K191399 is an FDA 510(k) clearance for the BIOLOX CONTOURA Ceramic Femoral Head. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II - Special Controls, product code LZO).
Submitted by Total Joint Othopedics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 28, 2019, 96 days after receiving the submission on May 24, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K191399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2019 |
| Decision Date | August 28, 2019 |
| Days to Decision | 96 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LZO - Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |