FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Trident® Tritanium® PST® Acetabular Shells
K Number: K142606
·
Decision Jan 26, 2015
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
33
Review Days
133
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Trident® Tritanium® PST® Acetabular Shells
- K Number
- K142606
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mako Surgical Corp.
- Date Received
- September 15, 2014
- Decision Date
- January 26, 2015
- Product Code
- LPH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPH), ordered by most recent decision date.
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
FDA 510(k)
FDA Class 2
·Orthopedic
Taperloc® Complete Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
G7® Revision Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
Mpact 3D Metal Implants Extension DMLS Technology
FDA 510(k)
FDA Class 2
·Orthopedic
Velora Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
TaperSet Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Mako Surgical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K260222 | Mako Total Knee Application | Feb 25, 2026 | Substantially Equivalent |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | Apr 25, 2025 | Substantially Equivalent |
| K243751 | Mako Total Hip Application 5.0 | Mar 5, 2025 | Substantially Equivalent |
| K242373 | Mako Shoulder Application (1.0) | Nov 7, 2024 | Substantially Equivalent |
| K241011 | Mako Total Knee Application | Jun 11, 2024 | Substantially Equivalent |
| K220930 | Restoris Multi-Compartmental Knee System | Jun 2, 2022 | Substantially Equivalent |
| K220459 | Mako Total Knee Application | Apr 15, 2022 | Substantially Equivalent |
| K193515 | Mako Total Knee Application | Jul 14, 2020 | Substantially Equivalent |
| K193128 | Mako Total Hip Application | Feb 2, 2020 | Substantially Equivalent |
| K191998 | Mako Total Hip Application, Mako Total Knee Application | Sep 24, 2019 | Substantially Equivalent |