Manufacturer
Mako Surgical Corp.Mako Shoulder Application (1.0)
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K242373
- Device name
- Mako Shoulder Application (1.0)
- Company
- Mako Surgical Corp.
- 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—
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Not ingested
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Not ingested
—
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Not ingested
ExactechGPS Total Shoulder Application, Equinoxe Planning Software
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Not ingested
ROSA® Shoulder System
K242373 references 6 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K242373 as a predicate
