Home / 510(k) Clearances / K220731

510(k) K220731

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem by Stryker — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2022
Date Received
March 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Stryker

  • K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (February 3, 2026)
  • K253202 — Hoffmann LRF System (December 19, 2025)
  • K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (August 20, 2025)
  • K250163 — T2 Alpha Femur Retrograde Nailing System (August 13, 2025)
  • K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pan (October 6, 2024)
  • K233919 — VariAx 2 Distal Radius System (March 25, 2024)
  • K233741 — Hoffmann LRF System (December 21, 2023)
  • K230045 — HipCheck (September 29, 2023)
  • K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with (September 20, 2023)
  • K231257 — Pangea Utility Plating System, Pangea Platform (August 18, 2023)

Other clearances for product code MEH

  • K250375 — Allure Hip Stem and Intramedullary Plugs (November 5, 2025)
  • K251166 — Mfinity Femoral System (June 13, 2025)
  • K251052 — Trivicta® Hip Stem (May 22, 2025)
  • K242315 — Resolve Modular Revision Hip Stem (May 1, 2025)
  • K243839 — Alteon® HA Femoral Stems (March 10, 2025)
  • K243162 — World Liner (November 25, 2024)
  • K241472 — Icona Hip Stem (October 3, 2024)
  • K241875 — TheRay Collared and Collarless Femoral Stem (September 13, 2024)
  • K241690 — Logical Liner; World Liner; World Knee Patella (August 1, 2024)
  • K233758 — Trivicta™ Hip Stem (March 8, 2024)