FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOLOX CONTOURA Ceramic Femoral Head
K Number: K191399
·
Decision Aug 28, 2019
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
8
Review Days
96
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
- BIOLOX CONTOURA Ceramic Femoral Head
- K Number
- K191399
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Total Joint Othopedics, Inc.
- Date Received
- May 24, 2019
- Decision Date
- August 28, 2019
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZO), ordered by most recent decision date.
Z1 Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
Avenir® Müller Stem; Avenir Complete Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
implantcast Packaging System Update
FDA 510(k)
FDA Class 2
·Orthopedic
implaFit® short stems
FDA 510(k)
FDA Class 2
·Orthopedic
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
FDA 510(k)
FDA Class 2
·Orthopedic
Coated hip implants
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Total Joint Othopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Mar 24, 2025 | Substantially Equivalent |
| K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post | Sep 8, 2023 | Substantially Equivalent |
| K230537 | Klassic Knee Revision System | May 19, 2023 | Substantially Equivalent |
| K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | Dec 3, 2021 | Substantially Equivalent |
| K171962 | Klassic HD® Hip System | Jul 24, 2017 | Substantially Equivalent |
| K161073 | Klassic HD Hip System | Oct 19, 2016 | Substantially Equivalent |
| K143407 | Klassic HD Hip System | Dec 23, 2014 | Substantially Equivalent |