# K971890: Recovery Protrusio Cage

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 7, 1997 after 77 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: 2 generations back to K953578 (1995). 4 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K953578: Protek Acetabular Roof Reinforcement Ring, Intermedics Orthopedics (1995) Summary page 2.
- K960678: Burch/Schneider Reinforcement Cage, Intermedics Orthopedics (1996) Summary page 2.
- K962007: Protrusion Cages, Depuy, Inc. (1996) Summary page 2.
- K943549: Restoration Acetabular Cup, Osteonics Corp. (1994) Summary page 2.

## Most influential descendants
- K990032: Modular Protusio Cup (1999), 1 descendant of its own
- 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 Recovery Protrusio Cage is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use in skeletally mature individuals undergoing primary or secondary revision surgery. The device is a single use implant. The device is to be used in conjunction with any commercially available polyethylene acetabular cup.

Source page: https://510kreport.com/device/K971890
Methodology: https://510kreport.com/methodology
