510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K200151Substantially Equivalent

Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200151 is the FDA 510(k) clearance record for Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill, a class II device, cleared for Zimmer, Inc. on under FDA product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K200151.

Clearance record

Decision date
Received
(55 days to decision)
Product code
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3520
Device class
Class II
Review panel
Orthopedic
Applicant
Zimmer, Inc. 1800 W. Center St., Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSX

Trailing 12 months
2 clearances under product code HSX in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HSX, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260