# K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional - Pathway: 510(k) (Traditional) - Applicant: Depuy Ireland UC - Decided: Jan 19, 2024 after 207 days - Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate) - Device class: 2 - Regulation: 21 CFR 888.3353 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 18 generations back to K941847 (1994). 286 ancestors in all. 5 later devices descend from it; 3 cite it directly. 0 of 291 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K102080: Depuy Reclaim Revision Hip System, Depuy (Ireland) (2010) Summary page 8. - K982918: Depuy C-Stem System, DePuy Orthopaedics, Inc. (1998) Summary page 7. - K013350: Modification to Depuy C-Stem System, DePuy Orthopaedics, Inc. (2001) Summary page 7. - K042959: Depuy C-Stem Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2004) Summary page 7. - K082239: Depuy C-Stem Amt, DePuy Orthopaedics, Inc. (2008) Summary page 7. - K220216: C-Stem AMT LE Prosthesis, Depuy Ireland UC (2022) Summary page 7. - K093736: Depuy Corail Hip System, Revision Stem, DePuy Orthopaedics, Inc. (2011) Summary page 7. - K851422: S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip, Joint Medical Products Corp. (1985) Summary page 7. - K910664: Mod. Trochanter Screw & Washer W/ Anodized Titan., Medimix Products, Inc. (1992) Summary page 7. - K934412: Coated ZT Proximal Sleeve, Joint Medical Products Corp. (1994) Summary page 7. - K961939: S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115), Johnson & Johnson Professionals, Inc. (1996) Summary page 7. - K073570: Depuy Tri-Lock Bone Preservation Stem, DePuy Orthopaedics, Inc. (2008) Summary page 7. - K211657: EMPHASYS Femoral Stems, Depuy Ireland UC (2021) Summary page 10. - K942370: Depuy Cemented Hip Prosthesis, Depuy, Inc. (1994) Summary page 6. - K961619: Depuy Endurance Calcar Hip Prosthesis, Depuy, Inc. (1996) Summary page 6. - K903084: Modular Cathcart Fracture System, Depuy, Inc. (1990) Summary page 7. - K221462: DePuy Reclaim Monobloc Revision Femoral Stem, Depuy Ireland UC (2022) Summary page 8. - K953703: Depuy Vision Solution Hip Prosthesis, Depuy, Inc. (1996) Summary page 9. - K030979: Modification to Depuy Solution System Hip Prosthesis, DePuy Orthopaedics, Inc. (2003) Summary page 9. - K060581: Depuy Solution System Hip Prosthesis, DePuy Orthopaedics, Inc. (2006) Summary page 9. - K001991: Titan Porocoat Hip Prosthesis, DePuy Orthopaedics, Inc. (2000) Summary page 10. - K011489: Summit Duofix Hip Prosthesis, DePuy Orthopaedics, Inc. (2001) Summary page 10. - K013352: Summit Cemented Hip Prosthesis, DePuy Orthopaedics, Inc. (2001) Summary page 10. - K023453: Depuy Summit FX Cemented Hip Prosthesis, DePuy Orthopaedics, Inc. (2002) Summary page 10. - K030122: Depuy Summit Basic Press-Fit Hip Stem, DePuy Orthopaedics, Inc. (2003) Summary page 10. - K202472: ACTIS Duofix Hip Prosthesis, DePuy Orthopaedics, Inc. (2020) Summary page 10. - K210581: Actis DuoFix Hip Prosthesis- Collarless, Depuy Ireland UC (2021) Summary page 10. - K192946: DePuy Corail AMT Hip Prosthesis, DePuy Orthopaedics, Inc. (2019) Summary page 10. - K200854: DePuy PINNACLE Dual Mobility Liner, Depuy Ireland UC (2020) Summary page 13. - K203532: BI-MENTUM™ ALTRX® Dual Mobility Liner, Depuy Ireland UC (2021) Summary page 12. - K072963: Depuy Pinnacle Altrx Acetabular Liners, DePuy Orthopaedics, Inc. (2008) Summary page 14. - K102423: Depuy Pinnacle Altrx Acetabular Liners, DePuy Orthopaedics, Inc. (2010) Summary page 14. - K132959: Depuy Pinnacle Altrx Acetabular Liners, DePuy Orthopaedics, Inc. (2014) Summary page 14. - K090998: Depuy Pinnacle 100 with Gription Acetabular Cups, DePuy Orthopaedics, Inc. (2009) Summary page 14. - K093646: Depuy Pinnacle with Gription Acetabular Cups, DePuy Orthopaedics, Inc. (2009) Summary page 14. - K033273: Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima Unipolar Femoral Heads, DePuy Orthopaedics, Inc. (2004) Summary page 14. - K001534: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 14. - K033338: Pinnacle Revision System, DePuy Orthopaedics, Inc. (2004) Summary page 15. - K192919: Pinnacle Duofix HA Acetabular Cup Prosthesis, DePuy Orthopaedics, Inc. (2019) Summary page 15. - K040544: Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062 and 1599-21-044 to -062, Depuy, Inc. (2004) Summary page 15. - K951674: Depuy Duraloc 100C Acetabular Cup, Depuy, Inc. (1995) Summary page 15. - K961186: Depuy Duraloc Cementless Acetabular Cup System, Depuy, Inc. (1996) Summary page 15. - K994415: Marathon Cross-Linked Polyethylene Acetabular Cup Liners, DePuy Orthopaedics, Inc. (2000) Summary page 15. - K010171: Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene Liner, DePuy Orthopaedics, Inc. (2001) Summary page 15. - K863184: Profile Hip Acetabulum Prosthesis, Depuy, Inc. (1987) Summary page 15. - K221636: EMPHASYS Acetabular System, Depuy Ireland UC (2022) Summary page 15. - K011533: Depuy Femoral Heads, DePuy Orthopaedics, Inc. (2002) Summary page 17. - K031803: Depuy Ceramic Femoral Heads, DePuy Orthopaedics, Inc. (2003) Summary page 17. - K062748: Modification: to Depuy Delta Ceramic Femoral Head, DePuy Orthopaedics, Inc. (2006) Summary page 17. - K071830: Depuy Delta TS Ceramic Femoral Heads, DePuy Orthopaedics, Inc. (2007) Summary page 17. - K871867: Elite Modular Hip System, Thackray USA (1988) Summary page 17. - K812672: Self-Centering Hip, Depuy, Inc. (1981) Summary page 18. - K860701: HPS II Smooth Stem, Depuy, Inc. (1986) Summary page 17. - K880269: LCS Femoral Hip Prosthesis, Depuy, Inc. (1988) Summary page 17. - K883460: Focus Total Hip System, Depuy, Inc. (1988) Summary page 17. - K060031: Depuy Modular M Heads, DePuy Orthopaedics, Inc. (2006) Summary page 17. - K980513: Articul/Eze Femoral Heads, DePuy Orthopaedics, Inc. (1998) Summary page 17. - K120599: Depuy M-Spec 36MM Femoral Heads, Depuy Orthopaedics (2013) Summary page 17. - K222296: ARTICUL/EZE Ceramic Heads, Depuy Ireland UC (2023) Summary page 17. - K920317: S-Rom LF Femoral Head, Joint Medical Products Corp. (1992) Summary page 19. - K861979: Aml II Titanium Acetabulum Prosthesis, Depuy, Inc. (1987) Summary page 21. - K970929: Depuy Low Profile Bone Screw, Depuy, Inc. (1997) Summary page 21. - K983014: Summit Acetabular System, Johnson & Johnson Professionals, Inc. (1998) Summary page 21. - K123924: Depuy Gription TF 5.5MM Sterile Locking Screws, Depuy Orthopaedics (2013) Summary page 21. - K100391: Depuy Universal Gription TF Cones, DePuy Orthopaedics, Inc. (2010) Summary page 25. - K800894: Dupuy Cement Restrictor Trials & Instr., Depuy, Inc. (1980) Summary page 27. - K871510: Modified Profile Hip Pmma Cement Spacer, Depuy, Inc. (1987) Summary page 28. - K963309: Apex Hole Eliminator PS, Depuy, Inc. (1996) Summary page 23. - K971682: J-FX Cerclage System, Johnson & Johnson Professionals, Inc. (1997) Summary page 24. - K963206: S-Rom Hip System - Locking Plug, Johnson & Johnson Professionals, Inc. (1996) Summary page 29. - K951000: ZTT I and II Acetabular Cup of the S-Rom Total Hip System, Joint Medical Products Corp. (1995) Summary page 29. ## Most influential descendants - K251292: RECLAIM Monobloc Revision Femoral Stem (2025), 1 descendant of its own - K243977: EMPHASYS Acetabular System (2025), 1 descendant of its own - K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own - K252067: Velora Acetabular System (2025), 0 descendants of its own - K242084: EMPHASYS Acetabular Shell with RapiTite HA (2024), 0 descendants of its own ## Indications for use Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The DePuy® C-Stem AMT Hip Stem is indicated for cemented use only. HA-coated stems of the CORAIL Hip System are indicated for cementless use only. The DePuy RECLAIM Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The Solution Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Hemi hip replacement is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Total hip replacement or hip arthroplasty is indicated in the following conditions: 1. A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease). 2. Failed previous hip surgery. 3. Dislocation risks. PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE Acetabular Cups are intended for cementless applications. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. INDICATIONS — TOTAL HIP PROSTHESIS Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Certain cases of ankylosis. INDICATIONS — HEMI-HIP PROSTHESIS Hemi-hip arthroplasty is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. The DePuy Screws are indicated for use in primary or revision hip surgery for total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The Apex Hole Eliminator PS is a threaded plug intended to close the apical hole of the Duraloc series two-piece (metal shell and UHMWPe liner) acetabular cups. It is intended for use in Duraloc cups implanted with or without bone cement. The J-Fx Cerclage System is indicated for use as a cerclage fixation device in general orthopaedic repairs. These include procedures such as: reinforcement of bone; reattachment of the greater trochanter; fixation of long bone fractures with grafting; and fixation of patellar fractures. The DePuy Gription TF Acetabular Augments, Buttresses and Shims are indicated for use in total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The porous Gription TF titanium acetabular augment is affixed to the mating acetabular cup using bone cement or mechanical screw fixation. The assembled porous titanium augment is intended for cemented or cementless use. The porous Gription TF titanium shim is affixed to the mating buttress using bone cement. This porous Gription TF titanium buttress is affixed to the mating acetabular cup using bone cement. The assembled buttress/acetabular cup construct is intended for cemented or cementless use. The UHMWPe cement restrictor is intended for use in cemented total and hemiarthroplasty procedures to restrict distal flow of bone cement in the femoral medullary cavity. The Modified Profile Hip PMMA Spacer is indicated for use in cemented hip replacement. Total hip arthroplasty is indicated for total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Source page: https://510kreport.com/device/K231873 Methodology: https://510kreport.com/methodology