Manufacturer
Mako Surgical Corp.Mako Total Hip Application 5.0
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
- K243751
- Device name
- Mako Total Hip Application 5.0
- Company
- Mako Surgical Corp.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2024-12-05
- 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—
—
Not ingested
Mako Total Knee Application
K243751 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 K243751 as a predicate
