# K992403: MRP-Titan

- Pathway: 510(k) (Traditional)
- Applicant: Rotec Medizintechnik GmbH
- Decided: Jan 21, 2000 after 186 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
Longest line of descent: 3 generations back to K935452 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955296: Link MP Reconstruction Hip, Link America, Inc. (1996) Summary page 2.
- K961939: S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115), Johnson & Johnson Professionals, Inc. (1996) Summary page 2.

## Indications for use
Primary and revision arthroplasty: Revision of primary hip stem prostheses Fractures of the proximal femur Tumor situation of the proximal femur Reconstructions of the upper area of the proximal femur after both primary hip operation or traumafracture Recovery of leg-lengthening Improving antetorsion after failed primary hip stem operation

Source page: https://510kreport.com/device/K992403
Methodology: https://510kreport.com/methodology