# K970498: Natural-Knee II Revision Femoral Spacer Lugs

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Apr 30, 1997 after 79 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- 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
No predicates in its family tree.
6 later devices descend from it; 1 cites 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) Smith & Nephew Richards Genesis and Tricon-M FlexLok Pegs: named in the summary without a submission number
- (no number) Smith & Nephew Richards Genesis Modular Femoral Lugs: named in the summary without a submission number
- (no number) Howmedica Duracon Modular Femoral Pegs: 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

## Indications for use
The Natural-Knee II Revision Femoral Spacer Lugs are intended for cemented use with the previously cleared Natural-Knee II Revision Femoral Component and associated components (e.g., tibial, patellar, etc.) in the treatment of: 1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., theumatoid arthritis. 2. Correctable valgus-varus deformity and moderate flexion contracture. 3. Those patients with failed previous surgery where pain, deformity or dysfunction persists. 4, Revision of previously failed knee arthroplasty.

Source page: https://510kreport.com/device/K970498
Methodology: https://510kreport.com/methodology