Home / 510(k) Clearances / K173964

510(k) K173964

OVOMotion Shoulder Arthroplasty System by Arthrosurface, Inc. — Product Code HSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2018
Date Received
December 29, 2017
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 Arthrosurface, Inc.

  • K203375 — OVOMotion Reverse Shoulder Arthroplasty System (June 24, 2021)
  • K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System (October 15, 2020)
  • K190261 — BOSS Toe Fixation System (August 14, 2019)
  • K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System (June 14, 2018)
  • K172383 — Arthrosurface Bone Screws (December 22, 2017)
  • K170440 — KISSloc Suture System (May 3, 2017)
  • K170350 — ToeMATE® Hammertoe Correction System (March 3, 2017)
  • K162391 — AlignMATE™ Lapidus Arthrodesis System (February 21, 2017)
  • K161539 — Arthrosurface Bone Screws (June 30, 2016)
  • K152454 — HemiCAP MTP Resurfacing Hemi-Arthroplasty System (April 11, 2016)

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)
  • 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)
  • K130759 — HUMELOCK II CEMENTLESS SHOULDER SYSTEM (November 9, 2013)