Paradigm Spine: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Paradigm Spine” (first 2008, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 87 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 87 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Paradigm Spine took a median 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (3)
Most recent Paradigm Spine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213493 | Fortilink with TiPlus Technology | ODP | 2022-01-27 | 87 |
| K071668 | ORTHOBIOM SPINAL SYSTEM | MNI | 2008-07-02 | 379 |
| K080963 | DSS STABILIZATION SYSTEM | NQP | 2008-05-02 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Paradigm Spine.
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.
Device clinical trials
An industry sponsor named Paradigm Spine is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03041896: Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion (Completed, started 2016-07)
- NCT02918669: Study to Investigate the Long Term Survivorship of Coflex (Completed, started 2016-04)
- NCT00534235: Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis (Completed, started 2012-10)
- NCT01316211: Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis (Completed, started 2008-01)
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.
- Paradigm Spine, LLC (11 510(k)s)
- Paradigm Medical Industries, Inc. (10 510(k)s)
- Paradigm Medical, Inc. (3 510(k)s)
- Paradigm Spine GmbH (2 510(k)s)
- Paradigm Lasers, Inc. (1 510(k)s)
- Paradigm Trex, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Paradigm Spine?
FDA lists 3 510(k) clearances under the applicant name “Paradigm Spine” (first 2008, latest 2022), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Paradigm Spine?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paradigm Spine is 87 days.
Which FDA product codes appear under Paradigm Spine?
The most frequent FDA product codes under this applicant name are MNI (Orthosis, Spinal Pedicle Fixation, 1); NQP (Posterior Metal/Polymer Spinal System, Fusion, 1); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 1).
Next steps
- See all 3 Paradigm Spine clearances with predicates and recalls
- Run predicate analysis for product code MNI, Paradigm Spine'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.