# K031693: Mallory/Head Modular Calcar with and Without HA - Pathway: 510(k) (Traditional) - Applicant: Biomet, Inc. - Decided: Aug 6, 2003 after 65 days - Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented) - Device class: 2 - Regulation: 21 CFR 888.3358 - Recalls of this device: 16 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K921274 (1994). 6 ancestors in all. 39 later devices descend from it; 2 cite it directly. 0 of 46 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K945115: Mallory-Head Modular Calcar Repacement Components, Biomet, Inc. (1995) Summary page 1. - K000760: Reach Femoral Component, Biomet, Inc. (2000) - K001660: Mallory Head Modular Calcar, Biomet Orthopedics, Inc. (2000) - K022463: HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous Femoral Stems, Biomet Orthopedics, Inc. (2002) ## Cited in the summary but kept off the family tree - K003315: Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula, Mallinckrodt, Inc. (2000). Our reading of the summary gave K003315, FDA’s number for Shiley Tracheosoft XLT Extended Length Tracheostomy Tube… (Mallinckrodt, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Mallory-Head Modular Calcar Total Hip with Roller-Hardened/Machined…”. Kept off the family tree. Summary page 1. ## Most influential descendants - K042774: Mallory-Head Modular Calcar Stems with Interlocking Slots (2005), 38 descendants of its own - 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 - K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own - K151739: Revision Femoral Stem (2015), 7 descendants of its own ## Recalls of this device - Nov 25, 2020 · Class II · Z-0622-2021: 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. - Mar 10, 2010 · Not classified · Z-1672-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1671-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1679-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1667-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1670-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1673-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1666-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1669-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1665-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1677-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1668-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1676-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1674-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1678-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. - Mar 10, 2010 · Not classified · Z-1675-2010: The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. ## Indications for use Cemented and non-cemented total joint replacement in cases of: 1) Noninflamatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5) Revision of previously failed total hip arthroplasty Source page: https://510kreport.com/device/K031693 Methodology: https://510kreport.com/methodology