Home / 510(k) Clearances / K103835

510(k) K103835

REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N by Howmedica Osteonics Corp. — Product Code KWS

K103835 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N". The FDA issued a decision of Substantially Equivalent on May 5, 2011. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2011
Date Received
December 30, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Other clearances by Howmedica Osteonics Corp.

  • K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (August 13, 2020)
  • K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Tri (May 13, 2020)
  • K130895 — REUNION RSA SHOULDER SYSTEM (December 27, 2013)
  • K123604 — ABG III MONOLITHIC HIP STEM (August 16, 2013)
  • K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CI (February 22, 2013)
  • K123166 — TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON A (February 14, 2013)
  • K122853 — NOVEL FIT AND FILL STEM (February 1, 2013)
  • K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (November 1, 2012)
  • K121308 — HIP SYSTEMS (July 30, 2012)
  • K120578 — ACCOLADE II HIP STEM (March 29, 2012)

Other clearances for product code KWS

  • K254084 — AETOS Shoulder System - CONCELOC Glenoids (April 6, 2026)
  • K252418 — Catalyst F1x Shoulder System (November 6, 2025)
  • K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0 (October 29, 2025)
  • K241292 — MyShoulder Planner (5.3SSWPL) (January 30, 2025)
  • K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral Sys (December 6, 2024)
  • K241609 — Tornier Humeral Reconstruction System (Tornier HRS) (September 10, 2024)
  • K230513 — Arthrex Univers Apex OptiFit Humeral Stem (September 26, 2023)
  • K222592 — AltiVate® Anatomic Shoulder AG e+™ with Markers (June 23, 2023)
  • K230572 — AETOS Shoulder System (June 7, 2023)
  • K220847 — AETOS Shoulder System (January 3, 2023)

FDA data resources