510(k) · Cleared
ClearedH-Max S stem
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 Aug 22, 2016 as substantially equivalent to K112091 (Lima Corporate S.P.A., 2012) and 2 other predicates after a 231-day review. Its family tree reaches back 12 generations to 1981. 1 of the 233 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Aug 22, 2016
- Review
- 231 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K810258 (1981). 231 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 233 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations between
- 3 generations backK141327 Minima S SystemLima Corporate S.P.A. · 2014
- 2 generations backK143509 MasterSL femoral stemLima Corporate S.P.A. · 2015
- 1 generation backK150855 H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015
- This deviceK160011 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 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 backK141327 Minima S SystemLima Corporate S.P.A. · 2014
- 2 generations backK143509 MasterSL femoral stemLima Corporate S.P.A. · 2015
- 1 generation backK150855 H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015
- This deviceK160011 H-Max S stemLima Corporate S.P.A. · 2016
Class I recalls in this family
- K091423 Profemur Hip System Modular Necks3 generations back · 2009
Most influential descendants
Showing 1 of 1 · See all- K170473C2 femoral stemLima Corporate S.P.A. · 2017 · cites it directly0descendants
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 | K141327 | Minima S System | Lima Corporate S.P.A. | 2014 | — |
| −2 | K143509 | MasterSL femoral stem | Lima Corporate S.P.A. | 2015 | — |
| −1 | K150855 | H-MAX S Femoral Hip System | Lima Corporate S.P.A. | 2015 | — |
| 0 (this device) | 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 | 24 | 0 |
| 1995 | 16 | 0 |
| 1996 | 20 | 0 |
| 1997 | 11 | 0 |
| 1998 | 11 | 0 |
| 1999 | 12 | 0 |
| 2000 | 26 | 0 |
| 2001 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 15 | 0 |
| 2004 | 6 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 1 |
| 2010 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 5…d and neck fractures • Revisions in cases of good remaining femoral bone stock Predicate Devices: • H-MAX S Femoral Hip System – H-MAX S stem (Limacorporate, K112091 and K150855) • POLARSTEM Stabdard and Lateral Femoral Stems with Ti/HA (Smith and Nephew, Inc. K130728) Compa… | 2012 |
| * | K150855 | H-MAX S Femoral Hip SystemSummary page 5…s • Revisions in cases of good remaining femoral bone stock Predicate Devices: • H-MAX S Femoral Hip System – H-MAX S stem (Limacorporate, K112091 and K150855) • POLARSTEM Stabdard and Lateral Femoral Stems with Ti/HA (Smith and Nephew, Inc. K130728) Comparable Features to P… | 2015 |
| * | K130728 | Polarstem Standard and Lateral Femoral Stems with TI/HASummary page 5…moral Hip System – H-MAX S stem (Limacorporate, K112091 and K150855) • POLARSTEM Stabdard and Lateral Femoral Stems with Ti/HA (Smith and Nephew, Inc. K130728) Comparable Features to Predicate Device(s): H-MAX S Stems are exactly the same devices already cleared via K112091 and K150855… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170473 | C2 femoral stem | 2017 | 0 |
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 · 3 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 59 of the 231 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170473 (Lima Corporate S.P.A., 2017) has gone furthest, with 0 descendants 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. 2016, 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 stems are indicated for use in total and partial hip arthroplasty and are intended for press-fit (uncemented) use. The H-Max S Stem are intended for use with CoCrMo femoral heads or Biolox Delta femoral heads and Limacorporate cemented acetabular cups or cementless Delta TT acetabular cups. In partial Hip arthroplasty H-Max S stem is intended for use with Limacorporate Lock Bipolar heads. Hip arthroplasty is intended for reduction or relief…
Read the full statement (118 words)
The H-Max S stems are indicated for use in total and partial hip arthroplasty and are intended for press-fit (uncemented) use. The H-Max S Stem are intended for use with CoCrMo femoral heads or Biolox Delta femoral heads and Limacorporate cemented acetabular cups or cementless Delta TT acetabular cups. In partial Hip arthroplasty H-Max S stem is intended for use with Limacorporate Lock Bipolar heads.
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;
theumatoid arthritis;
treatment of femoral head and neck fractures;
revisions in cases of good remaining femoral bone stock.
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/K160011 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160011: H-Max S stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160011
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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