510(k) · Cleared
ClearedLatitud Hip Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meril Healthcare Pvt., Ltd. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 19, 2018 as substantially equivalent to K110087 (Corin USA, 2011) and 9 other predicates after a 302-day review. Its family tree reaches back 12 generations to 1981. 5 later devices descend from it.
- Decided
- Jul 19, 2018
- Review
- 302 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 12 generations to K810258 (1981). 131 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations between
- 3 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 2 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 1 generation backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
- This deviceK172857 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2018
- Descendant · cites it directly · 3 of its ownK180973 Libertas Hip Replacement SystemMaxx Orthopedics, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK253171 Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK222436 Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK192989 Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK183532 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019
Show all 12 generations
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 6 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 5 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 4 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 3 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 2 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 1 generation backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
- This deviceK172857 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2018
Most influential descendants
Showing 5 of 5 · See all- K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc. · 2018 · cites it directly3descendants
- K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc. · 2026 · 2 generations on0descendants
- K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2023 · cites it directly0descendants
- K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc. · 2020 · 2 generations on0descendants
- K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −11 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −10 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −9 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −8 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −7 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −6 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −5 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −4 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −3 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −2 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −1 | K130343 | Corin Trinity Acetabular System with Extra-Long Heads | Corin USA | 2013 | 2 |
| 0 (this device) | K172857 | Latitud Hip Replacement System | Meril Healthcare Pvt., Ltd. | 2018 | — |
| +1 | K180973 | Libertas Hip Replacement System | Maxx Orthopedics, Inc. | 2018 | — |
| +2 | K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | 2026 | — |
| +1 | K222436 | Latitud™ Hip Replacement System | Meril Healthcare Pvt., Ltd. | 2023 | — |
| +2 | K192989 | Libertas E-XLPE Modular Liner | Maxx Orthopedics, Inc. | 2020 | — |
| +2 | K183532 | Latitud Hip Replacement System | Meril Healthcare Pvt., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 16 | 0 |
| 1995 | 9 | 0 |
| 1996 | 10 | 0 |
| 1997 | 8 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 12 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 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 24.2 · 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? (10)
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 |
|---|---|---|---|
| * | K110087 | Corin Trinity Acetbular System with Hxlpe LinersSummary page 6…510 k Number: Corin’s Trinity K110087, K103120, Acetabular System K130343… | 2011 |
| * | K103120 | Corin Biolox Delta Femoral HeadsSummary page 6…510 k Number: Corin’s Trinity K110087, K103120, Acetabular System K130343 : For Sh… | 2011 |
| * | K130343 | Corin Trinity Acetabular System with Extra-Long HeadsSummary page 6…K110087, K103120, Acetabular System K130343 : For Shell, (Includes Modular HXLP… | 2013 |
| * | K093472 | Trinity Acetabular SystemSummary page 6…Femoral Head Modular Femoral head, K093472: For Bone Bone screw, Apical screw… | 2010 |
| * | K000306 | Pinnacle Acetabular SystemSummary page 6…DePuy Depuy’s Pinnacle Orthopaedics, 510k Number: K000306 Acetabular System Inc., USA… | 2000 |
| * | K042992 | Corail Amt Hip ProsthesisSummary page 6…510 k Number: Orthopaedics femoral stem Coated hip Stem K042992 France S.A.S… | 2005 |
| * | K110290 | Exeter Hip StemSummary page 6…510 k Number: Stryker’s Exeter® Hip K110290: Stem Stem (Includes Stryker®,… | 2011 |
| * | K980843 | Exeter Intramedullary Bone PlugSummary page 6…K110290: Stem Stem (Includes Stryker®, K980843: Cement Cemented stem, Howmedica Cemented femoral… | 1998 |
| * | K974054 | Distal Centralizer, Exeter II Hip SystemSummary page 6…restrictor Cement restrictor and Osteonics, USA stem K974054, K960258: Centralizer) Centralizer… | 1997 |
| * | K960258 | Natural Hip SystemSummary page 6…restrictor Cement restrictor and Osteonics, USA stem K974054, K960258: Centralizer) Centralizer… | 1996 |
What descends from it? (5)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 34 of the 130 ancestors have a recall of any class.
- Of its descendants, K180973 (Maxx Orthopedics, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 15 other devices also cite its predicate K110087.
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. 2018, 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 Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is an evidence of sufficient sound bone to fix and support the components. Total hip replacement is indicated for the following conditions: • Non-inflammatory degenerative joint diseases including osteoarthritis…
Read the full statement (252 words)
The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is an evidence of sufficient sound bone to fix and support the components.
Total hip replacement is indicated for the following conditions:
• Non-inflammatory degenerative joint diseases including osteoarthritis, post-traumatic arthritis and avascular necrosis.
• Rheumatoid arthritis.
• Congenital hip dysplasia.
• Acute traumatic fracture of the femoral head or neck.
• Certain cases of Ankylosis.
• Dislocation of the hip.
• Correction of functional deformity.
• Revision of failed joint reconstruction or treatment.
• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur.
Note:
• The Titanium coated Modular Acetabular Shell is intended for press-fit, uncemented use only.
• The Hydroxyapatite coated Uncemented Femoral Stem is intended for press-fit, uncemented use only.
• The Cemented Femoral stem is intended for cemented use only.
• The Modular Acetabular Liner is intended for use with Modular Acetabular Shell.
• The CoCr Modular Femoral Head is intended to articulate with Modular Acetabular Liner to mate with uncemented stem or cemented stem.
• The Biolox® delta Modular Femoral Head is intended to articulate with Modular Acetabular Liner and to mate with uncemented stem or cemented stem.
• The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell.
• The Centralizer and Cement Restrictor are intended for use with cemented stem only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172857: Latitud Hip Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172857
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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