Manufacturer
THINK Surgical, Inc.TMINI Miniature Robotic System
Country / Region:United States (US)Submission type:Special
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Device details
FDA 510(k) registration fields
- K number
- K253661
- Device name
- TMINI Miniature Robotic System
- Company
- THINK Surgical, Inc.
- 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
1TMINI Miniature Robotic System
K253661 references 1 predicate/reference device
Cited as predicate
1TMINI® Miniature Robotic System
1 submission cite K253661 as a predicate
