Home / 510(k) Clearances / K111663

510(k) K111663

TRAUMA INTERNAL FIXATION SYSTEMS by DePuy Orthopaedics, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2012
Date Received
June 14, 2011
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 DePuy Orthopaedics, Inc.

  • K231503 — CUPTIMIZE™ Advanced (August 22, 2023)
  • K213839 — DePuy Corail AMT Hip Prosthesis (January 6, 2022)
  • K210167 — DELTA XTEND Reverse Shoulder System (February 19, 2021)
  • K203167 — DePuy Corail AMT Hip Prosthesis (November 19, 2020)
  • K202472 — ACTIS Duofix Hip Prosthesis (October 21, 2020)
  • K201347 — DePuy ATTUNE™ Total Knee System (June 18, 2020)
  • K193540 — TRUMATCH Personalized Solutions (June 16, 2020)
  • K193398 — Summit DuoFix HA Coating (February 4, 2020)
  • K192919 — Pinnacle Duofix HA Acetabular Cup Prosthesis (November 26, 2019)
  • K192946 — DePuy Corail AMT Hip Prosthesis (November 26, 2019)

Other clearances for product code HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 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)