Home / 510(k) Clearances / K252225

510(k) K252225

PowerKnot High Strength Sutures by Medacta International S.A. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2025
Date Received
July 16, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Medacta International S.A.

  • K253328 — GMK 3D Metal Tibial Tray Extension (February 26, 2026)
  • K250644 — MSS - Monobloc stem (February 3, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252847 — NextAR Hip Platform (January 9, 2026)
  • K242603 — MyPAO SA guides (November 19, 2025)
  • K250338 — MSS - Humeral reverse liners extension (October 31, 2025)
  • K250450 — Coated hip implants (September 19, 2025)
  • K251737 — NextAR(TM) Shoulder Platform (September 4, 2025)
  • K250477 — NextAR(TM) Spine (July 31, 2025)
  • K241461 — Mpact Constrained Liner (July 31, 2025)

Other clearances for product code GAT

  • K254188 — Meniscus Versaflex (February 19, 2026)
  • K253145 — Pre-Sutured Tendon (October 22, 2025)
  • K253024 — ProZip Knotless Implant (October 16, 2025)
  • K252201 — HS Fiber (August 13, 2025)
  • K242201 — HyperSuture White/Green Extension Line (March 27, 2025)
  • K241376 — HyperSuture All Blue Extension Line (August 9, 2024)
  • K234079 — HyperSuture Extension Line (May 10, 2024)
  • K231163 — HS Fiber Sutures (January 5, 2024)
  • K230311 — HyperSuture (November 24, 2023)
  • K231183 — Non absorbable Surgical Polyester Suture (August 25, 2023)