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510(k) K100048

E1 ANTIOXIDANT INFUSED TECHNOLOGY by Biomet Manufacturing Corp — Product Code OIY

K100048 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "E1 ANTIOXIDANT INFUSED TECHNOLOGY". The FDA issued a decision of Substantially Equivalent on March 9, 2010. The device falls under product code OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive), a Class II device regulated under 21 CFR 888.3560. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2010
Date Received
January 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.

Other clearances by Biomet Manufacturing Corp

  • K230540 — Patient Specific Planning Solution™ 3D Bone Models (July 25, 2023)
  • K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (March 15, 2023)
  • K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner (November 4, 2021)
  • K202232 — Comprehensive Vault Reconstruction System (February 19, 2021)
  • K193038 — Comprehensive Shoulder System (October 28, 2020)
  • K182516 — Comprehensive Nano Stemless Shoulder (April 22, 2019)
  • K181611 — Comprehensive Reverse Shoulder System (September 24, 2018)
  • K173411 — Comprehensive Segmental Revision System (SRS) (February 8, 2018)
  • K172502 — Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Co (January 3, 2018)
  • K163651 — ExpressBraid Graft Manipulation (February 17, 2017)

Other clearances for product code OIY

  • K252887 — DePuy ATTUNE™ Knee System (May 22, 2026)
  • K242665 — DePuy ATTUNE™ Total Knee System (November 1, 2024)
  • K201347 — DePuy ATTUNE™ Total Knee System (June 18, 2020)
  • K120038 — A200 KNEE SYSTEM (February 14, 2013)
  • K121727 — MOVATION KNEE SYSTEM (August 15, 2012)
  • K113756 — HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELL (March 14, 2012)
  • K111433 — DEPUY STTUNE (TM) PS KNEE SYSTEM (August 30, 2011)
  • K103756 — DEPUY ATTUNE TOTAL KNEE SYSTEM (March 15, 2011)
  • K103223 — HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS (December 21, 2010)
  • K101433 — DEPUY ATTUNE KNEE SYSTEM (December 10, 2010)

FDA data resources