KLS Martin Pure Pectus System— 510(k) K253660
Substantially EquivalentKLS-Martin L.P.
FDA 510(k) clearance K253660 for KLS Martin Pure Pectus System, Substantially Equivalent on 2026-02-20. Applicant: KLS-Martin L.P.. Device class: 2.
Summary
KLS-Martin's KLS Martin Pure Pectus System is filed under product code HRS, bone fixation plate. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
KLS-Martin filed from Jacksonville, Florida. The decision came 92 calendar days after FDA received it (November 20, 2025 to February 20, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- KLS-Martin L.P.
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
Recent devices under product code HRS
view allMore clearances from KLS-Martin L.P.
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.