510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041443Substantially Equivalent

Oti Alumina Ceramic Femoral Head System

Osteoimplant Technology, Inc., Hunt Valley MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K041443 is the FDA 510(k) clearance record for OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM, a class II device, cleared for Osteoimplant Technology, Inc. on under FDA product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented). FDA records list 21 510(k) clearances for Osteoimplant Technology, Inc., from to . As of , FDA records show no recalls naming K041443.

Clearance record

Decision date
Received
(168 days to decision)
Product code
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Osteoimplant Technology, Inc. 11201 Pepper Rd., Hunt Valley MD
510(k) summary
Statement
Third party review
No

Clearances, product code LZO

Trailing 12 months
8 clearances under product code LZO in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LZO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20262
April 20261
May 20260
June 20261
July 20261
August 20260
September 20262
October 20260