Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
The Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer + Additive is a total hip prosthesis component intended for primary and revision patients at high risk of dislocation due to prior dislocation history, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom other options have been considered. It falls under the Orthopedic medical specialty and is classified as a Class 2 device under regulation 888.3310, requiring 510(k) premarket notification. As an implanted device, it is subject to general controls and special controls; it is not considered life-sustaining.
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Basic Information
- Product Code
- PBI
- Device Class
- FDA class 2
- Regulation Number
- 888.3310
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.