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510(k) K110399

GLADIATOR PLASMA CLASSIC HIP STEM by Wrightmedicaltechnologyinc — Product Code KWA

K110399 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "GLADIATOR PLASMA CLASSIC HIP STEM". The FDA issued a decision of Substantially Equivalent on May 10, 2011. 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. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2011
Date Received
February 11, 2011
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

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  • K190970 — PROSTEP™ TBI™ (Tailors Bunion Implant) System (August 13, 2019)
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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