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510(k) K030971

MODIFICATION TO MODULAR PLUS REVISION STEM by Plus Orthopedics — Product Code LWJ

K030971 is an FDA 510(k) premarket notification submitted by Plus Orthopedics for the device "MODIFICATION TO MODULAR PLUS REVISION STEM". The FDA issued a decision of Substantially Equivalent on April 24, 2003. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Plus Orthopedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2003
Date Received
March 28, 2003
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 Plus Orthopedics

  • K070928 — CERAMIC BALL HEADS, 28, 32 AND 36 MM (August 1, 2007)
  • K070731 — PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM (July 31, 2007)
  • K070278 — POLARCUP DUAL MOBILITY SYSTEM (April 16, 2007)
  • K063578 — PROMOS MODULAR SHOULDER SYSTEM (March 2, 2007)
  • K061362 — PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM (October 6, 2006)
  • K032126 — PROMOS SHOULDER (January 8, 2004)
  • K033763 — MODIFICATION TO SLIM GLIDING NAIL SYSTEM (December 18, 2003)
  • K032709 — MODULAR PLUS HIP STEM (September 23, 2003)
  • K032548 — IP-XS COMPRESSION NAIL SYSTEM (September 10, 2003)
  • K032215 — VKS/TC-PLUS REVISION KNEE (August 8, 2003)

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)
  • K051826 — BETACONE HIP PROSTHESIS SYSTEM (November 18, 2005)
  • K050262 — U2 ACETABULAR COMPONENT (August 15, 2005)

FDA data resources