# K230202: TMINI™ Miniature Robotic System

- Pathway: 510(k) (Traditional)
- Applicant: THINK Surgical, Inc.
- Decided: Apr 25, 2023 after 90 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: 14 generations back to K905070 (1991). 59 ancestors in all.
10 later devices descend 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)
- K182964: ROSA Knee System, Orthosoft Inc (D/B/A Zimmer Cas) (2019) Summary page 4.

## Most influential descendants
- K232802: TMINI™ Miniature Robotic System (2023), 9 descendants of its own
- K241031: TMINI Miniature Robotic System (TMINI 1.1) (2024), 8 descendants of its own
- K242264: TMINI Miniature Robotic System (2024), 7 descendants of its own
- K243285: TMINI Miniature Robotic System (2024), 6 descendants of its own
- K243481: TMINI Miniature Robotic System (2025), 5 descendants of its own

## Recalls of this device
- Feb 12, 2024 · Class II · Z-1318-2024: There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins a

## 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. It includes a handheld robotic device, an optical sensor navigation system and accessories, software system, surgical instruments and accessories. 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 to be used with the following knee replacement system(s) in accordance with the indications and contraindications: Enovis™ EMPOWR Knee System®.

Source page: https://510kreport.com/device/K230202
Methodology: https://510kreport.com/methodology