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510(k) K121056

METS MODULAR PROXIMAL FEMUR by Stanmore Implants Worldwide , Ltd. — Product Code JDI

K121056 is an FDA 510(k) premarket notification submitted by Stanmore Implants Worldwide , Ltd. for the device "METS MODULAR PROXIMAL FEMUR". The FDA issued a decision of Substantially Equivalent on September 20, 2012. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Stanmore Implants Worldwide , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2012
Date Received
April 6, 2012
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 Stanmore Implants Worldwide , Ltd.

  • K140898 — PATIENT SPECIFIC DISTAL FEMORAL (January 20, 2015)
  • K133152 — JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (January 22, 2014)
  • K121765 — SCULPTOR ROBOTIC GUIDANCE ARM (RGA) (January 11, 2013)
  • K121029 — METS MODULAR DISTAL FEMUR (September 19, 2012)
  • K121055 — METS MODULAR TOTAL FEMUR (September 19, 2012)
  • K120992 — METS SMILES TOTAL KNEE REPLACEMENT (September 5, 2012)
  • K092138 — JTS EXTENDEABLE IMPLANT (March 22, 2011)

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