510(k) · Cleared
ClearedLibertas Hip Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxx Orthopedics, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Sep 28, 2018 as substantially equivalent to K172857 (Meril Healthcare Pvt., Ltd., 2018) and 9 other predicates after a 168-day review. Its family tree reaches back 13 generations to 1981. 3 later devices descend from it.
- Decided
- Sep 28, 2018
- Review
- 168 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 13 generations to K810258 (1981). 133 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations between
- 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 2 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
- 1 generation backK172857 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2018
- This deviceK180973 Libertas Hip Replacement SystemMaxx Orthopedics, Inc. · 2018
- Descendant · cites it directly · 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 ownK192989 Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK183532 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019
Show all 13 generations
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 7 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 6 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 5 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 4 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 3 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 2 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
- 1 generation backK172857 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2018
- This deviceK180973 Libertas Hip Replacement SystemMaxx Orthopedics, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc. · 2026 · cites it directly0descendants
- K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc. · 2020 · cites it directly0descendants
- K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −12 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −11 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −10 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −9 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −8 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −7 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −6 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −5 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −4 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −3 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −2 | K130343 | Corin Trinity Acetabular System with Extra-Long Heads | Corin USA | 2013 | 2 |
| −1 | K172857 | Latitud Hip Replacement System | Meril Healthcare Pvt., Ltd. | 2018 | — |
| 0 (this device) | K180973 | Libertas Hip Replacement System | Maxx Orthopedics, Inc. | 2018 | — |
| +1 | K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | 2026 | — |
| +1 | K192989 | Libertas E-XLPE Modular Liner | Maxx Orthopedics, Inc. | 2020 | — |
| +1 | 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 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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 |
|---|---|---|---|
| * | K172857 | Latitud Hip Replacement System Cleared while this submission was under review Summary page 5…80973 Predicate Devices Component Predicate Device Manufacturer Submission Number Latitud Hip System Meril K172857 K110087, K103120, Corin’s Trinity… | 2018 |
| * | K110087 | Corin Trinity Acetbular System with Hxlpe LinersSummary page 5…Manufacturer Submission Number Latitud Hip System Meril K172857 K110087, K103120, Corin’s Trinity K130343, K111481: For Acetabular Sys… | 2011 |
| * | K103120 | Corin Biolox Delta Femoral HeadsSummary page 5…urer Submission Number Latitud Hip System Meril K172857 K110087, K103120, Corin’s Trinity K130343, K111481: For Acetabular System… | 2011 |
| * | K130343 | Corin Trinity Acetabular System with Extra-Long HeadsSummary page 5…Meril K172857 K110087, K103120, Corin’s Trinity K130343, K111481: For Acetabular System Shell, HXLPE liner, Includes Mod… | 2013 |
| * | K111481 | Corin Trinity Acetabular System Ecima LinersSummary page 5…K172857 K110087, K103120, Corin’s Trinity K130343, K111481: For Acetabular System Shell, HXLPE liner, Includes Modular shel… | 2012 |
| * | K093472 | Trinity Acetabular SystemSummary page 5…lt- Modular Femoral Head Acetabular Cup Chromium alloy and Corin USA System Biolox® delta Modular K093472: For Bone Femoral Head, Bone screw, Apical Hole Screw, Apical Hol… | 2010 |
| * | K042992 | Corail Amt Hip ProsthesisSummary page 5…reference device DePuy’s Corail® HA DePuy 510(k) Number: Uncemented Coated hip Stem Orthopaedics K042992 femoral stem Latitud Hip System Meril K172857 Stryker’s Exeter® Hip… | 2005 |
| * | K110290 | Exeter Hip StemSummary page 5…Exeter® Hip 510(k) Number: ® Stem (Includes Stryker , K110290: Stem Cemented femoral Cemented stem, Howmedica K933077: Cement stem Cement restrictor and… | 2011 |
| * | K933077 | Exeter Intramedullary Bone PlugSummary page 5…® Stem (Includes Stryker , K110290: Stem Cemented femoral Cemented stem, Howmedica K933077: Cement stem Cement restrictor and Osteonics, USA restrictor Centralizer)… | 1995 |
| * | K974054 | Distal Centralizer, Exeter II Hip SystemSummary page 5…Howmedica K933077: Cement stem Cement restrictor and Osteonics, USA restrictor Centralizer) K974054 : Centralizer Latitud Hip System Meril K172857… | 1997 |
| † | K000306 | Pinnacle Acetabular System | 2000 |
| † | K033273 | Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima… | 2004 |
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)
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 7 companies; a new generation was cleared every 1.4 years on median.
- 35 of the 132 ancestors have a recall of any class.
- Of its descendants, K253171 (Maxx Orthopedics, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172857.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Libertas™ 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 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…
Read the full statement (148 words)
The Libertas™ 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
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 nonunion, femoral neck and trochanteric fractures of the proximal femur.
NOTE:
• The Modular Shell and Uncemented Stem are intended for press-fit, uncemented use only.
• The Cemented stem is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180973: Libertas 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/K180973
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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