510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201157Substantially Equivalent

Prime BIOFOAM® Multi-Hole Shells

Microport Orthopedics Inc., Arlington TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201157 is the FDA 510(k) clearance record for Prime BIOFOAM® Multi-Hole Shells, a class II device, cleared for Microport Orthopedics, Inc. on under FDA product code MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous). FDA records list 38 510(k) clearances for Microport Orthopedics, Inc., from to . As of , FDA records show no recalls naming K201157.

Clearance record

Decision date
Received
(481 days to decision)
Product code
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Microport Orthopedics, Inc. 5677 Airline Rd., Arlington TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBL

Trailing 12 months

FDA records hold no clearances under product code MBL in the trailing twelve months.

FDA records show no clearances under product code MBL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MBL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260