K212414 is an FDA 510(k) clearance for the OSSDSIGN Cranial PSI. This device is classified as a Filler, Bone Void, Non-alterable Compound For Cranioplasty (Class II - Special Controls, product code PJN).
Submitted by Ossdsign AB (Uppsala, SE). The FDA issued a Cleared decision on October 1, 2021, 59 days after receiving the submission on August 3, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5330. A Nonalterable Cranial Bone Void Filler Is A Device That Is Created From Patient-specific Computerized Tomography (ct) Imaging Data And Intended To Fill Bony Voids, Defects, And Contour Irregularities In Non-load Bearing Regions Of The Cranial Skeleton, And Are Not Intrinsic To The Stability Of The Bony Structure. The Materials Used (e.g., Metals, Polyether Ether Ketone (peek), Etc.) In The Construction Of The Nonalterable Cranial Bone Void Fillers Are Not Resorbable And Cannot Be Altered Or Reshaped At The Time Of Surgery Or After Implantation Without Changing The Chemical Behavior Of The Material..
| 510(k) Number | K212414 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2021 |
| Decision Date | October 01, 2021 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PJN — Filler, Bone Void, Non-alterable Compound For Cranioplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5330 |
| Definition | A Nonalterable Cranial Bone Void Filler Is A Device That Is Created From Patient-specific Computerized Tomography (ct) Imaging Data And Intended To Fill Bony Voids, Defects, And Contour Irregularities In Non-load Bearing Regions Of The Cranial Skeleton, And Are Not Intrinsic To The Stability Of The Bony Structure. The Materials Used (e.g., Metals, Polyether Ether Ketone (peek), Etc.) In The Construction Of The Nonalterable Cranial Bone Void Fillers Are Not Resorbable And Cannot Be Altered Or Reshaped At The Time Of Surgery Or After Implantation Without Changing The Chemical Behavior Of The Material. |