# K973087: Most Hex Intramedullary (I/M) Stem

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Nov 14, 1997 after 88 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
64 later devices descend from it; 2 cite it directly.
2 of 65 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) Wright Medical Segmented Oncology System (S.O.S.): named in the summary without a submission number
- (no number) Waldermar Link MP Reconstruction Prosthesis: named in the summary without a submission number
- (no number) Johnson & Johnson/Joint Medical Products Noiles Knee System: named in the summary without a submission number
- (no number) Howmedica Kinematic II Rotating Hinge Knee System: named in the summary without a submission number

## Most influential descendants
- K003182: Orthogenesis LPS System (2001), 63 descendants of its own
- K040281: LPS Metaphyseal Sleeve (Limb Preservation System) (2004), 54 descendants of its own
- K060515: Depuy PFC Sigma Knee Prosthesis (2006), 36 descendants of its own
- K063633: Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves (2007), 31 descendants of its own
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own

## Indications for use
The MOST System is intended to replace the proximal, distal and/or total femur, especially in cases that require extensive resection and restoration. The Hex I/M Stem is intended for cemented use only in these situations. Specific diagnostic indications for use of the MOST System include: 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; patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (JD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal femur; patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment; revision cases requiring extensive resection(s) and replacement(s) of the proximal, distal, or total femur.

Source page: https://510kreport.com/device/K973087
Methodology: https://510kreport.com/methodology