Manufacturer
Mako Surgical Corp.Mako Total Knee Application
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
- K241011
- 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
- 2024-04-12
- Decision date
- 2024-06-11
- 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
Mako Total Knee Application consists of a robotic arm, Stryker Q Guidance System, cutting system, robotic arm, guidance module, camera stand, cutting system, and preoperative planning laptop. It includes various reusable and disposable instruments.
Summary parsed at:2026-06-19 05:32:34 UTC
Predicate devices
2Mako Total Knee Application
Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System
K241011 references 2 predicate/reference devices
Cited as predicate
4Q Guidance System; Mako Spine System;
Mako Total Hip Application 5.0
Mako Total Knee Application (3.0); Hybrid Tip Pointer
RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
4 submissions cite K241011 as a predicate