FDA product code OIS: Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
OIS is the FDA product code for calcium salt bone void filler, drillable, non-screw augmentation. It is a Class II device, regulated under 21 CFR 888.3045 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under OIS. The average 510(k) review took 222 days (median 222). 1 PMA application cites this product code. FDA has posted 1 recall for OIS devices.
Definition
To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation.
Classification
| Field | Value |
|---|---|
| Device name | Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation |
| Device class | Class II |
| Regulation | 21 CFR 888.3045 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every OIS clearance
Top OIS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synthes (Usa) | 1 | 2008-07-02 |
Most recent OIS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K073303 | Synthes (Usa) | NORIAN DRILLABLE | 2008-07-02 | 222 |
Recalls for OIS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-08-10.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code OIS?
OIS is the FDA product code for calcium salt bone void filler, drillable, non-screw augmentation. It is a Class II device, regulated under 21 CFR 888.3045 and reviewed by the Orthopedic panel.
What device class is OIS?
Class II, regulation 21 CFR 888.3045. Typical premarket route: 510(k).
How long does a 510(k) take for product code OIS?
Across 1 cleared submissions the average was 222 days from receipt to decision (median 222).
Which companies have the most OIS clearances?
Synthes (Usa) (1).
Have OIS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code OIS
- Run a recall and safety report across every OIS manufacturer
- Watch product code OIS 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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