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Mako Total Knee Application (3.0); Hybrid Tip Pointer

Mako Surgical Corp.

Country / Region:United States (US)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

1

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K250608
Device name
Mako Total Knee Application (3.0); Hybrid Tip Pointer
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2025-02-28
Decision date
2025-04-25
Submission type
Traditional
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Knee SurgeryNavigation System
Primary application
Knee Surgery
Classification source
AI classified

Indications for Use

The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:
• Total Knee Arthroplasty (TKA)
The implant systems compatible with the system:
• Triathlon Total Knee System (CR/CS/PS/PSR cemented and cementless primary)
• Triathlon Total Knee System (TS inserts cemented primary)

Intended Use

The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Total Knee Arthroplasty (TKA).

Device Description

The Mako Total Knee Application consists of a robotic arm, Stryker Q Guidance System, and cutting system. It includes various reusable and disposable instruments. The device is intended for use with CT imaging.

Summary parsed at:2026-06-19 05:21:20 UTC

Predicate devices

1

K250608 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K250608 as a predicate