# K193312: UNIKO PointCloud™ Knee Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Unik Orthopedics, Inc.
- Decided: Aug 12, 2020 after 257 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K924630 (1993). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140027: Zimmer Patient Specific Instruments/ System/Planner, Materialise NV (2014) Summary page 4.
- K122053: Shapematch Cutting Guide, Stryker Corp. (2012) Summary page 4.

## Most influential descendants
- K240327: UNIKO PointCloud™ Knee Instruments (2024), 0 descendants of its own

## Indications for use
The UNIKO PointCloud™ Knee Instruments are intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The UNIKO PointCloud™ Knee Instruments are compatible with the femoral and tibial components of the DJO Surgical EMPWR 3D Knee System. The Indications for Use of the DJO Surgical EMPWR 3D Knee System remain the same as those cleared in the manufacturer’s clearance for the implant system.

Source page: https://510kreport.com/device/K193312
Methodology: https://510kreport.com/methodology