Manufacturer
Mako Surgical Corp.Mako Total Knee Application (3.0); Hybrid Tip Pointer
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Device details
FDA 510(k) registration fields
- K number
- K250608
- Device name
- Mako Total Knee Application (3.0); Hybrid Tip Pointer
- Company
- Mako Surgical Corp.
- 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
1Mako Total Knee Application
K250608 references 1 predicate/reference device
Cited as predicate
1Mako Total Knee Application
1 submission cite K250608 as a predicate
