029 | PMA | PRESTIGE LP CERVICAL DISC | 2014-07-24 |
| P000054 | PMA | INFUSE BONE GRAFT | 2004-04-30 |
| P000058 | PMA | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE | 2002-07-02 |
| P000028 | PMA | AFFINITY (TM) CAGE SYSTEM | 2002-06-13 |
Recalls
172 product recalls in 45 recall events; 35 initiated in the last five years. Most recent: 2025-09-16.
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.
Frequently asked questions
How many FDA 510(k) clearances does Medtronic Sofamor Danek USA, Inc. have?
Medtronic Sofamor Danek USA, Inc. has 182 FDA 510(k) clearances (first 2000, latest 2026), plus 4 PMA decisions, across 32 product codes in 6 review panels.
How long does FDA take to clear Medtronic Sofamor Danek USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medtronic Sofamor Danek USA, Inc.'s cleared 510(k)s is 84 days. Since 2017: 88 days, versus 104 days for all cleared 510(k)s in the same product codes.
What devices does Medtronic Sofamor Danek USA, Inc. make?
Its most frequent FDA product codes are NKB (Thoracolumbosacral Pedicle Screw System, 48); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 38); OLO (Orthopedic Stereotaxic Instrument, 15).
Has Medtronic Sofamor Danek USA, Inc. had device recalls?
openFDA lists 172 product recalls in 45 recall events by a recalling firm whose name matches Medtronic Sofamor Danek USA, Inc; the most recent began 2025-09-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 182 Medtronic Sofamor Danek USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Medtronic Sofamor Danek USA, Inc.'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.