# K990032: Modular Protusio Cup

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 18, 1999 after 43 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953578 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911718: M.a.R.a. (Modular Acetabular Reconstruction Syst), Biomet, Inc. (1991) Summary page 2.
- K921139: Healey Revision Component System, Biomet, Inc. (1992) Summary page 2.
- K971890: Recovery Protrusio Cage, Biomet, Inc. (1997) Summary page 2.
- K943549: Restoration Acetabular Cup, Osteonics Corp. (1994) Summary page 2.
- K960678: Burch/Schneider Reinforcement Cage, Intermedics Orthopedics (1996) Summary page 2.

## Most influential descendants
- K992359: MRS-Titan (2000), 0 descendants of its own

## Recalls of this device
- Nov 25, 2020 · Class II · Z-0627-2021: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

## Indications for use
The indications for the Modular Protrusio Cup are as follows: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of nonunion, femoral neck fractures, and throchanteric fractures of the proximal femur with head involvement, unmanageable using other techniques 5) Revision of failed joint construction or treatment

Source page: https://510kreport.com/device/K990032
Methodology: https://510kreport.com/methodology