510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K100048Substantially Equivalent

E1 Antioxidant Infused Technology

Biomet Manufacturing Corp, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100048 is the FDA 510(k) clearance record for E1 ANTIOXIDANT INFUSED TECHNOLOGY, a class II device, cleared for Biomet Manufacturing Corp on under FDA product code OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive). FDA's definition for product code OIY reads: "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...". FDA records list 128 510(k) clearances for Biomet Manufacturing Corp, from to . As of , FDA records show no recalls naming K100048.

Clearance record

Decision date
Received
(60 days to decision)
Product code
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet Manufacturing Corp P.O. Box 587, Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OIY

Trailing 12 months
1 clearance under product code OIY in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OIY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260