510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K951741Substantially Equivalent for Some Indications

Replica Total Hip System

Osteo-Technology Intl., Inc., Hunt Valley MD / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K951741 is the FDA 510(k) clearance record for REPLICA TOTAL HIP SYSTEM, a class II device, cleared for Osteo-Technology Intl., Inc. on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 3 510(k) clearances for Osteo-Technology Intl., Inc., from to . As of , FDA records show no recalls naming K951741.

Clearance record

Decision date
Received
(129 days to decision)
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Osteo-Technology Intl., Inc. 11201 Pepper Rd., Hunt Valley MD
Third party review
No

Clearances, product code LPH

Trailing 12 months
11 clearances under product code LPH in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LPH, trailing twelve months
MonthClearances
November 20252
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20261
August 20262
September 20261
October 20260