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510(k) K122778

PROFEMUR Z REVISION HIP STEM by Wrightmedicaltechnologyinc — Product Code KWA

K122778 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "PROFEMUR Z REVISION HIP STEM". The FDA issued a decision of Substantially Equivalent on October 11, 2012. 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
October 11, 2012
Date Received
September 11, 2012
Clearance Type
Special
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 Wrightmedicaltechnologyinc

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  • K213342 — PRO-DENSE LoVisc Bone Graft Substitute (January 5, 2022)
  • K212996 — Sterile PHALINX Hammertoe System (November 16, 2021)
  • K202815 — PROPHECY Preoperative Navigation Alignment System (March 10, 2021)
  • K201259 — ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System (January 8, 2021)
  • K200507 — PRO-DENSE LoVisc Bone Graft Substitute (October 21, 2020)
  • K193067 — The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISIO (June 8, 2020)
  • K191393 — INFINITY Total Ankle System, INBONE Total Ankle System (August 22, 2019)
  • K190970 — PROSTEP™ TBI™ (Tailors Bunion Implant) System (August 13, 2019)
  • K183620 — PROSTEP TBC Implant System (June 6, 2019)

Other clearances for product code KWA

  • 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)
  • K111699 — PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM (August 19, 2011)

FDA data resources