SMARTTOOLS KNEE SYSTEM— 510(k) K122326

Clearance details

Applicant

Zimmer

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2012-08-01

Decision date

2012-11-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Montreal, CA

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Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1868-2017 — SmartTools Knee System Orthopedic Stereotaxic InstrumentClass II·Terminated·Orthosoft, Inc. dba Zimmer CAS·20170220
• Z-1701-2015 — Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;Class II·Terminated·Zimmer CAS·20150419

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122326.