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510(k) K222501

Regeneten Bioinductive Implant by Smith and Nephew, Inc. — Product Code OWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2023
Date Received
August 18, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

For reinforcement of soft tissue where weakness exists in tendon repair.

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  • K243608 — TRIGEN Stable Lock Nut & Washer (June 12, 2025)
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  • K241666 — EVOS Pelvic and Acetabular System (February 19, 2025)
  • K243364 — TRIGEN META-TAN Trochanteric Antegrade Nail (December 9, 2024)
  • K240716 — AETOS Shoulder System Stemless Humeral Prosthesis (November 20, 2024)
  • K242711 — JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (October 30, 2024)

Other clearances for product code OWY

  • K251690 — Arthrex SpeedFLEX™ Implant (September 30, 2025)
  • K252647 — Tapestry Biointegrative Implant (September 19, 2025)
  • K250109 — TYBR Collagen Gel (June 6, 2025)
  • K243843 — Tendon Protect (50242) (June 4, 2025)
  • K242631 — REGENETEN™ Bioinductive Implant (November 26, 2024)
  • K220867 — Tapestry Biointegrative Implant (May 23, 2022)
  • K212306 — Tapestry Biointegrative Implant (November 2, 2021)
  • K201572 — TAPESTRY Biointegrative Implant (October 19, 2020)
  • K151083 — BioBridge Collagen Matrix (January 8, 2016)
  • K140300 — COLLAGEN TENDON SHEET-DDI (CTS-DDI) (March 26, 2014)