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510(k) K082146

METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD by Aesculap Implant Systems, Inc. — Product Code LWJ

K082146 is an FDA 510(k) premarket notification submitted by Aesculap Implant Systems, Inc. for the device "METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on September 9, 2008. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Aesculap Implant Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2008
Date Received
July 30, 2008
Clearance Type
Special
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 Aesculap Implant Systems, Inc.

  • K213871 — Ennovate Cervical Spinal and Occiput System (July 1, 2022)
  • K210963 — ENNOVATE Spinal System (July 19, 2021)
  • K180433 — ENNOVATE® (April 26, 2018)
  • K162134 — ENNOVATE Spinal System (December 14, 2016)
  • K153700 — Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments (July 8, 2016)
  • K153629 — ArcadiusXP C Spinal System (May 25, 2016)
  • K153396 — Aesculap OrthoPilot Next Generation (May 16, 2016)
  • K151938 — S4 Cervical Spinal and Occiput Systems (October 21, 2015)
  • K151056 — Aesculap T-Space PEEK and XP Spinal System (August 13, 2015)
  • K150544 — Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System (May 29, 2015)

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)
  • 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)
  • K051826 — BETACONE HIP PROSTHESIS SYSTEM (November 18, 2005)
  • K050262 — U2 ACETABULAR COMPONENT (August 15, 2005)
  • K042344 — EXCIA TOTAL HIP SYSTEM (March 16, 2005)

FDA data resources