# K013106: 2 Piece Modular Hip Stem - Pathway: 510(k) (Traditional) - Applicant: Howmedica Osteonics Corp. - Decided: Apr 3, 2002 after 198 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: 37 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K921308 (1994). 13 ancestors in all. 101 later devices descend from it; 6 cite it directly. 0 of 115 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K983404: Type 3 Femoral Components, Howmedica Corp. (1998) Summary page 2. - K972893: Partnership Revision Femoral Stems, Howmedica Corp. (1997) Summary page 2. - K972228: Meridian Titanium Femoral Stems, Howmedica, Inc. (1997) Summary page 2. - K993768: Citation TMZF HA Stem, Howmedica Osteonics Corp. (2000) Summary page 2. ## Most influential descendants - K022549: Restoration Modular System (2002), 54 descendants of its own - K103479: Novel Tapered Hip Stem (2011), 53 descendants of its own - K120578: Accolade II Hip Stem (2012), 46 descendants of its own - K090757: Biomet Modular Femoral Revision System (2009), 37 descendants of its own - K123604: Abg Iii Monolithic Hip Stem (2013), 30 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 - Dec 30, 2009 · Not classified · Z-1102-2010: The Restoration Modular Hip Stem may have two different package labels. The 14 mm diameter stem may be labeled with both a size 14 mm diameter and a 26 mm diameter. - Jun 26, 2009 · Not classified · Z-2174-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2164-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2172-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2148-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2156-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2169-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2159-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2145-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2161-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2178-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2173-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2157-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2175-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2154-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2153-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2149-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2160-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2170-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2162-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2171-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2155-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2168-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2147-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2163-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2152-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2158-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2165-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2166-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2150-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2167-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2177-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. - Jun 26, 2009 · Not classified · Z-2151-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - Jun 26, 2009 · Not classified · Z-2146-2009: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, po - 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 - Dec 30, 2003 · Not classified · Z-0571-04: Restoration T3 Revision Hip System distal stem has demonstrated fractures. ## Indications for use The 2 Piece Modular Revision Stem Components are 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/K013106 Methodology: https://510kreport.com/methodology