# K153345: Stryker Orthopaedics Hip Systems Labeling Update - Pathway: 510(k) (Traditional) - Applicant: Stryker Orthopaedics - Decided: May 25, 2016 after 188 days - Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented) - Device class: 2 - Regulation: 21 CFR 888.3358 - 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: 8 generations back to K921308 (1994). 117 ancestors in all. 17 later devices descend from it; 8 cite it directly. 0 of 135 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K011623: Exeter Hip System with V40 Taper, Howmedica Osteonics Corp. (2001) Summary page 32. - K031730: 36MM Orthinox V40 Femoral Head Components, Howmedica Osteonics Corp. (2003) Summary page 32. - K110290: Exeter Hip Stem, Howmedica Osteonics Corp. (2011) Summary page 32. - K121308: Hip Systems, Howmedica Osteonics Corp. (2012) Summary page 32. - K041170: Secur-Fit HA and Secur-Fit Plus Hip Stems, Howmedica Osteonics Corp. (2004) Summary page 32. - K051738: Secur-Fit Max and Plus Max Hip Stems, Howmedica Osteonics Corp. (2005) Summary page 32. - K022555: Accolade C Femoral Stems, Howmedica Osteonics Corp. (2002) Summary page 32. - K994366: TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem, Howmedica Osteonics Corp. (2000) Summary page 32. - K020572: Accolade TMZF HA 132 Degree Size 0 Hip Stem, Howmedica Osteonics Corp. (2002) Summary page 32. - K023102: Accolade TMZF Plus HA 127 Size 0 Hip Stem, Howmedica Osteonics Corp. (2002) Summary page 32. - K051741: Accolade HFX Femoral Stem, Stryker Orthopaedics (2005) Summary page 32. - K103479: Novel Tapered Hip Stem, Stryker Corp. (2011) Summary page 32. - K120578: Accolade II Hip Stem, Howmedica Osteonics (2012) Summary page 32. - K143085: Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach, Stryker Orthopaedics (2015) Summary page 32. - K122853: Novel Fit and Fill Stem, Howmedica Osteonics Corp. (2013) Summary page 32. - K123604: Abg Iii Monolithic Hip Stem, Howmedica Osteonics Corp. (2013) Summary page 32. - K031744: Omnifit HFX Hip Stem Series, Howmedica Osteonics Corp. (2003) Summary page 32. - K983226: Osteonics X Cemented Hip Stem Series, Osteonics Corp. (1998) Summary page 32. - K013676: Trident Hemispherical Acetabular Shells, Howmedica Osteonics Corp. (2001) Summary page 32. - K081171: Tritanium Acetabular Shell System, Howmedica Osteonics Corp. (2008) Summary page 32. - K142462: Restoration Anatomic Shell, Stryker Orthopaedics (2014) Summary page 33. - K151264: Restoration Anatomic Shell, Stryker Orthopaedics (2015) Summary page 33. - K010170: Trident Porous Titanium Acetabular Component, Howmedica Osteonics Corp. (2001) Summary page 33. - K983502: Osteonics Secur-Fit AD Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 33. - K983382: Osteonics HA Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 33. - K040412: Trident T Acetabular Shells, Stryker Orthopaedics (2004) Summary page 33. - K072020: Restoration Adm System, Howmedica Osteonics Corp. (2007) Summary page 33. - K102019: Restoration Acetabular Wedge Augments, Howmedica Osteonics (2011) Summary page 33. - K920868: Acetabular Dome and Screw Hole Plugs, Osteonics Corp. (1992) Summary page 33. - K942809: Acetabular Dome Hole Plugs, Osteonics Corp. (1994) Summary page 33. - K103233: Modular Dual Mobility Liner, X3 Acetabular Insert, Howmedica Osteonics Corp. (2011) Summary page 33. - K093644: Restoration Adm System X3 Acetabular, Howmedica Osteonics Corp. (2009) Summary page 33. - K033716: Trident Acetabular System, Howmedica Osteonics Corp. (2005) Summary page 33. - K061434: Trident Large Diameter Hip System, Howmedica Osteonics Corp. (2006) Summary page 33. - K062419: Trident Large Diameter Acetabular Inserts, Howmedica Osteonics Corp. (2006) Summary page 33. - K991952: Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts, Howmedica Osteonics Corp. (1999) Summary page 33. - K021911: Trident Crossfire Polyuethylene Liners, Howmedica Osteonics Corp. (2002) Summary page 33. - K020497: Trident Elevated Rim Liner, Howmedica Osteonics Corp. (2002) Summary page 33. - K061654: Trident Constrained Acetabular Insert, Howmedica Osteonics Corp. (2006) Summary page 33. - P960047: Osteonics Constrained Acetabular Insert, Howmedica Osteonics Corp. (1997) Summary page 33. - K052718: V40 Biolox Delta Ceramic Femoral Heads, Howmedica Osteonics Corp. (2005) Summary page 33. - K070885: Universal Taper Delta Femoral Head, Howmedica Osteonics Corp. (2007) Summary page 33. - K041940: Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral Heads, Howmedica Osteonics Corp. (2005) Summary page 33. - K051588: Biolox Delta Ceramic Femoral Heads, Howmedica Osteonics Corp. (2005) Summary page 33. - K993601: Howmedica Osteonics Femoral Heads, Howmedica Osteonics Corp. (1999) Summary page 33. - K010757: Lfit V40 Femoral Head Components, Howmedica Osteonics Corp. (2001) Summary page 33. - K022077: 36MM V40 Femoral Head Components (Lfit and Non-Lfit), Howmedica Osteonics Corp. (2002) Summary page 33. - K900836: Osteonics Ecsi Hip Stem Series, Osteonics Corp. (1990) Summary page 33. - K021310: 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit), Howmedica Osteonics Corp. (2002) Summary page 33. - K910988: Osteonics Ion Implanted Femoral Bearing Series, Osteonics Corp. (1991) Summary page 33. - K023901: Alumina V40 Femoral Heads, Howmedica Osteonics Corp. (2003) Summary page 33. - K971409: Osteonics Alumina C-Taper Head, Osteonics Corp. (1997) Summary page 33. - K003391: Osteonics Alumina C-Taper Head, Howmedica Osteonics Corp. (2000) Summary page 33. - K902365: Modular Unipolar System, Howmedica Corp. (1991) Summary page 33. - K014226: Unitrax Modular Unipolar System, Howmedica Osteonics Corp. (2002) Summary page 33. - K954077: Unitrax V40 Modular Adaptor, Howmedica Corp. (1995) Summary page 33. - K992570: Unitrax C-Taper Neck Adjustment Sleeve, Howmedica Osteonics Corp. (1999) Summary page 33. - K003379: V-40/C-Taper Adapter Sleeve, Howmedica Osteonics Corp. (2000) Summary page 33. - K051737: Modification to V-40/C-Taper Adapter Sleeve, Howmedica Osteonics Corp. (2005) Summary page 33. - K894124: Omnifit Self Tapping Cancellous Bone Screws, Osteonics Corp. (1989) Summary page 33. - K943549: Restoration Acetabular Cup, Osteonics Corp. (1994) Summary page 34. - K903362: Osteolock (TM) Acetabular Cup, Howmedica Corp. (1990) Summary page 34. - K914406: PT II Distal Cement Spacer, Osteonics Corp. (1991) Summary page 34. - (no number) Trident All Polyethylene Constrained Liner: named in the summary without a submission number ## Most influential descendants - K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own - K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own - K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own - K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (2020), 6 descendants of its own - K222632: UHR Bipolar Implants, Restoration GAP II Implants (2022), 5 descendants of its own ## Recalls of this device - Aug 18, 2016 · Class II · Z-0060-2017: Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner. ## Indications for use The document contains multiple Indications for Use forms, one for each device or device group. Their statements are reproduced in the document text. Source page: https://510kreport.com/device/K153345 Methodology: https://510kreport.com/methodology