Spinal Simplicity, LLC: FDA clearances and approvals
Spinal Simplicity, LLC has 16 FDA 510(k) clearances (first 2015, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time: 144 days. Since 2017 its median was 144 days, against 76 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 2 | 210 |
| 2016 | 0 | — |
| 2017 | 1 | 58 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 332 |
| 2021 | 1 | 105 |
| 2022 | 2 | 199 |
| 2023 | 3 | 158 |
| 2024 | 3 | 84 |
| 2025 | 2 | 108 |
| 2026 | 1 | 154 |
Review time against the same product codes
Since 2017, Spinal Simplicity, LLC's cleared 510(k)s took a median 144 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 76 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PEK | Spinous Process Plate | 10 | 10 |
| OUR | Sacroiliac Joint Fixation | 3 | 3 |
| HRX | Arthroscope | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
Review panels
- Orthopedic (16)
Most recent Spinal Simplicity, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253523 | Freedom DS Decompression System | HRX | 2026-04-16 | 154 |
| K253250 | Minuteman® G6 MIS Fusion Plate | PEK | 2025-12-01 | 63 |
| K250001 | Patriot SI Implant System | OUR | 2025-06-03 | 152 |
| K240592 | Wolff's Law Anterior Cervical Plate System | KWQ | 2024-05-24 | 84 |
| K232259 | Patriot-SI Posterior Implant System | OUR | 2024-04-19 | 263 |
| K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 | PEK | 2024-01-18 | 28 |
| K231923 | Liberty SI Lateral Implant System | OUR | 2023-12-05 | 158 |
| K233527 | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate | PEK | 2023-11-29 | 28 |
| K221307 | Edge Upper Cervical System | NKG | 2023-07-10 | 431 |
| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 | PEK | 2022-08-19 | 135 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Spinal Simplicity, LLC.
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
Spinal Simplicity, LLC is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07204288: Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices (Recruiting, started 2025-09-11)
- NCT06355791: Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device (Recruiting, started 2024-05-29)
- NCT01455805: Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis (Completed, started 2012-06)
Frequently asked questions
How many FDA 510(k) clearances does Spinal Simplicity, LLC have?
Spinal Simplicity, LLC has 16 FDA 510(k) clearances (first 2015, latest 2026), across 5 product codes in 1 review panel.
How long does FDA take to clear Spinal Simplicity, LLC's 510(k)s?
The median time from FDA receipt to decision across Spinal Simplicity, LLC's cleared 510(k)s is 144 days. Since 2017: 144 days, versus 76 days for all cleared 510(k)s in the same product codes.
What devices does Spinal Simplicity, LLC make?
Its most frequent FDA product codes are PEK (Spinous Process Plate, 10); OUR (Sacroiliac Joint Fixation, 3); HRX (Arthroscope, 1).
Has Spinal Simplicity, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Spinal Simplicity, LLC. Related entities may recall under other names.
Next steps
- See all 16 Spinal Simplicity, LLC clearances with predicates and recalls
- Run predicate analysis for product code PEK, Spinal Simplicity, LLC'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.