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510(k) K130895

REUNION RSA SHOULDER SYSTEM by Howmedica Osteonics Corp. — Product Code PHX

K130895 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "REUNION RSA SHOULDER SYSTEM". The FDA issued a decision of Substantially Equivalent on December 27, 2013. The device falls under product code PHX (Shoulder Prosthesis, Reverse Configuration), 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
December 27, 2013
Date Received
April 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoulder Prosthesis, Reverse Configuration
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

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)
  • 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)
  • K113409 — S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESS (February 15, 2012)

Other clearances for product code PHX

  • K260556 — Veritas Shoulder System (July 1, 2026)
  • K261683 — Augment Off-Axis Instrument System (June 16, 2026)
  • K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid (June 12, 2026)
  • K261016 — MSS - Humeral reverse liners extension (June 10, 2026)
  • K253992 — Veritas Reverse Total Shoulder System (May 7, 2026)
  • K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (April 15, 2026)
  • K260583 — Equinoxe® Shoulder System (April 14, 2026)
  • K254128 — InSet Reverse Total Shoulder System (April 13, 2026)
  • K253674 — Blueprint Patient-Specific Instrumentation (April 3, 2026)
  • K253624 — INHANCE™ Reverse Shoulder System (March 11, 2026)

FDA data resources