Submission Details
| 510(k) Number | K250988 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 31, 2025 |
| Decision Date | December 11, 2025 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
KLS Martin Pure Pectus System
Dec 2025
Decision
255d
Days
Class 2
Risk
About This 510(k) Submission
K250988 is an FDA 510(k) clearance for the KLS Martin Pure Pectus System, 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 December 11, 2025, 255 days after receiving the submission on March 31, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.
Device Classification
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
Manufacturer
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