# K260010: TMINI® Miniature Robotic System

- Pathway: 510(k) (Traditional)
- Applicant: THINK Surgical, Inc.
- Decided: Mar 3, 2026 after 60 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: 23 generations back to K905070 (1991). 68 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253661: TMINI Miniature Robotic System, THINK Surgical, Inc. (2025) Summary page 5.

## Most influential descendants
- K261024: TMINI Miniature Robotic System (2026), 0 descendants of its own

## Recalls of this device
- May 8, 2026 · Class II · Z-2716-2026: Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.

## 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/K260010
Methodology: https://510kreport.com/methodology