510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091956Substantially Equivalent

Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712

Encore Medical, LP, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091956 is the FDA 510(k) clearance record for HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712, a class II device, cleared for Encore Medical L.P. 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 85 510(k) clearances for Encore Medical L.P., from to . As of , FDA records show 4 recalls naming K091956.

Clearance record

Decision date
Received
(454 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
Encore Medical L.P. 9800 Metric Blvd., Austin TX
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 October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OIY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260