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510(k) K051995

PROFEMUR RENAISSANCE HIP STEM by Wrightmedicaltechnologyinc — Product Code JDL

K051995 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "PROFEMUR RENAISSANCE HIP STEM". The FDA issued a decision of Substantially Equivalent on August 22, 2005. The device falls under product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3320. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2005
Date Received
July 25, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3320
Review Panel
OR
Submission Type

Other clearances by Wrightmedicaltechnologyinc

  • K222835 — Prophecy Preoperative Navigation Alignment System (January 27, 2023)
  • 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 JDL

  • K073499 — VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES (August 7, 2008)
  • K070785 — DYNASTY ACETABULAR SYSTEM (July 11, 2007)
  • K061844 — DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER (December 6, 2006)
  • K051348 — CONSERVE TOTAL FEMORAL HEAD (August 19, 2005)
  • K042841 — M2A/C2A ACETABULAR SYSTEM (December 21, 2004)
  • K041586 — PROFEMUR S HIP STEM (July 9, 2004)
  • K041114 — PROFEMUR TAPERED HIP STEM (May 28, 2004)
  • K004043 — METAL TRANSCEND ARTICULATION SYSTEM (July 13, 2001)
  • K950542 — METAL BACKED ACETABULAR COMPONENT (May 25, 1995)
  • K944769 — P.F.C. APICAL PLUG (December 8, 1994)

FDA data resources