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510(k) K203100

Arthrex Eclipse Titanium Humeral Head by Arthrex, Inc. — Product Code PKC

K203100 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Eclipse Titanium Humeral Head". The FDA issued a decision of Substantially Equivalent on November 20, 2020. The device falls under product code PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained), a Class II device regulated under 21 CFR 888.3660. Arthrex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2020
Date Received
October 14, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Replacement of the humeral head for total anatomic shoulder arthroplasty

Other clearances by Arthrex, Inc.

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

Other clearances for product code PKC

  • K254154 — FX V135 EASYTECH® Shoulder System (May 1, 2026)
  • K252129 — AETOS Shoulder System Stemless Humeral Prosthesis (October 3, 2025)
  • K243248 — INHANCE INTACT™ (December 23, 2024)
  • K241873 — OsseoFit Stemless Shoulder System (December 11, 2024)
  • K240716 — AETOS Shoulder System Stemless Humeral Prosthesis (November 20, 2024)
  • K221758 — SMR Stemless Anatomic (March 17, 2023)
  • K220418 — Tornier Perform Humeral System – Stemless (September 14, 2022)
  • K213615 — Shoulder Innovations Total Shoulder System (March 11, 2022)
  • K212683 — GLOBAL ICON Stemless Shoulder System (January 19, 2022)
  • K203108 — Ignite Stemless Anatomic Shoulder System (July 16, 2021)

FDA data resources