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510(k) K093513

IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM by Conformis, Inc. — Product Code NPJ

K093513 is an FDA 510(k) premarket notification submitted by Conformis, Inc. for the device "IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 16, 2009. The device falls under product code NPJ (Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Conformis, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2009
Date Received
November 13, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.

Other clearances by Conformis, Inc.

  • K232426 — Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) wi (September 8, 2023)
  • K223316 — Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous C (July 21, 2023)
  • K230846 — iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement Syste (July 17, 2023)
  • K231233 — Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS (May 26, 2023)
  • K231178 — ACTERA™ hip system (May 23, 2023)
  • K230844 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruc (April 27, 2023)
  • K221104 — Actera™ hip system (August 4, 2022)
  • K221404 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior S (July 26, 2022)
  • K221059 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior S (May 10, 2022)
  • K213389 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Im (November 10, 2021)

Other clearances for product code NPJ

  • K150307 — RESTORIS Multicompartmental Knee System (March 10, 2015)
  • K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (December 10, 2013)
  • K093056 — SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM (December 15, 2009)
  • K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM (June 17, 2009)
  • K070849 — DEPUY GCK FEMORAL AND TIBIAL COMPONENTS (June 26, 2007)
  • K061648 — DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (September 11, 2006)
  • K061569 — SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS (July 6, 2006)
  • K053488 — CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM (March 9, 2006)
  • K052917 — STRYKER COMPARTMENTAL KNEE SYSTEM (December 27, 2005)
  • K052265 — SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL (December 27, 2005)

FDA data resources