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510(k) K003250

FMP METAL/METAL ACETABULAR INSERT by Encore Orthopedics, Inc. — Product Code KWA

K003250 is an FDA 510(k) premarket notification submitted by Encore Orthopedics, Inc. for the device "FMP METAL/METAL ACETABULAR INSERT". The FDA issued a decision of Substantially Equivalent on January 25, 2001. The device falls under product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3330. Encore Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2001
Date Received
October 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3330
Review Panel
OR
Submission Type

Other clearances by Encore Orthopedics, Inc.

  • K032905 — 3DKNEE POROUS COATED FEMORAL COMPONENT (July 6, 2004)
  • K020114 — 3D KNEE (July 12, 2002)
  • K020741 — UNICONDYLAR KNEE (June 4, 2002)
  • K020236 — MODIFICATION TO PASS SPINAL SYSTEM (February 14, 2002)
  • K020170 — KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP (February 11, 2002)
  • K013490 — CEMENTED CALCAR HIP SYSTEM (January 17, 2002)
  • K013442 — PASS SPINAL SYSTEM (January 15, 2002)
  • K003324 — PLASMA SPRAYED SHOULDER (December 6, 2001)
  • K013431 — PASS SPINAL SYSTEM (November 15, 2001)
  • K013191 — PASS SPINAL SYSTEM (October 24, 2001)

Other clearances for product code KWA

  • K122778 — PROFEMUR Z REVISION HIP STEM (October 11, 2012)
  • K121544 — DYNASTY BIOFOAM SHELL (July 30, 2012)
  • K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS (May 18, 2012)
  • K113322 — CONSERVE THIN SHELL (February 3, 2012)
  • K112080 — PRESERVE HIP STEM (December 28, 2011)
  • K112150 — PROFEMUR GLADIATOR HA HIP STEM (November 23, 2011)
  • K113019 — PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER (November 10, 2011)
  • K111910 — GLADIATOR HIP STEM (October 14, 2011)
  • K110836 — CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY (October 7, 2011)
  • K110400 — TAPERLOC COMPLETE MICROPLASTY STEM (September 30, 2011)

FDA data resources