# K200151: Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 17, 2020 after 55 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K810258 (1981). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161592: Persona Partial Knee System, Biomet, Inc. (2016) Summary page 4.

## Indications for use
Indications for Persona Partial Knee System: The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications: - Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis; - traumatic arthritis; - previous tibial condyle or plateau fractures with loss of anatomy or function; - varus deformities; and - revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged. The Persona Partial Knee System is a single use implant intended for implantation with bone cement. Indications for combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ): - Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. - The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). - History of patellar dislocation or patella fracture. - Dysplasia-induced degeneration. These indications will be used for the combined medial unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions. Combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ) implants are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K200151
Methodology: https://510kreport.com/methodology