# K022549: Restoration Modular System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 23, 2002 after 53 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921308 (1994). 14 ancestors in all.
54 later devices descend from it; 6 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013106: 2 Piece Modular Hip Stem, Howmedica Osteonics Corp. (2002)

## Most influential descendants
- K090757: Biomet Modular Femoral Revision System (2009), 37 descendants of its own
- K092331: Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110; (2010), 27 descendants of its own
- K032380: Wagner Cone Prosthesis (2003), 24 descendants of its own
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K113556: Wagner Cone Prosthesis System (2012), 9 descendants of its own

## Recalls of this device
- Apr 2, 2012 · Class II · Z-2487-2012: Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and
- Apr 2, 2009 · Not classified · Z-1642-2009: Packaging burst test values for the Restoration Modular Cone Body family were found to be incorrectly transferred from the finalized validation to the work specification. Testing showed that burst tes
- Nov 21, 2008 · Not classified · Z-0884-2009: Stryker became aware of a lot for lot mix up.

## Indications for use
The RestorationTMModular System is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular Components. These femoral stems are designed to be press fit into the proximal femur.

Source page: https://510kreport.com/device/K022549
Methodology: https://510kreport.com/methodology