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510(k) K220717

RedPoint Medical's Better Bunion System by Redpoint Medical, LLC — Product Code PBF

K220717 is an FDA 510(k) premarket notification submitted by Redpoint Medical, LLC for the device "RedPoint Medical's Better Bunion System". The FDA issued a decision of Substantially Equivalent on June 9, 2022. The device falls under product code PBF (Orthopaedic Surgical Planning And Instrument Guides), a Class II device regulated under 21 CFR 888.3030.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2022
Date Received
March 11, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopaedic Surgical Planning And Instrument Guides
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.

Other clearances for product code PBF

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  • K250711 — VSP Orthopedics System (December 5, 2025)
  • K242603 — MyPAO SA guides (November 19, 2025)
  • K251709 — MedCAD® AccuStride™ System (November 4, 2025)
  • K250394 — Fine TTO™ (October 21, 2025)
  • K250767 — Newclip Patient-matched instrumentation non sterile PSI (October 1, 2025)
  • K250921 — CORIOGRAPH Pre-Op Planning and Modeling Services (June 25, 2025)
  • K241811 — MedCAD® AccuStride™ System (March 13, 2025)
  • K243912 — Newclip Patient-matched instrumentation non sterile PSI (February 13, 2025)
  • K240415 — Newclip Patient-matched instrumentation non sterile PSI (November 7, 2024)

FDA data resources