510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K113320Substantially Equivalent

Novation Element Femoral Stem, 12/14 Collarless Standard/high Offset Ha Coated Press-Fit, Sz 8-12

Exactech, Inc., Gainesville FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113320 is the FDA 510(k) clearance record for NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12, a class II device, cleared for Exactech, Inc. on under FDA product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate). FDA records list 186 510(k) clearances for Exactech, Inc., from to . As of , FDA records show no recalls naming K113320.

Clearance record

Decision date
Received
(127 days to decision)
Product code
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Exactech, Inc. 2320 NW 66th Ct., Gainesville FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEH

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