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510(k) K253660

KLS Martin Pure Pectus System by KLS-Martin L.P. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2026
Date Received
November 20, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by KLS-Martin L.P.

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  • K233721 — KLS Martin Drill-Free MMF Screw (September 17, 2024)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (August 16, 2024)
  • K241018 — KLS Martin Orthopedic Implants - MR Conditional (July 12, 2024)
  • K230211 — CranioXpand (November 21, 2023)
  • K222624 — KLS Martin LINOS Wrist System (May 25, 2023)
  • K222397 — KLS Martin Level One Rib Fixation System (March 29, 2023)
  • K210731 — KLS Martin Individual Patient Solutions (July 18, 2022)

Other clearances for product code HRS

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  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)
  • K252807 — Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates (January 12, 2026)