FDA product code PBI: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
PBI is the FDA product code for prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive. It is a Class II device, regulated under 21 CFR 888.3310 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under PBI, 1 in the last five years, from 2 different applicants. The average 510(k) review took 205 days (median 205). FDA has posted 2 recalls for PBI devices.
Definition
For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive |
| Device class | Class II |
| Regulation | 21 CFR 888.3310 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PBI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 261 |
Compare with all 510(k) review times · Search every PBI clearance
Top PBI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zimmer, Inc. | 1 | 2022-04-28 |
| Biomet Manufacturing Corp | 1 | 2012-11-23 |
Most recent PBI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212512 | Zimmer, Inc. | G7® Vivacit-E® Freedom® Constrained Liner | 2022-04-28 | 261 |
| K121874 | Biomet Manufacturing Corp | G7 ACETABULAR SYSTEM | 2012-11-23 | 149 |
Recalls for PBI devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-05-07.
Frequently asked questions
What is FDA product code PBI?
PBI is the FDA product code for prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive. It is a Class II device, regulated under 21 CFR 888.3310 and reviewed by the Orthopedic panel.
What device class is PBI?
Class II, regulation 21 CFR 888.3310. Typical premarket route: 510(k).
How long does a 510(k) take for product code PBI?
Across 2 cleared submissions the average was 205 days from receipt to decision (median 205).
Which companies have the most PBI clearances?
Zimmer, Inc. (1); Biomet Manufacturing Corp (1).
Have PBI devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2014-05-07.
Next steps
- Run an FDA pathway report with predicate devices for product code PBI
- Run a recall and safety report across every PBI manufacturer
- Watch product code PBI 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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