510(k) · Cleared
ClearedMastersl Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jun 10, 2014 as substantially equivalent to K972791 (Encore Orthopedics, Inc., 1998) and 3 other predicates after a 55-day review. Its family tree reaches back 8 generations to 1994. 1 of the 97 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Jun 10, 2014
- Review
- 55 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K921308 (1994). 92 ancestors in all, the oldest K830313 (1983). 4 later devices descend from it, 1 citing it directly. 1 of the 97 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 7 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 6 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 5 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 4 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- 3 generations backK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
- 2 generations backK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
- 1 generation backK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- This deviceK140975 Mastersl Femoral StemLima Corporate S.P.A. · 2014
- Descendant · cites it directly · 3 of its ownK143509 MasterSL femoral stemLima Corporate S.P.A. · 2015
- Descendant · 2 generations on · 2 of its ownK150855 H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015
- Descendant · 3 generations on · 1 of its ownK160011 H-Max S stemLima Corporate S.P.A. · 2016
- Descendant · 3 generations on · 0 of its ownK170473 C2 femoral stemLima Corporate S.P.A. · 2017
Class I recalls in this family
- K091423 Profemur Hip System Modular Necks2 generations back · 2009
Most influential descendants
Showing 4 of 4 · See all- K143509MasterSL femoral stemLima Corporate S.P.A. · 2015 · cites it directly3descendants
- K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015 · 2 generations on2descendants
- K160011H-Max S stemLima Corporate S.P.A. · 2016 · 3 generations on1descendant
- K170473C2 femoral stemLima Corporate S.P.A. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −7 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −6 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −5 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −4 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| −3 | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | 18 |
| −2 | K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200… | Encore Medical L.P. | 2010 | 1 |
| −1 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| 0 (this device) | K140975 | Mastersl Femoral Stem | Lima Corporate S.P.A. | 2014 | — |
| +1 | K143509 | MasterSL femoral stem | Lima Corporate S.P.A. | 2015 | — |
| +2 | K150855 | H-MAX S Femoral Hip System | Lima Corporate S.P.A. | 2015 | — |
| +3 | K160011 | H-Max S stem | Lima Corporate S.P.A. | 2016 | — |
| +3 | 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 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 11 | 0 |
| 1995 | 10 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 10 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K120091 | FDA’s K120091 is R&D Innovation Pedicle Screw System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2012 |
| * | K972791 | Encore Linear HipSummary page 2…fractures; " revisions in eases of good remaining femoral bone stock. Predicate Devices: * H-MAX S stems (Limacorporate, KI 12091): * Encore Linear Hip (DJO, K972791 and K99 1325); * Modulus Femoral Hip System (Limacorporate, K1 12158); * Taperloc 12/14 Taper Femoral Component (BIOMET, K(… | 1998 |
| * | K991325 | Modification of Encore Linear Porous Coated HipSummary page 2…" revisions in eases of good remaining femoral bone stock. Predicate Devices: * H-MAX S stems (Limacorporate, KI 12091): * Encore Linear Hip (DJO, K972791 and K99 1325); * Modulus Femoral Hip System (Limacorporate, K1 12158); * Taperloc 12/14 Taper Femoral Component (BIOMET, K(043537). Com… | 1999 |
| * | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsSummary page 2…ck. Predicate Devices: * H-MAX S stems (Limacorporate, KI 12091): * Encore Linear Hip (DJO, K972791 and K99 1325); * Modulus Femoral Hip System (Limacorporate, K1 12158); * Taperloc 12/14 Taper Femoral Component (BIOMET, K(043537). Comparable Features to Predicate Device(s): The MasterS stems… | 2012 |
| * | K043537 | Taperloc 12/14 Taper Femoral ComponentsSummary page 2…1): * Encore Linear Hip (DJO, K972791 and K99 1325); * Modulus Femoral Hip System (Limacorporate, K1 12158); * Taperloc 12/14 Taper Femoral Component (BIOMET, K(043537). Comparable Features to Predicate Device(s): The MasterS stems are substantially equivalent to the predicate devices in terms… | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143509 | MasterSL femoral stem | 2015 | 3 |
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 20 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 25 of the 92 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K143509 (Lima Corporate S.P.A., 2015) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K972791.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The MasterSL stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Master SL Stems are intended for use with Ca-Cr-Mo femnoral heads and cemented cups or with Co-Cr-Mo, femoral heads and Delta TI' Acetabular System. When used in partial hip arthraplasty, the MasterSL stems are intended for use with Lock Bipolar Heads. Hip arthroplasty is intended for…
Read the full statement (124 words)
The MasterSL stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Master SL Stems are intended for use with Ca-Cr-Mo femnoral heads and cemented cups or with Co-Cr-Mo, femoral heads and Delta TI' Acetabular System. When used in partial hip arthraplasty, the MasterSL stems are intended for use with 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;
* rheumatoid arthritis;
* treatment of femoral head and neck fractures;
* revisions in cases of good remaining femoral bone stock.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140975 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140975: Mastersl Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140975
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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