510(k) K252846
K252846 is an FDA 510(k) premarket notification submitted by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics for the device "TaperSet Hip System". The FDA issued a decision of Substantially Equivalent on November 20, 2025. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2025
- Date Received
- September 8, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3358
- Review Panel
- OR
- Submission Type