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510(k) K031165

PLUS ORTHOPEDICS CEMENTED HIP STEM by Plus Orthopedics — Product Code JDI

K031165 is an FDA 510(k) premarket notification submitted by Plus Orthopedics for the device "PLUS ORTHOPEDICS CEMENTED HIP STEM". The FDA issued a decision of Substantially Equivalent on June 6, 2003. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Plus Orthopedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2003
Date Received
April 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
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 JDI

  • K253434 — OSSTM Orthopedic Salvage System (July 1, 2026)
  • K252824 — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (March 12, 2026)
  • K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained L (July 31, 2025)
  • K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectr (October 21, 2024)
  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
  • K220216 — C-Stem AMT LE Prosthesis (July 22, 2022)
  • K213701 — Exeter® X3® RimFit® Cup (February 1, 2022)

FDA data resources