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510(k) K252949

Geminus Volar Distal Radius Plating System by Skeletal Dynamics, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2025
Date Received
September 16, 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

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  • K240835 — Suture Button Repair System (July 19, 2024)
  • K233574 — Total Wrist Arthroplasty System (TWA) (July 3, 2024)
  • K231447 — Double Internal Joint Stabilizer- Elbow (December 15, 2023)
  • K231188 — ALIGN Radial Head System (September 28, 2023)
  • K231623 — Distal Elbow Plating System (August 28, 2023)
  • K223318 — Internal Joint Stabilizer - Elbow (May 10, 2023)

Other clearances for product code HRS

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  • 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)