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510(k) K182516

Comprehensive Nano Stemless Shoulder by Biomet Manufacturing Corp — Product Code PKC

K182516 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "Comprehensive Nano Stemless Shoulder". The FDA issued a decision of Substantially Equivalent on April 22, 2019. 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. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2019
Date Received
September 13, 2018
Clearance Type
Traditional
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 Biomet Manufacturing Corp

  • K230540 — Patient Specific Planning Solution™ 3D Bone Models (July 25, 2023)
  • K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (March 15, 2023)
  • K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner (November 4, 2021)
  • K202232 — Comprehensive Vault Reconstruction System (February 19, 2021)
  • K193038 — Comprehensive Shoulder System (October 28, 2020)
  • K181611 — Comprehensive Reverse Shoulder System (September 24, 2018)
  • K173411 — Comprehensive Segmental Revision System (SRS) (February 8, 2018)
  • K172502 — Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Co (January 3, 2018)
  • K163651 — ExpressBraid Graft Manipulation (February 17, 2017)
  • K152754 — COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) (May 16, 2016)

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