# K013031: Most Options System

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Dec 7, 2001 after 88 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sulzer Orthopedics MOST™ System: named in the summary without a submission number
- (no number) Johnson & Johnson S-ROM® Noiles™ Rotating Hinge Knee System: named in the summary without a submission number
- (no number) Howmedica Osteonics® Modular Rotating Hinge Knee (MRS): named in the summary without a submission number

## Most influential descendants
- K173057: Zimmer Knee Joint Replacement Prostheses MR Labeling (2018), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K191625: Persona Revision Knee System (2019), 1 descendant of its own
- K243724: Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (2025), 0 descendants of its own
- K210829: Persona Revision Knee System Femoral Metaphyseal Cones (2021), 0 descendants of its own

## Recalls of this device
- Feb 25, 2014 · Class II · Z-1250-2014: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a
- Jan 29, 2009 · Not classified · Z-0996-2009: The package contains 11 mm screws instead of the specified 6 mm screws.
- Dec 17, 2004 · Not classified · Z-0539-05: Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.

## Indications for use
The MOST System is intended to replace the proximal, distal or total femur and/or the proximal tibia, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and possible resurfacing of the patella, if necessary. Proximal femoral replacement components are available for press-fit or cemented applications. Components used for replacement of the distal femur and proximal tibia are intended for cemented use only. Specific diagnostic indications for use of the MOST include: 1. metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors ) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur and/or proximal tibia; 2. patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory (1JD), e.g. rheumatoid arthritis, requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur and/or proximal tibia; and 3. revision cases requiring resection(s) and replacement(s) of the proximal, distal or total femur and/or proximal tibia.

Source page: https://510kreport.com/device/K013031
Methodology: https://510kreport.com/methodology