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TMINI Miniature Robotic System

THINK Surgical, Inc.

Country / Region:United States (US)Submission type:Special

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

1

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K253661
Device name
TMINI Miniature Robotic System
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2025-11-20
Decision date
2025-12-22
Submission type
Special
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Knee Surgery
Primary application
Knee Surgery
Classification source
AI classified

Indications for Use

TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools. The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System. The TMINI® Miniature Robotic System is compatible with and to be used with the following knee replacement systems in accordance with the indications and contraindications: • Enovis™ EMPOWR Knee System® • Ortho Development® BKS® and BKS TriMax® Knee System • Total Joint Orthopedics Klassic® Knee System • United® U2™ Total Knee System • Medacta® GMK® Sphere / SpheriKA Knee Systems • Zimmer Biomet Anterior & Posterior Referencing Persona® Knee • b-ONE MOBIO® Total Knee System • Maxx Orthopedics Freedom® Total & Titan Knee • LINK® LinkSymphoKnee System • Stryker® Triathlon® Knee System

Intended Use

TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools. The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System. The TMINI® Miniature Robotic System is compatible with and to be used with the following knee replacement systems in accordance with the indications and contraindications: • Enovis™ EMPOWR Knee System® • Ortho Development® BKS® and BKS TriMax® Knee System • Total Joint Orthopedics Klassic® Knee System • United® U2™ Total Knee System • Medacta® GMK® Sphere / SpheriKA Knee Systems • Zimmer Biomet Anterior & Posterior Referencing Persona® Knee • b-ONE MOBIO® Total Knee System • Maxx Orthopedics Freedom® Total & Titan Knee • LINK® LinkSymphoKnee System • Stryker® Triathlon® Knee System

Device Description

The TMINI® Miniature Robotic System consists of planning, web-based plan review, and robot control software, a robotic positioning device, a navigation system, and reusable and disposable instrumentation.

Summary parsed at:2026-06-19 05:25:49 UTC

Predicate devices

1

K253661 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K253661 as a predicate