# K230850: United Orthopedic Knee Patient Specific Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Enhatch, Inc.
- Decided: Dec 20, 2023 after 267 days
- Product code: OOG (Knee Arthroplasty Implantation System)
- 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171269: X-PSI Knee System, Orthosoft Inc (D/B/A Zimmer Cas) (2017) Summary page 5.
- K211244: VSP® Orthopedics System, 3D Systems (2021) Summary page 5.
- K051640: U2 Total Knee System, United Orthopedic Corp. (2006) Summary page 5.

## Indications for use
The United Orthopedic Knee Patient Specific Instrumentation is indicated as an orthopedic instrument system to assist in the positioning of compatible total knee arthroplasty systems. It is comprised of surgical planning software (Intelligent Surgery Knee CT Segmentation Engine/Knee X-ray Segmentation Engine, and Implant Recognition Engine) intended to preoperatively plan the surgical placement of the United Orthopedics Knee implants on the basis of provided patient radiological images and 3D reconstructions of bones with identifiable anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. The United Orthopedic Knee Patient Specific Instrumentation is indicated for patients without severe bone deformities, such as a HKA greater than 15° or deformities due to prior fracture of the distal femur or proximal tibia. The instruments are intended for use with the U2 Total Knee System when the clinical evaluation complies with its evaluation complies with its cleared indications for use. The instruments are intended for single use only.

Source page: https://510kreport.com/device/K230850
Methodology: https://510kreport.com/methodology