KLS Martin Pure Pectus System— 510(k) K221938

Name: FDA 510(k) clearance K221938
Creator: U.S. Food and Drug Administration
Published: 2023-03-28

Substantially Equivalent

KLS Martin L.P.

FDA 510(k) clearance K221938 for KLS Martin Pure Pectus System, Substantially Equivalent on 2023-03-28. Applicant: KLS Martin L.P.. Device class: 2.

Clearance details

Applicant: KLS Martin L.P.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2022-07-01
Decision date: 2023-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

More clearances from KLS Martin L.P.

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K260137 — KLS Martin IPS Oral-Max Implants - MR Conditional +3 more2026-08-17
K253660 — KLS Martin Pure Pectus System2026-02-20
K254162 — KLS Martin Ixos System2026-02-20
K250988 — KLS Martin Pure Pectus System2025-12-11
K250865 — KLS Martin IPS Forearm System2025-11-14

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.