K253660 is an FDA 510(k) clearance for the KLS Martin Pure Pectus System. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on February 20, 2026, 92 days after receiving the submission on November 20, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K253660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2025 |
| Decision Date | February 20, 2026 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |