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510(k) K183194

Arthrex Eclipse Shoulder Prosthesis System by Arthrex, Inc. — Product Code QHQ

K183194 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Eclipse Shoulder Prosthesis System". The FDA issued a decision of Substantially Equivalent on Jul 26, 2019. The device falls under product code QHQ (Total Shoulder Arthroplasty System), a Class II device regulated under 21 CFR 888.3660. Arthrex, Inc. has 352 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 26, 2019
Date Received
Nov 19, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Total Shoulder Arthroplasty System
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type
510(k)

To treat pain and lack of function in the shoulder.

Other clearances by Arthrex, Inc.

  • K262451 — Arthrex DynaNite Staples (Sep 1, 2026)
  • K262357 — Arthrex Bioabsorbable PushLock Suture Anchors (Aug 7, 2026)
  • K260624 — Arthrex Radial Head Replacement System (Jul 30, 2026)
  • K260018 — Arthrex FiberButton (Jun 26, 2026)
  • K260809 — Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System (Jun 25, 2026)
  • K253931 — Arthrex Bioabsorbable PushLock Suture Anchors (May 28, 2026)
  • K254215 — Arthrex Beaming System (May 8, 2026)
  • K260561 — Arthrex FiberTak Suture Anchor (Mar 20, 2026)
  • K252016 — Arthrex Humeral Nails (Mar 20, 2026)
  • K260405 — FiberTape Button (Mar 9, 2026)

FDA data resources