FDA product code OAR: Injector, Vertebroplasty (Does Not Contain Cement)
OAR is the FDA product code for injector, vertebroplasty (does not contain cement). It is a Class I device, regulated under 21 CFR 888.4200 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under OAR. The average 510(k) review took 63 days (median 63). FDA has posted 26 recalls for OAR devices, 2 initiated in the last five years.
Definition
Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Classification
| Field | Value |
|---|---|
| Device name | Injector, Vertebroplasty (Does Not Contain Cement) |
| Device class | Class I |
| Regulation | 21 CFR 888.4200 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OAR clearance
Top OAR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrocare Corp. | 1 | 2005-09-06 |
Most recent OAR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051820 | Arthrocare Corp. | PARALLAX EZFLOW CEMENT DELIVERY SYSTEM | 2005-09-06 | 63 |
Recalls for OAR devices
26 product recalls in 9 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-08-19.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2020 | 2 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code OAR?
OAR is the FDA product code for injector, vertebroplasty (does not contain cement). It is a Class I device, regulated under 21 CFR 888.4200 and reviewed by the Orthopedic panel.
What device class is OAR?
Class I, regulation 21 CFR 888.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OAR?
Across 1 cleared submissions the average was 63 days from receipt to decision (median 63).
Which companies have the most OAR clearances?
Arthrocare Corp. (1).
Have OAR devices been recalled?
Yes: 26 product recalls across 9 recall events; the most recent began 2024-08-19.
Next steps
- Run an FDA pathway report with predicate devices for product code OAR
- Run a recall and safety report across every OAR manufacturer
- Watch product code OAR 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times