# K161592: Persona Partial Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Nov 3, 2016 after 147 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K810258 (1981). 55 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010685: Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular Surface), Zimmer, Inc. (2001) Summary page 5.
- K942263: Miller/Galante Precoat Unicompartmental Knee System, Zimmer, Inc. (1995) Summary page 5.
- K880155: Miller/Galante Precoat Unicompartmental Knee, Zimmer, Inc. (1988) Summary page 5.
- K122529: Zimmer Unicompartmental Knee System Vivacit-E Articular Surface, Zimmer, Inc. (2012) Summary page 5.
- K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 5.
- K971938: Repicci II Unicondylar Knee, Biomet, Inc. (1997) Summary page 5.
- K011954: Sulzer Orthopedics Allegretto Unicompartmental Knee, Sulzer Orthopedics, Inc. (2001) Summary page 5.

## Most influential descendants
- K212870: TLC Unicompartmental Knee System (2022), 2 descendants of its own
- K261609: Freedom Partial Knee System (2026), 0 descendants of its own
- K251771: Cambridge Partial Knee (2025), 0 descendants of its own
- K251834: Persona Partial Knee (2025), 0 descendants of its own
- 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 (2020), 0 descendants of its own

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1238-2018: Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
- Jul 5, 2017 · Class II · Z-0349-2018: Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during kn

## Indications for use
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/K161592
Methodology: https://510kreport.com/methodology