510(k) · Cleared
ClearedH-MAX S Femoral Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Oct 21, 2015 as substantially equivalent to K112091 (Lima Corporate S.P.A., 2012) and 5 other predicates after a 204-day review. Its family tree reaches back 11 generations to 1981. 1 of the 226 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Oct 21, 2015
- Review
- 204 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K810258 (1981). 223 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 226 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 2 generations backK141327 Minima S SystemLima Corporate S.P.A. · 2014
- 1 generation backK143509 MasterSL femoral stemLima Corporate S.P.A. · 2015
- This deviceK150855 H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015
- Descendant · cites it directly · 1 of its ownK160011 H-Max S stemLima Corporate S.P.A. · 2016
- Descendant · cites it directly · 0 of its ownK170473 C2 femoral stemLima Corporate S.P.A. · 2017
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 4 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 3 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 2 generations backK141327 Minima S SystemLima Corporate S.P.A. · 2014
- 1 generation backK143509 MasterSL femoral stemLima Corporate S.P.A. · 2015
- This deviceK150855 H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015
Class I recalls in this family
- K091423 Profemur Hip System Modular Necks2 generations back · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −4 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −3 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −2 | K141327 | Minima S System | Lima Corporate S.P.A. | 2014 | — |
| −1 | K143509 | MasterSL femoral stem | Lima Corporate S.P.A. | 2015 | — |
| 0 (this device) | K150855 | H-MAX S Femoral Hip System | Lima Corporate S.P.A. | 2015 | — |
| +1 | K160011 | H-Max S stem | Lima Corporate S.P.A. | 2016 | — |
| +1 | K170473 | C2 femoral stem | Lima Corporate S.P.A. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 6 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 23 | 0 |
| 1995 | 16 | 0 |
| 1996 | 20 | 0 |
| 1997 | 11 | 0 |
| 1998 | 11 | 0 |
| 1999 | 12 | 0 |
| 2000 | 25 | 0 |
| 2001 | 7 | 0 |
| 2002 | 11 | 0 |
| 2003 | 15 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 1 |
| 2010 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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.
1 device in this family has a Class I recall. 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K112091 | H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsSummary page 6…abular socket needs reconstruction. The Limacorporate Delta TT Cup is intended for uncemented use. Predicate Devices • H-MAX S Femoral Hip System (Limacorporate, K112091) • Minima S System (Limacorporate, K141327) • Master SL Femoral Stem (Limacorporate, K143509) • Modulus Femoral… | 2012 |
| * | K141327 | Minima S SystemSummary page 6…rate Delta TT Cup is intended for uncemented use. Predicate Devices • H-MAX S Femoral Hip System (Limacorporate, K112091) • Minima S System (Limacorporate, K141327) • Master SL Femoral Stem (Limacorporate, K143509) • Modulus Femoral Stem (Limacorporate, K112158) • Delta TT A… | 2014 |
| * | K143509 | MasterSL femoral stemSummary page 6…cate Devices • H-MAX S Femoral Hip System (Limacorporate, K112091) • Minima S System (Limacorporate, K141327) • Master SL Femoral Stem (Limacorporate, K143509) • Modulus Femoral Stem (Limacorporate, K112158) • Delta TT Acetabular System (Limacorporate, K112898, K141395). Co… | 2015 |
| * | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsSummary page 6…corporate, K112091) • Minima S System (Limacorporate, K141327) • Master SL Femoral Stem (Limacorporate, K143509) • Modulus Femoral Stem (Limacorporate, K112158) • Delta TT Acetabular System (Limacorporate, K112898, K141395). Comparable Features to Predicate Device(s) The subject… | 2012 |
| * | K112898 | Delta TT Cups, Delta TT Liners, Bone ScrewsSummary page 6…K141327) • Master SL Femoral Stem (Limacorporate, K143509) • Modulus Femoral Stem (Limacorporate, K112158) • Delta TT Acetabular System (Limacorporate, K112898, K141395). Comparable Features to Predicate Device(s) The subject H-MAX S Femoral Hip Stems are identical to the H-MAX S Femor… | 2012 |
| * | K141395 | Delta TT Acetabular SystemSummary page 6…• Master SL Femoral Stem (Limacorporate, K143509) • Modulus Femoral Stem (Limacorporate, K112158) • Delta TT Acetabular System (Limacorporate, K112898, K141395). Comparable Features to Predicate Device(s) The subject H-MAX S Femoral Hip Stems are identical to the H-MAX S Femoral Hip St… | 2014 |
| † | K140975 | Mastersl Femoral Stem | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 57 of the 223 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K160011 (Lima Corporate S.P.A., 2016) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K112091.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The H-MAX S Femoral Hip System consists of the H-MAX S femoral stem, a modular femoral head, and an acetabular cup. In total hip arthroplasty, the H-Max S Stems are intended for use with modular CoCrMo femoral heads or Biolox Delta ceramic femoral heads and a compatible Limacorporate Cemented Cup or uncemented Delta TT acetabular cup. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients…
Read the full statement (134 words)
The H-MAX S Femoral Hip System consists of the H-MAX S femoral stem, a modular femoral head, and an acetabular cup. In total hip arthroplasty, the H-Max S Stems are intended for use with modular CoCrMo femoral heads or Biolox Delta ceramic femoral heads and a compatible Limacorporate Cemented Cup or uncemented Delta TT acetabular cup.
Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia; rheumatoid arthritis; osteoarthritis after femoral heads fractures; revisions in cases of good remaining femoral bone stock.
The Limacorporate Cemented Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs reconstruction. The Limacorporate Delta TT Cup is intended for uncemented use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150855: H-MAX S Femoral Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150855
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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