510(k) · Cleared
Recalled · Class II · 2024Smith & Nephew Hip Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 1, 2022 as substantially equivalent to K052792 (Smith & Nephew, Inc., 2005) and 66 other predicates after a 437-day review. Its family tree reaches back 9 generations to 1981. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 1, 2022
- Review
- 437 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 67
Its longest line of descent runs back 9 generations to K810258 (1981). 177 ancestors in all, the oldest K791125 (1979). 3 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 1 generation backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- This deviceK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular…Smith & Nephew, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK242375 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK231448 TANDEM Hip SystemSmith & Nephew, Inc. · 2023 · Recalled
Show all 9 generations
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 1 generation backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- This deviceK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc. · 2024 · cites it directly0descendants
- K242375OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024 · cites it directly0descendants
- K231448TANDEM Hip SystemSmith & Nephew, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −8 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −7 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −6 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −5 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −4 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −3 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −2 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −1 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| 0 (this device) | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | — |
| +1 | K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners… | Smith & Nephew, Inc. | 2024 | — |
| +1 | K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2024 | — |
| +1 | K231448 | TANDEM Hip System | Smith & Nephew, Inc. | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 3 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 3 | 0 |
| 1992 | 6 | 0 |
| 1993 | 3 | 0 |
| 1994 | 15 | 0 |
| 1995 | 6 | 0 |
| 1996 | 12 | 0 |
| 1997 | 11 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 2 | 0 |
| 2002 | 11 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (67)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052792 | Anthology Hip StemSummary page 31…facturer Description Number Date Smith & Nephew, K052792 10/07/2005 Anthology Hip System Inc. Smith & Nephew,… | 2005 |
| * | K171934 | Birmingham Hip (BH) Dual Mobility InsertSummary page 31…K052792 10/07/2005 Anthology Hip System Inc. Smith & Nephew, K171934 11/30/2017 BH Dual Mobility System Inc. Smith & Nephew,… | 2017 |
| * | K962541 | Reflection Acetabular Reinforcement RingsSummary page 31…K171934 11/30/2017 BH Dual Mobility System Inc. Smith & Nephew, K962541 09/17/1996 Contour Acetabular System K040680 06/14/2004 Inc. Smith & N… | 1996 |
| * | K040680 | Contour HA Coated Reconstruction RingSummary page 31…obility System Inc. Smith & Nephew, K962541 09/17/1996 Contour Acetabular System K040680 06/14/2004 Inc. Smith & Nephew, K970351 02/28/1997… | 2004 |
| * | K970351 | Global Taper Spectron Hip StemsSummary page 31…09/17/1996 Contour Acetabular System K040680 06/14/2004 Inc. Smith & Nephew, K970351 02/28/1997 CPCS Cemented Hip System K823727 03/08/1983 Inc.… | 1997 |
| * | K823727 | Spectron Primary Stem Femoral ProsthesSummary page 31…06/14/2004 Inc. Smith & Nephew, K970351 02/28/1997 CPCS Cemented Hip System K823727 03/08/1983 Inc. K983834 02/24/1999 Smith & N… | 1983 |
| * | K983834 | Echelon Hip StemSummary page 31…02/28/1997 CPCS Cemented Hip System K823727 03/08/1983 Inc. K983834 02/24/1999 Smith & Nephew, K023302 10/25/2002… | 1999 |
| * | K023302 | Echelon Porous Plus HA Hip StemsSummary page 31…03/08/1983 Inc. K983834 02/24/1999 Smith & Nephew, K023302 10/25/2002 Echelon Hip System Inc. K96348… | 2002 |
| * | K963486 | Revision Hip SystemSummary page 31…K023302 10/25/2002 Echelon Hip System Inc. K963486 11/27/1996 K021673 06/11/2002… | 1996 |
| * | K021673 | Total Hip Femoral Head - 12/14 TaperSummary page 31…Echelon Hip System Inc. K963486 11/27/1996 K021673 06/11/2002 K022902 10/02/2002… | 2002 |
| * | K022902 | Smith & Nephew Hip SystemSummary page 31…11/27/1996 K021673 06/11/2002 K022902 10/02/2002 K022958 10/02/2002… | 2002 |
| * | K022958 | Total Hip Femoral Heads and LinersSummary page 31…3 06/11/2002 K022902 10/02/2002 K022958 10/02/2002 K072817 05/15/2008… | 2002 |
| * | K072817 | Echelon Titanium Hip SystemSummary page 31…2 10/02/2002 K022958 10/02/2002 K072817 05/15/2008 K083762 03/11/2009 Smith & Nephew,… | 2008 |
| * | K083762 | Biolox Delta Ceramic Femoral HeadsSummary page 31…8 10/02/2002 K072817 05/15/2008 K083762 03/11/2009 Smith & Nephew, K093363 01/26/2010… | 2009 |
| * | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSummary page 31…7 05/15/2008 K083762 03/11/2009 Smith & Nephew, K093363 01/26/2010 Femoral Heads K100412 05/05/2010 Inc.… | 2010 |
| * | K100412 | Biolox Delta Ceramic Femoral HeadsSummary page 31…2 03/11/2009 Smith & Nephew, K093363 01/26/2010 Femoral Heads K100412 05/05/2010 Inc. K110101 04/11/2011… | 2010 |
| * | K110101 | Taper Oxinium Femoral HeadSummary page 31…01/26/2010 Femoral Heads K100412 05/05/2010 Inc. K110101 04/11/2011 K914878 07/30/1992… | 2011 |
| * | K914878 | Zirconium Alloy Frmoral HeadSummary page 31…05/05/2010 Inc. K110101 04/11/2011 K914878 07/30/1992 K963509 01/27/1997… | 1992 |
| * | K963509 | Global Taper Tapered Hip System, GT SpectronSummary page 31…1 04/11/2011 K914878 07/30/1992 K963509 01/27/1997 K971414 07/16/1997 Smith & Nephew,… | 1997 |
| * | K971414 | Zirconia Prozyr Ceramic 12/14 Global Taper (GT) Femoral HeadsSummary page 31…8 07/30/1992 K963509 01/27/1997 K971414 07/16/1997 Smith & Nephew, K093991 04/15/2010… | 1997 |
| * | K093991 | SLR-Plus Standard and Lateral Femoral StemsSummary page 31…01/27/1997 K971414 07/16/1997 Smith & Nephew, K093991 04/15/2010 HI Cup Inc. Page 8 of 10 === Page 32… | 2010 |
| * | K921400 | Hip Joint ProthesisSummary page 32…/2010 HI Cup Inc. Page 8 of 10 Smith & Nephew, K921400 04/02/1993 Modular Hip Stems K900628 05/09/1990 Inc.… | 1993 |
| * | K900628 | Modular Hip SystemSummary page 32…Page 8 of 10 Smith & Nephew, K921400 04/02/1993 Modular Hip Stems K900628 05/09/1990 Inc. K070278 04/16/2007 Smith & Nephew,… | 1990 |
| * | K070278 | Polarcup Dual Mobility SystemSummary page 32…K921400 04/02/1993 Modular Hip Stems K900628 05/09/1990 Inc. K070278 04/16/2007 Smith & Nephew, K110135 10/14/2011 POLARCUP Inc.… | 2007 |
| * | K110135 | Polarcup Dual Mobility SystemSummary page 32…ms K900628 05/09/1990 Inc. K070278 04/16/2007 Smith & Nephew, K110135 10/14/2011 POLARCUP Inc. K122244 08/23/2012 Smith & Nephew,… | 2011 |
| * | K122244 | Polarcup Dual Mobility SystemSummary page 32…0278 04/16/2007 Smith & Nephew, K110135 10/14/2011 POLARCUP Inc. K122244 08/23/2012 Smith & Nephew, K130728 10/10/2013 POLARSTEM… | 2012 |
| * | K130728 | Polarstem Standard and Lateral Femoral Stems with TI/HASummary page 32…135 10/14/2011 POLARCUP Inc. K122244 08/23/2012 Smith & Nephew, K130728 10/10/2013 POLARSTEM K143739 04/20/2015 Inc.… | 2013 |
| * | K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASummary page 32…K122244 08/23/2012 Smith & Nephew, K130728 10/10/2013 POLARSTEM K143739 04/20/2015 Inc. K070756 06/06/2007… | 2015 |
| * | K070756 | Smith and Nephew Reflection 3 Acetabular SystemSummary page 32…K130728 10/10/2013 POLARSTEM K143739 04/20/2015 Inc. K070756 06/06/2007 K083566 03/03/2009… | 2007 |
| * | K083566 | R3 Constrained Liner, Constrained LinerSummary page 32…K143739 04/20/2015 Inc. K070756 06/06/2007 K083566 03/03/2009 K092386 11/03/2009… | 2009 |
| * | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSummary page 32…K070756 06/06/2007 K083566 03/03/2009 K092386 11/03/2009 K093363 01/26/2010 Smith & Nephew,… | 2009 |
| * | K102370 | R3 Xlpe Anteverted LinersSummary page 32…K092386 11/03/2009 K093363 01/26/2010 Smith & Nephew, K102370 01/19/2011 R3 Acetabular System Inc. K113848 04/27/2012… | 2011 |
| * | K113848 | R3 Xlpe LinersSummary page 32…/2010 Smith & Nephew, K102370 01/19/2011 R3 Acetabular System Inc. K113848 04/27/2012 K182535 11/19/2018… | 2012 |
| * | K182535 | R3 Anteverted LinersSummary page 32…/2011 R3 Acetabular System Inc. K113848 04/27/2012 K182535 11/19/2018 K081124 07/31/2008… | 2018 |
| * | K081124 | MDF Revision Hip SystemSummary page 32…K113848 04/27/2012 K182535 11/19/2018 K081124 07/31/2008 K100481 07/15/2010 Smith & Nephew, Redapt Monoblock Revision… | 2008 |
| * | K100481 | Smith & Nephew MDF Modular SleeveSummary page 32…K182535 11/19/2018 K081124 07/31/2008 K100481 07/15/2010 Smith & Nephew, Redapt Monoblock Revision K121627 10/15/2012 Inc. Femoral System… | 2010 |
| * | K121627 | Smith & Nephew Redapt Revision Femoral SystemSummary page 32…K081124 07/31/2008 K100481 07/15/2010 Smith & Nephew, Redapt Monoblock Revision K121627 10/15/2012 Inc. Femoral System K151902 09/03/2015… | 2012 |
| * | K151902 | REDAPT¿ Revision Femoral SystemSummary page 32…K100481 07/15/2010 Smith & Nephew, Redapt Monoblock Revision K121627 10/15/2012 Inc. Femoral System K151902 09/03/2015 K162303 05/01/2017… | 2015 |
| * | K162303 | REDAPT Sleeved Monolithic Revision StemsSummary page 32…oblock Revision K121627 10/15/2012 Inc. Femoral System K151902 09/03/2015 K162303 05/01/2017 K150790 11/16/2015 Smith & Nephew, Redapt Revision Acetabul… | 2017 |
| * | K150790 | REDAPT Porous Acetabular Shell and Cemented LinerSummary page 32…tem K151902 09/03/2015 K162303 05/01/2017 K150790 11/16/2015 Smith & Nephew, Redapt Revision Acetabular K160923 11/17/2016 Inc. System… | 2015 |
| * | K160923 | REDAPT Anteverted Cemented LinerSummary page 32…K162303 05/01/2017 K150790 11/16/2015 Smith & Nephew, Redapt Revision Acetabular K160923 11/17/2016 Inc. System K171073 11/21/2017… | 2016 |
| * | K171073 | Smith & Nephew, Inc. REDAPT AugmentsSummary page 32…K150790 11/16/2015 Smith & Nephew, Redapt Revision Acetabular K160923 11/17/2016 Inc. System K171073 11/21/2017 K182109 11/16/2018… | 2017 |
| * | K182109 | REDAPT Modular Acetabular ShellSummary page 32…ision Acetabular K160923 11/17/2016 Inc. System K171073 11/21/2017 K182109 11/16/2018 K002747 12/15/2000… | 2018 |
| * | K002747 | Reflection Cross-Linked Uhmwpe Acetabular ComponentsSummary page 32…K171073 11/21/2017 K182109 11/16/2018 K002747 12/15/2000 K021803 12/19/2002… | 2000 |
| * | K021803 | Reflection Constrained LinerSummary page 32…K182109 11/16/2018 K002747 12/15/2000 K021803 12/19/2002 K022556 08/28/2002… | 2002 |
| * | K022556 | Reflection Modified Acetabular ShellsSummary page 32…K002747 12/15/2000 K021803 12/19/2002 K022556 08/28/2002 K022902 10/02/2002… | 2002 |
| * | K033442 | Reflection Constrained LinerSummary page 32…K022556 08/28/2002 K022902 10/02/2002 K033442 11/26/2003 Smith & Nephew, Reflection Acetabular System - K071160 10/05… | 2003 |
| * | K071160 | Reflection, Tandem UnipolarSummary page 32…K033442 11/26/2003 Smith & Nephew, Reflection Acetabular System - K071160 10/05/2007 Inc. Metal Shell K920430 07/21/1992… | 2007 |
| * | K920430 | Modular Acetabular Cup SystemSummary page 32…bular System - K071160 10/05/2007 Inc. Metal Shell K920430 07/21/1992 K932755 05/06/1994… | 1992 |
| * | K932755 | Reflection Acetabular ComponentSummary page 32…0 10/05/2007 Inc. Metal Shell K920430 07/21/1992 K932755 05/06/1994 K990666 08/06/1999… | 1994 |
| * | K990666 | Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit…Summary page 32…K920430 07/21/1992 K932755 05/06/1994 K990666 08/06/1999 K960094 03/27/1996 Smith & Nephew,… | 1999 |
| * | K960094 | Reflection Dual Dimension ShellSummary page 32…K932755 05/06/1994 K990666 08/06/1999 K960094 03/27/1996 Smith & Nephew, K002747 12/15/2000 Reflection All-Poly Cup… | 1996 |
| * | K103256 | Smith & Nephew SMF Hip StemSummary page 32…ith & Nephew, K002747 12/15/2000 Reflection All-Poly Cup Inc. Smith & Nephew, Short Monoblock Femoral (SMF) K103256 01/31/2011 Inc. Hip System K123012 10/24/2012… | 2011 |
| * | K123012 | Smith & Nephew SMF Hip StemSummary page 32…Reflection All-Poly Cup Inc. Smith & Nephew, Short Monoblock Femoral (SMF) K103256 01/31/2011 Inc. Hip System K123012 10/24/2012 K072852 06/09/2008 Smith & Nephew, SL-Plus and SLR-Plus Cem… | 2012 |
| * | K072852 | SL-Plus Standard and Lateral Hip StemsSummary page 32…lock Femoral (SMF) K103256 01/31/2011 Inc. Hip System K123012 10/24/2012 K072852 06/09/2008 Smith & Nephew, SL-Plus and SLR-Plus Cementless K093991 04/15/2010 Inc. Femoral Hip System… | 2008 |
| * | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSummary page 32…K072852 06/09/2008 Smith & Nephew, SL-Plus and SLR-Plus Cementless K093991 04/15/2010 Inc. Femoral Hip System K120211 07/19/2012 K122296 08/28/2012 Page 9… | 2012 |
| * | K122296 | SL-Plus Mia Femoral Stems with TI/HA CoatingSummary page 32…d SLR-Plus Cementless K093991 04/15/2010 Inc. Femoral Hip System K120211 07/19/2012 K122296 08/28/2012 Page 9 of 10… | 2012 |
| * | K823723 | Spectron Proximal Femoral ProsthesisSummary page 33…K122296 08/28/2012 Page 9 of 10 K823723 03/09/1983 Smith & Nephew, K831884 09/20/1983… | 1983 |
| * | K831884 | Spectron Extra-Small, Straight FemoralSummary page 33…10 K823723 03/09/1983 Smith & Nephew, K831884 09/20/1983 Spectron EF Hip System Inc. K… | 1983 |
| * | K791125 | Plug-Lok Cement RestirctorSummary page 33…ctron EF Hip System Inc. K970351 02/28/1997 K791125 06/27/1979 K002996 12/11/2000… | 1979 |
| * | K002996 | Synergy HA Coated Porous Femoral StemsSummary page 33…02/28/1997 K791125 06/27/1979 K002996 12/11/2000 K963509 01/27/1997 Smith & Nephew,… | 2000 |
| * | K970337 | HA Global Taper (GT) Tapered Hip StemSummary page 33…12/11/2000 K963509 01/27/1997 Smith & Nephew, K970337 02/28/1997 Synergy Hip System Inc. K9903… | 1997 |
| * | K990369 | Synergy Cemented Hip StemSummary page 33…K970337 02/28/1997 Synergy Hip System Inc. K990369 03/12/1999 K991485 07/12/1999… | 1999 |
| * | K991485 | Synergy Porous Size 8 Hip StemSummary page 33…Synergy Hip System Inc. K990369 03/12/1999 K991485 07/12/1999 K023743 01/23/2003 Smith & Nephew… | 1999 |
| * | K023743 | Smith & Nephew Global Bipolar SystemSummary page 33…03/12/1999 K991485 07/12/1999 K023743 01/23/2003 Smith & Nephew, Tandem Bipolar/Unipolar Hip K896580 02/15/1990 Inc.… | 2003 |
| * | K896580 | Uni-Polar HeadSummary page 33…07/12/1999 K023743 01/23/2003 Smith & Nephew, Tandem Bipolar/Unipolar Hip K896580 02/15/1990 Inc. System K934353 04/25/1994 Conclusion… | 1990 |
| * | K934353 | Zirconium Alloy Uni-Polar HeadSummary page 33…01/23/2003 Smith & Nephew, Tandem Bipolar/Unipolar Hip K896580 02/15/1990 Inc. System K934353 04/25/1994 Conclusion In summary, the only differences between the subject devices and the commercially… | 1994 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2024 | Class II | Z-0326-2025 | Under Investigation by firm | The Bipolar assembly contains an oversized Retainer Ring. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 41 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 43 of the 176 ancestors have a recall of any class.
- Of its descendants, K240783 (Smith & Nephew, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 18 other devices also cite its predicate K052792.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The components are indicated for the following: 1. Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; 2. Rheumatoid arthritis; 3. Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; 4. Revision procedures where other treatment or devices have failed; and 5. Treatment…
Read the full statement (1,886 words)
The components are indicated for the following:
1. Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis;
2. Rheumatoid arthritis;
3. Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
4. Revision procedures where other treatment or devices have failed; and
5. Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The components are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
1. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
2. Fracture or avascular necrosis of the femoral head
3. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
The POLARSTEM with Ti/HA is intended for single use only and is to be implanted without bone cement.
1. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
2. Fracture or avascular necrosis of the femoral head
3. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
4. All forms of osteoarthritis
5. Patients with hips at risk of dislocation
6. Femoral neck fracture or proximal fracture to hip joint
The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement> The POLARCUP Dual Mobility System is intended for single use only.
The indications for use in total hip arthoplasty include rheumatoid arthritis; osteoarthritis; post-traumatic arthritis; avascular necrosis and femoral neck fractures.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised.
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211176 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211176: Smith & Nephew Hip Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211176
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026