Home / 510(k) Clearances / K111145

510(k) K111145

ENDO HEAD by Medacta International — Product Code LZY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2011
Date Received
April 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Medacta International

  • 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)
  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K251737 — NextAR(TM) Shoulder Platform (September 4, 2025)
  • K241461 — Mpact Constrained Liner (July 31, 2025)

Other clearances for product code LZY

  • K231448 — TANDEM Hip System (July 19, 2023)
  • K974442 — PRE-POWDERED NITRILE EXAMINATION GLOVES (January 5, 1998)
  • K915528 — BHR BIPOLAR FEMORAL HEAD COMPONENT (June 29, 1993)
  • K915548 — IONGUARD TITANIUM MODULAR HEADS (March 10, 1992)
  • K903084 — MODULAR CATHCART FRACTURE SYSTEM (October 3, 1990)
  • K896580 — UNI-POLAR HEAD (February 15, 1990)
  • K892059 — FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR (July 19, 1989)