510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053293Substantially Equivalent

Encompass 10*17 and 12*17 Extended Press-Fit Hip Stems

Ortho Development Corp., Draper UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K053293 is the FDA 510(k) clearance record for ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS, a class II device, cleared for Ortho Development Corp. on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 64 510(k) clearances for Ortho Development Corp., from to . As of , FDA records show 2 recalls naming K053293.

Clearance record

Decision date
Received
(83 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
Ortho Development Corp. 12187 S. Business Park Dr., Draper UT
510(k) summary
Statement
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