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510(k) K051826

BETACONE HIP PROSTHESIS SYSTEM by Waldemar Link GmbH & Co. KG — Product Code LWJ

K051826 is an FDA 510(k) premarket notification submitted by Waldemar Link GmbH & Co. KG for the device "BETACONE HIP PROSTHESIS SYSTEM". The FDA issued a decision of Substantially Equivalent on November 18, 2005. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Waldemar Link GmbH & Co. KG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2005
Date Received
July 5, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Waldemar Link GmbH & Co. KG

  • K261009 — MobileLink Acetabular Cup System – 40mm ID Inserts (various) (July 6, 2026)
  • K250375 — Allure Hip Stem and Intramedullary Plugs (November 5, 2025)
  • K243927 — MobileLink Acetabular Cup System - inhouse coatings (May 16, 2025)
  • K241636 — MobileLink Acetabular Cup System - Line Extension (Multiple) (November 8, 2024)
  • K231445 — LINK Embrace Shoulder System - Reverse Configuration (November 16, 2023)
  • K222066 — LINK MobileLink Acetabular Cup System (April 14, 2023)
  • K230471 — LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface (March 21, 2023)
  • K213770 — SP-CL Hip Stem and LCU Hip System (September 13, 2022)
  • K221794 — Vario-Cup System (July 20, 2022)
  • K211567 — BiMobile Instruments (for BiMobile Dual Mobility System) (June 3, 2022)

Other clearances for product code LWJ

  • K120595 — UNISYN PLUS HIP STEM (October 12, 2012)
  • K103518 — TRINITY ACETABULAR SYSTEM (March 9, 2011)
  • K090764 — NOVATION CFS PRESS-FIT AND CEMENTED STEMS (April 21, 2009)
  • K082146 — METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD (September 9, 2008)
  • K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT (January 31, 2007)
  • K062978 — U2 HIP STEM, TI PLASMA SPRAY (January 16, 2007)
  • K062383 — UNISYN HA PLASMA MODULAR HIP (December 21, 2006)
  • K061699 — EXCIA (August 18, 2006)
  • K050262 — U2 ACETABULAR COMPONENT (August 15, 2005)
  • K042344 — EXCIA TOTAL HIP SYSTEM (March 16, 2005)

FDA data resources