Manufacturer
Mako Surgical Corp.Mako Total Knee Application
Country / Region:United States (US)Submission type:Special
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
- K260222
- Device name
- Mako Total Knee Application
- Company
- Mako Surgical Corp.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2026-01-26
- Decision date
- 2026-02-25
- Submission type
- Special
- 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 indicated for use in surgical total 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)
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 total 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
Mako Total Knee Application – Major Components: Robotic arm, Stryker Q Guidance System, cutting system. Tools/accessories: Various reusable and disposable instruments. Image Use: CT.
Summary parsed at:2026-06-19 04:31:28 UTC
Predicate devices
2Mako Total Knee Application (3.0); Hybrid Tip Pointer
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Not ingested
K260222 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K260222 as a predicate