# K992359: MRS-Titan

- Pathway: 510(k) (Traditional)
- Applicant: Rotec Medizintechnik GmbH
- Decided: Feb 18, 2000 after 219 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: 4 generations back to K953578 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963946: Osteonics Modular Acetabular Cup (Microstructured Version), Osteonics Corp. (1997) Summary page 3.
- K911718: M.a.R.a. (Modular Acetabular Reconstruction Syst), Biomet, Inc. (1991) Summary page 3.
- K971890: Recovery Protrusio Cage, Biomet, Inc. (1997) Summary page 3.
- K990032: Modular Protusio Cup, Biomet, Inc. (1999) Summary page 3.

## Indications for use
Painful, disabling joint diseases of the hip resulting from degeneration, arthritis, rheumatoid arthritis, post traumatic arthritis. Revision of previous unsuccessfull femoral head replacement, cup arthroplasty or other procedure. Clinical management problem solve arthrodesis or alternative techniques are less likely to achieve satisfactory results. Bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated deficiencies of the acetabulum.

Source page: https://510kreport.com/device/K992359
Methodology: https://510kreport.com/methodology