# K193233: Restoration® Modular Hip System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)
- Decided: May 27, 2020 after 184 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K921308 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121308: Hip Systems, Howmedica Osteonics Corp. (2012) Summary page 6.
- K022549: Restoration Modular System, Howmedica Osteonics Corp. (2002) Summary page 6.
- K013106: 2 Piece Modular Hip Stem, Howmedica Osteonics Corp. (2002) Summary page 6.

## Indications for use
Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed; and, Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indications specific to the Restoration Modular Hip System: The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.

Source page: https://510kreport.com/device/K193233
Methodology: https://510kreport.com/methodology