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Mako Total Hip Application 5.0

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

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K243751
Device name
Mako Total Hip Application 5.0
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2024-12-05
Decision date
2025-03-05
Submission type
Traditional
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Other
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 total hip arthroplasty 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; including revision total hip arthroplasty procedures where:
• the primary acetabular component is well-fixed to the pelvic anatomy, and
• the acetabular component can be revised with either a cup or cup and wedge augment construct. These procedures include: Total Hip Arthroplasty (THA)

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 total hip arthroplasty 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; including revision total hip arthroplasty procedures where: • the primary acetabular component is well-fixed to the pelvic anatomy, and • the acetabular component can be revised with either a cup or cup and wedge augment construct. These procedures include: Total Hip Arthroplasty (THA)

Device Description

Mako Total Hip Application – Major Components: Stryker Q-Guidance System, robotic arm, cutting system, preoperative planning laptop. Tools/accessories: Various reusable and disposable instruments. Image Use: CT.

Summary parsed at:2026-06-19 05:16:18 UTC

Predicate devices

2

K243751 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K243751 as a predicate