# K896048: S-Rom/Noiles Mark 3

- Pathway: 510(k) (Traditional)
- Applicant: Joint Medical Products Corp.
- Decided: Mar 14, 1990 after 147 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
71 later devices descend from it; 5 cite it directly.
2 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

## Recalls of this device
- Feb 24, 2014 · Class II · Z-1207-2014: DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The o
- Feb 24, 2014 · Class II · Z-1204-2014: DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿ Noiles Rotating Hinge Femur with Pin devices. The 
- Feb 24, 2014 · Class II · Z-1208-2014: DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The o
- Feb 24, 2014 · Class II · Z-1206-2014: DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The o
- Feb 24, 2014 · Class II · Z-1205-2014: DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿ Noiles Rotating Hinge Femur with Pin devices. The 
- Feb 24, 2014 · Class II · Z-1203-2014: DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿ Noiles Rotating Hinge Femur with Pin devices. The 

Source page: https://510kreport.com/device/K896048
Methodology: https://510kreport.com/methodology