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510(k) K111097

HUMELOCK CEMENTED SHOULDER PROSTHESIS by Fx Solutions — Product Code HSD

K111097 is an FDA 510(k) premarket notification submitted by Fx Solutions for the device "HUMELOCK CEMENTED SHOULDER PROSTHESIS". The FDA issued a decision of Substantially Equivalent on November 9, 2011. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Fx Solutions has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2011
Date Received
April 20, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class
Class II
Regulation Number
888.3690
Review Panel
OR
Submission Type

Other clearances by Fx Solutions

  • K163669 — Humeris Shoulder (May 17, 2017)
  • K162455 — Humelock Reversed Shoulder (January 17, 2017)
  • K150488 — Humelock II Reversible Shoulder System (November 13, 2015)
  • K143721 — PRCT2 (August 27, 2015)
  • K140071 — HUMELOCK II CEMENTED SHOULDER SYSTEM (July 28, 2014)
  • K130759 — HUMELOCK II CEMENTLESS SHOULDER SYSTEM (November 9, 2013)
  • K123814 — HUMELOCK II CEMENTED SHOULDER SYSTEM (August 13, 2013)

Other clearances for product code HSD

  • K233260 — Univers Revers CA Head and Adapter (February 12, 2024)
  • K221232 — Univers Revers Humeral Cup Implant (May 19, 2022)
  • K191433 — AGILON® XO Shoulder Replacement System (November 12, 2020)
  • K193122 — Biocore9 Humeral Resurfacing System (May 15, 2020)
  • K173964 — OVOMotion Shoulder Arthroplasty System (April 18, 2018)
  • K161782 — Arthrex Univers Revers Shoulder Prosthesis System (November 21, 2016)
  • K161620 — Anatomical Shoulder Domelock Dome centric (November 1, 2016)
  • K151527 — Arthrex Univers Revers CA Heads and Adapters (April 19, 2016)
  • K142942 — HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System (December 19, 2014)
  • K131298 — EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (November 26, 2013)

FDA data resources