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510(k) K233592

BioPoly Radial Head Implant by BioPoly, LLC — Product Code KWI

K233592 is an FDA 510(k) premarket notification submitted by BioPoly, LLC for the device "BioPoly Radial Head Implant". The FDA issued a decision of Substantially Equivalent on March 13, 2024. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. BioPoly, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2024
Date Received
November 8, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class
Class II
Regulation Number
888.3170
Review Panel
OR
Submission Type

Other clearances by BioPoly, LLC

  • K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant (November 22, 2022)
  • K203634 — BioPoly Great Toe Hemiarthroplasty Implant (February 2, 2021)

Other clearances for product code KWI

  • K231188 — ALIGN Radial Head System (September 28, 2023)
  • K213563 — DePuy Synthes Radial Head Replacement System (March 18, 2022)
  • K212872 — Avenger Radial Head System (December 17, 2021)
  • K192754 — Avenger Radial Head System (January 7, 2020)
  • K183618 — Revolution Radial Head (May 17, 2019)
  • K172688 — Align Radial Head System (December 22, 2017)
  • K132735 — AXIA RADIAL HEAD SYSTEM (January 7, 2014)
  • K131845 — ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUM (September 30, 2013)
  • K112030 — SYNTHES RADIAL HEAD PROSTHESIS SYSTEM (June 19, 2012)
  • K092721 — ALIGN RADIAL HEAD SYSTEM (August 3, 2010)

FDA data resources