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510(k) K260069

DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System by Synthes GmbH — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2026
Date Received
January 9, 2026
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 Synthes GmbH

  • K254093 — DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System (March 10, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K243715 — Synthes Patient Specific Implants (November 12, 2025)
  • K241927 — Synthes Graphic Case & Tray System (March 28, 2025)
  • K233994 — VOLT™ Proximal Humerus 3.5 Plating System (July 26, 2024)
  • K233967 — DePuy Synthes MatrixSTERNUM Fixation System (May 9, 2024)
  • K131792 — SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY (December 16, 2013)
  • K123723 — SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM (September 5, 2013)
  • K122455 — SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM (April 11, 2013)
  • K122647 — SYNTHES PATIENT SPECIFIC PLATE (February 28, 2013)

Other clearances for product code HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • 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)
  • K253660 — KLS Martin Pure Pectus System (February 20, 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)