VERASENSE for Zimmer Biomet Persona— 510(k) K180459

Clearance details

Applicant

Orthosensor, Inc.

Product code

Code ONN

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2018-02-20

Decision date

2018-06-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Dania Beach, FL, US

• K262253 — Lantern Knee Navigation Unit (406000-03); Lantern Hip Navigation Unit (502000-03)2026-07-31
• K253507 — Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee2026-06-02
• K252524 — Quadsense (Quadsense and Quadsense Pro)2025-09-09
• K241298 — QUADSENSE2024-10-04
• K242616 — Lantern® Hip2024-10-03

• K200587 — VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder2020-08-25
• K200665 — VERASENSE for Stryker Triathlon2020-04-12
• K193580 — VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left2020-04-01
• K150372 — VERASENSE Knee System2016-04-15
• K131767 — ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM2013-11-08

• Z-0082-2019 — OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.Class II·Terminated·Orthosensor, Inc.·20180712
• Z-0083-2019 — OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.Class II·Terminated·Orthosensor, Inc.·20180712
• Z-0084-2019 — OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.Class II·Terminated·Orthosensor, Inc.·20180712
• Z-0085-2019 — OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.Class II·Terminated·Orthosensor, Inc.·20180712
• Z-0086-2019 — OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.Class II·Terminated·Orthosensor, Inc.·20180712
• Z-0087-2019 — OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.Class II·Terminated·Orthosensor, Inc.·20180712

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180459.