510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K963101Substantially Equivalent

B-P Hemispherical Acetabular Component

Endotec, Inc., South Orange NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963101 is the FDA 510(k) clearance record for B-P HEMISPHERICAL ACETABULAR COMPONENT, a class II device, cleared for Endotec, Inc. on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 15 510(k) clearances for Endotec, Inc., from to . As of , FDA records show one recall naming K963101.

Clearance record

Decision date
Received
(187 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
Endotec, Inc. 20 Valley St., South Orange NJ
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