510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193312Substantially Equivalent

UNIKO PointCloud™ Knee Instruments

Unik Orthopedics, Inc, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193312 is the FDA 510(k) clearance record for UNIKO PointCloud™ Knee Instruments, a class II device, cleared for Unik Orthopedics, Inc. on under FDA product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer). FDA records list 2 510(k) clearances for Unik Orthopedics, Inc., from to . As of , FDA records show no recalls naming K193312.

Clearance record

Decision date
Received
(257 days to decision)
Product code
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation
21 CFR 888.3565
Device class
Class II
Review panel
Orthopedic
Applicant
Unik Orthopedics, Inc. 1701 Fortune Dr., Unit E, San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBH

Trailing 12 months
9 clearances under product code MBH in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MBH, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20262
October 20260