Ellipse Technologies, Inc.: FDA clearances and approvals
Ellipse Technologies, Inc. has 13 FDA 510(k) clearances (first 2011, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time: 103 days. It is the industry lead sponsor of 4 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 228 |
| 2013 | 2 | 84 |
| 2014 | 6 | 68 |
| 2015 | 1 | 312 |
| 2016 | 1 | 59 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 10 | 10 |
| PGN | Growing Rod System- Magnetic Actuation | 3 | 3 |
Review panels
- Orthopedic (13)
Most recent Ellipse Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160325 | PRECICE Intramedullary Limb Lengthening System | HSB | 2016-04-04 | 59 |
| K141278 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | PGN | 2015-03-24 | 312 |
| K141739 | RESIDUAL LIMB LENGTHENING SYSTEM | HSB | 2014-10-07 | 102 |
| K140613 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | PGN | 2014-09-18 | 192 |
| K141447 | PRECICE TRAUMA NAIL SYSTEM | HSB | 2014-06-30 | 28 |
| K141023 | PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | HSB | 2014-05-20 | 29 |
| K140178 | ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | PGN | 2014-02-27 | 34 |
| K131490 | ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | HSB | 2014-01-23 | 245 |
| K133289 | PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | HSB | 2013-12-09 | 45 |
| K131677 | PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | HSB | 2013-10-11 | 123 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ellipse Technologies, Inc..
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
Ellipse Technologies, Inc. is the industry lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03431662: Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy (Completed, started 2016-03)
- NCT02519218: Ellipse Intramedullary High Tibial Osteotomy Nail Study (Completed, started 2015-08)
- NCT02412163: Ellipse Intramedullary Nail High Tibial Osteotomy Study (Completed, started 2015-07)
- NCT01362881: Study of the Surgical Treatment of Early Onset Scoliosis Using a Non-invasive Growing Rod (Completed, started 2012-01)
Frequently asked questions
How many FDA 510(k) clearances does Ellipse Technologies, Inc. have?
Ellipse Technologies, Inc. has 13 FDA 510(k) clearances (first 2011, latest 2016), across 2 product codes in 1 review panel.
How long does FDA take to clear Ellipse Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ellipse Technologies, Inc.'s cleared 510(k)s is 103 days.
What devices does Ellipse Technologies, Inc. make?
Its most frequent FDA product codes are HSB (Rod, Fixation, Intramedullary And Accessories, 10); PGN (Growing Rod System- Magnetic Actuation, 3).
Has Ellipse Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ellipse Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 13 Ellipse Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HSB, Ellipse Technologies, 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.