# K240327: UNIKO PointCloud™ Knee Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Unik Orthopedics, Inc.
- Decided: Jun 27, 2024 after 146 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K924630 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122053: Shapematch Cutting Guide, Stryker Corp. (2012) Summary page 4.
- K193312: UNIKO PointCloud™ Knee Instruments, Unik Orthopedics, Inc. (2020) Summary page 4.

## 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 intraoperatively 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 MRI scans. The UNIKO PointCloud™ Knee Instruments are compatible with the femoral and tibial components of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System. The Indications for Use of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System remain the same as those cleared in the manufacturer’s clearances for the implant system.

Source page: https://510kreport.com/device/K240327
Methodology: https://510kreport.com/methodology