# K261024: TMINI Miniature Robotic System

- Pathway: 510(k) (Traditional)
- Applicant: THINK Surgical, Inc.
- Decided: Jul 24, 2026 after 116 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K905070 (1991). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K260010: TMINI® Miniature Robotic System, THINK Surgical, Inc. (2026) Summary page 5.

## Recalls of this device
- Aug 20, 2026 · Class II · Z-0192-2027: Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.

## 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

Source page: https://510kreport.com/device/K261024
Methodology: https://510kreport.com/methodology