510(k) · Cleared
ClearedH-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads
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 Nov 9, 2012 as substantially equivalent to K042992 (DePuy Orthopaedics, Inc., 2005) after a 477-day review. Its family tree reaches back 6 generations to 1994. 6 later devices descend from it.
- Decided
- Nov 9, 2012
- Review
- 477 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K935452 (1994). 16 ancestors in all, the oldest K851422 (1985). 6 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 5 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 4 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- 3 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- 2 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- 1 generation backK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- This deviceK112091 H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock…Lima Corporate S.P.A. · 2012
- Descendant · cites it directly · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
- Descendant · 2 generations on · 3 of its ownK143509 MasterSL femoral stemLima Corporate S.P.A. · 2015
- Descendant · cites it directly · 2 of its ownK150855 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 · 2 generations on · 0 of its ownK231925 MINIMA S SystemLima Corporate S.P.A. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141327Minima S SystemLima Corporate S.P.A. · 2014 · cites it directly5descendants
- K143509MasterSL femoral stemLima Corporate S.P.A. · 2015 · 2 generations on3descendants
- K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015 · cites it directly2descendants
- K160011H-Max S stemLima Corporate S.P.A. · 2016 · cites it directly1descendant
- K231925MINIMA S SystemLima Corporate S.P.A. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −5 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −4 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −3 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −2 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| 0 (this device) | K112091 | H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads | Lima Corporate S.P.A. | 2012 | — |
| +1 | 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 | — |
| +1 | K160011 | H-Max S stem | Lima Corporate S.P.A. | 2016 | — |
| +2 | K231925 | MINIMA S System | Lima Corporate S.P.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 MEH? 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? (1)
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 |
|---|---|---|---|
| * | K042992 | Corail Amt Hip ProsthesisSummary page 2…55 Predicate Devices: Corail AMT Femoral stem (Depuy, K042992) Comparable Features to Predicate Device(s): the H-MAX S femoral hip system is similar to the predicate devices in terms of inte… | 2005 |
What descends from it? (6)
4 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 18 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K141327 (Lima Corporate S.P.A., 2014) has gone furthest, with 5 descendants of its own.
- 26 other devices also cite its predicate K042992.
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. 2012, 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 hip arthroplasty and are intended for press-fit (uncemented) use. The H-Max S Stems are intended for use with Co-Cr-Mo femoral heads and Limacorporate standard and protruded cemented cups. The standard and protruded cemented cups are intended for cemented use only.
Hip arthropiasty 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;
treatment of femoral head and neck fractures;
revisions in cases of good remaining fernoral bone stock.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112091 · printed Nov 5, 2026
Cite this page
510(k) Report. “K112091: H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112091
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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