FDA product code PAO: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
PAO is the FDA product code for prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented. It is a Class II device, regulated under 21 CFR 888.3660 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under PAO. The average 510(k) review took 116 days (median 116). FDA has posted 3 recalls for PAO devices, 1 initiated in the last five years.
Definition
Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3660 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PAO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 116 |
Compare with all 510(k) review times · Search every PAO clearance
Top PAO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tornier, Inc. | 1 | 2020-09-11 |
Most recent PAO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201315 | Tornier, Inc. | PERFORM Humeral System Stem | 2020-09-11 | 116 |
Recalls for PAO devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-08-29.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code PAO?
PAO is the FDA product code for prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented. It is a Class II device, regulated under 21 CFR 888.3660 and reviewed by the Orthopedic panel.
What device class is PAO?
Class II, regulation 21 CFR 888.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code PAO?
Across 1 cleared submissions the average was 116 days from receipt to decision (median 116).
Which companies have the most PAO clearances?
Tornier, Inc. (1).
Have PAO devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2024-08-29.
Next steps
- Run an FDA pathway report with predicate devices for product code PAO
- Run a recall and safety report across every PAO manufacturer
- Watch product code PAO 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