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Mako Shoulder Application (1.0)

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

6

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K242373
Device name
Mako Shoulder Application (1.0)
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2024-08-09
Decision date
2024-11-07
Submission type
Traditional
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
OtherNavigation SystemOther
Primary application
Other
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 shoulder 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 patient imaging data-based model of the anatomy. These procedures include:
• Reverse Shoulder Arthroplasty (primary joint replacement)
The implants compatible with the system are:
• Aequalis PerFORM Reversed Glenoid (cementless)
• Aequalis PerFORM + Reversed Glenoid (cementless)

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 shoulder 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 patient imaging data-based model of the anatomy. These procedures include: • Reverse Shoulder Arthroplasty (primary joint replacement) The implants compatible with the system are: • Aequalis PerFORM Reversed Glenoid (cementless) • Aequalis PerFORM + Reversed Glenoid (cementless)

Device Description

Mako Shoulder Application. Major Components: Robotic Arm, Guidance Module, Camera Stand, cutting system, generic user laptop for pre-operative planning. Tools/accessories: Various reusable and disposable instruments. Image Use: CT.

Summary parsed at:2026-06-19 05:34:48 UTC

Predicate devices

6

K242373 references 6 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K242373 as a predicate