FDA product code OWI: Bone Fixation Cerclage, Sublaminar
OWI is the FDA product code for bone fixation cerclage, sublaminar. It is a Class II device, regulated under 21 CFR 888.3010 and reviewed by the Orthopedic panel. FDA has cleared 37 510(k) submissions under OWI, 5 in the last five years, from 20 different applicants. The average 510(k) review took 112 days (median 89); 78 days on average over the last three years. FDA has posted 2 recalls for OWI devices.
Definition
Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
Classification
| Field | Value |
|---|---|
| Device name | Bone Fixation Cerclage, Sublaminar |
| Device class | Class II |
| Regulation | 21 CFR 888.3010 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OWI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 122 |
| 2018 | 4 | 157 |
| 2019 | 3 | 56 |
| 2020 | 3 | 68 |
| 2021 | 1 | 48 |
| 2022 | 1 | 186 |
| 2023 | 2 | 170 |
| 2026 | 2 | 78 |
Compare with all 510(k) review times · Search every OWI clearance
Top OWI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Implanet, S.A. | 7 | 2019-08-02 |
| Medicrea International SA | 4 | 2022-05-24 |
| Globus Medical, Inc. | 3 | 2023-04-20 |
| K2m, Inc. | 3 | 2017-04-05 |
| OrthoPediatrics Corp. | 2 | 2020-03-16 |
15 more applicants have OWI clearances. See the full list in Caduvo.
Most recent OWI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261374 | Medicrea International S.A.S | LigaPASS System | 2026-05-27 | 30 |
| K253615 | Alphatec Spine, Inc. | Invictus Bands System | 2026-03-25 | 127 |
| K222097 | Astura Medical | OLYMPIC Deformity Band System | 2023-05-04 | 290 |
| K230565 | Globus Medical, Inc. | HILINE Fixation System | 2023-04-20 | 50 |
| K213659 | Medicrea International SA | LigaPASS 2.0 Ligament Augmentation System | 2022-05-24 | 186 |
Recalls for OWI devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-10-08.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code OWI?
OWI is the FDA product code for bone fixation cerclage, sublaminar. It is a Class II device, regulated under 21 CFR 888.3010 and reviewed by the Orthopedic panel.
What device class is OWI?
Class II, regulation 21 CFR 888.3010. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWI?
Across 37 cleared submissions the average was 112 days from receipt to decision (median 89).
Which companies have the most OWI clearances?
Implanet, S.A. (7); Medicrea International SA (4); Globus Medical, Inc. (3); K2m, Inc. (3); OrthoPediatrics Corp. (2).
Have OWI devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2020-10-08.
Next steps
- Run an FDA pathway report with predicate devices for product code OWI
- Run a recall and safety report across every OWI manufacturer
- Watch product code OWI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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