510(k) Report

510(k) · Cleared

Cleared

Minima S System

K141327510(k) TraditionalCleared Aug 6, 201477-day reviewClass II21 CFR 888.3353

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lima Corporate S.P.A. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Aug 6, 2014 as substantially equivalent to K112091 (Lima Corporate S.P.A., 2012) and 9 other predicates after a 77-day review. Its family tree reaches back 9 generations to 1981. 1 of the 183 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.

Decided
Aug 6, 2014
Review
77 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
10

Its longest line of descent runs back 9 generations to K810258 (1981). 177 ancestors in all. 5 later devices descend from it, 3 citing it directly. 1 of the 183 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2013: 2 other ancestors2012: 2 other ancestors2009: 3 other ancestors, 1 with a Class I recall12005: 5 other ancestors1999: 9 other ancestors1998: 10 other ancestors1988: 2 other ancestors2010: 1 other ancestor2008: 1 other ancestor2007: 1 other ancestor2004: 4 other ancestors2003: 14 other ancestors2002: 10 other ancestors2001: 3 other ancestors2000: 18 other ancestors1996: 17 other ancestors1995: 13 other ancestors1994: 19 other ancestors1983: 1 other ancestor2006: 2 other ancestors1997: 11 other ancestors1992: 5 other ancestors1990: 2 other ancestors1991: 3 other ancestors1986: 2 other ancestors1985: 4 other ancestors1993: 2 other ancestors1987: 2 other ancestors2015: 2 descendants cleared2023: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant clearedK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 27 other ancestors, 1 with a Class I recall13 generations back: 38 other ancestors4 generations back: 35 other ancestors5 generations back: 34 other ancestors6 generations back: 22 other ancestors7 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants K100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010K082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−50
  1. Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 5 generations between
  3. 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  4. 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  5. 1 generation backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  6. This deviceK141327 Minima S SystemLima Corporate S.P.A. · 2014
  7. Descendant · cites it directly · 3 of its ownK143509 MasterSL femoral stemLima Corporate S.P.A. · 2015
  8. Descendant · cites it directly · 2 of its ownK150855 H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015
  9. Descendant · 2 generations on · 1 of its ownK160011 H-Max S stemLima Corporate S.P.A. · 2016
  10. Descendant · cites it directly · 0 of its ownK231925 MINIMA S SystemLima Corporate S.P.A. · 2023
  11. Descendant · 2 generations on · 0 of its ownK170473 C2 femoral stemLima Corporate S.P.A. · 2017
Show all 9 generations
  1. Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  8. 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  9. 1 generation backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  10. This deviceK141327 Minima S SystemLima Corporate S.P.A. · 2014

Class I recalls in this family

  • K091423 Profemur Hip System Modular Necks2 generations back · 2009

Most influential descendants

Showing 5 of 5 · See all
  • K143509MasterSL femoral stemLima Corporate S.P.A. · 2015 · cites it directly3descendants
  • K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015 · cites it directly2descendants
  • K160011H-Max S stemLima Corporate S.P.A. · 2016 · 2 generations on1descendant
  • K231925MINIMA S SystemLima Corporate S.P.A. · 2023 · cites it directly0descendants
  • K170473C2 femoral stemLima Corporate S.P.A. · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−8K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−7K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−6K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−5K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−4K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−3K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20073
−2K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…Encore Medical L.P.20081
−1K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010—
0 (this device)K141327Minima S SystemLima Corporate S.P.A.2014—
+1K143509MasterSL femoral stemLima Corporate S.P.A.2015—
+1K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.2015—
+2K160011H-Max S stemLima Corporate S.P.A.2016—
+1K231925MINIMA S SystemLima Corporate S.P.A.2023—
+2K170473C2 femoral stemLima Corporate S.P.A.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198540
198620
198720
198820
199020
199130
199250
199320
1994190
1995130
1996170
1997110
1998100
199990
2000180
200130
2002100
2003140
200440
200550
200620
200710
200810
200931
201010
201220
201320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201610
201710
202310
FIG. 1 — Lineage of K141327, 1981–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K112091H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads
Summary page 5
…al head and neck fractures; x revisions in cases of good remaining femoral bone stock. Predicate Devices: For the Minima S Stem: x H-MAX S stems (Limacorporate, K112091): x Encore Linear Hip (DJO, K972791 and K991325); x Modulus Femoral Hip System (Limacorporate, K112158); x Taperloc 12/1…
Lima Corporate S.P.A.2012—
*K972791Encore Linear Hip
Summary page 5
…sions in cases of good remaining femoral bone stock. Predicate Devices: For the Minima S Stem: x H-MAX S stems (Limacorporate, K112091): x Encore Linear Hip (DJO, K972791 and K991325); x Modulus Femoral Hip System (Limacorporate, K112158); x Taperloc 12/14 Taper Femoral Component (BIOMET, K043…
Encore Orthopedics, Inc.1998—
*K991325Modification of Encore Linear Porous Coated Hip
Summary page 5
…es of good remaining femoral bone stock. Predicate Devices: For the Minima S Stem: x H-MAX S stems (Limacorporate, K112091): x Encore Linear Hip (DJO, K972791 and K991325); x Modulus Femoral Hip System (Limacorporate, K112158); x Taperloc 12/14 Taper Femoral Component (BIOMET, K043537). === P…
Encore Orthopedics, Inc.1999—
*K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads
Summary page 4
…. When used in total hip arthroplasty Minima S stems are coupled to: x Biolox Delta femoral heads (object of this submission) or Limacorporate Femoral Heads (K112158) articulating with Limacorporate Cemented Cups (K112158) or x Biolox Delta heads (object of this submission) or Limacorporat…
Lima Corporate S.P.A.2012—
*K043537Taperloc 12/14 Taper Femoral Components
Summary page 5
…12091): x Encore Linear Hip (DJO, K972791 and K991325); x Modulus Femoral Hip System (Limacorporate, K112158); x Taperloc 12/14 Taper Femoral Component (BIOMET, K043537). K141327 Pg.3/4 For the Biol…
Biomet, Inc.2005—
*K883460Focus Total Hip System
Summary page 6
…K141327 Pg.3/4 For the Biolox Delta Heads: x Femoral Heads (Limacorporate, K112158): x Articul/eze (DJO, K883460 and K980513); x Biolox Delta Ceramic Femoral Heads (Zimmer, K130899); x Biolox Delta Ceramic Femoral Heads (Smith & N…
Depuy, Inc.1988—
*K980513Articul/Eze Femoral Heads
Summary page 6
…K141327 Pg.3/4 For the Biolox Delta Heads: x Femoral Heads (Limacorporate, K112158): x Articul/eze (DJO, K883460 and K980513); x Biolox Delta Ceramic Femoral Heads (Zimmer, K130899); x Biolox Delta Ceramic Femoral Heads (Smith & Nephew, K1004…
DePuy Orthopaedics, Inc.1998—
*K130899Biolox Delta Ceramic Femoral Heads
Summary page 6
…e Biolox Delta Heads: x Femoral Heads (Limacorporate, K112158): x Articul/eze (DJO, K883460 and K980513); x Biolox Delta Ceramic Femoral Heads (Zimmer, K130899); x Biolox Delta Ceramic Femoral Heads (Smith & Nephew, K100412, K083762). Comparable Features to Predicate Device(s): T…
Zimmer GmbH2013—
*K100412Biolox Delta Ceramic Femoral Heads
Summary page 6
…x Articul/eze (DJO, K883460 and K980513); x Biolox Delta Ceramic Femoral Heads (Zimmer, K130899); x Biolox Delta Ceramic Femoral Heads (Smith & Nephew, K100412, K083762). Comparable Features to Predicate Device(s): The Minima S stems are similar to the predicate devices in terms of int…
Smith & Nephew, Inc.2010—
*K083762Biolox Delta Ceramic Femoral Heads
Summary page 6
…rticul/eze (DJO, K883460 and K980513); x Biolox Delta Ceramic Femoral Heads (Zimmer, K130899); x Biolox Delta Ceramic Femoral Heads (Smith & Nephew, K100412, K083762). Comparable Features to Predicate Device(s): The Minima S stems are similar to the predicate devices in terms of intended use…
Smith & Nephew, Inc.2009—

Also cleared against K112091: 3 other devices →

What descends from it? (5)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K143509MasterSL femoral stemLima Corporate S.P.A.20153
K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152
K231925MINIMA S SystemLima Corporate S.P.A.20230

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 33 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
  • 44 of the 177 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.
  • 3 other devices also cite its predicate K112091.

How does its category compare?

All LZO devices

LZO 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

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

What is it indicated for?

The Minima S System is indicated for use in partial or total hip arthroplasty and is intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Minima S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the Minima S 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…

Read the full statement (116 words)

The Minima S System is indicated for use in partial or total hip arthroplasty and is intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Minima S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the Minima S 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:

x non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis

and hip dysplasia;

x rheumatoid arthritis;

x treatment of femoral head and neck fractures;

x revisions in cases of good remaining femoral bone stock.

Indications for use as stated in the FDA summary.

Also cleared against K112091

3 other devices cite the same predicate.

  • K170473C2 femoral stemLima Corporate S.P.A. · 2017
  • K160011H-Max S stemLima Corporate S.P.A. · 2016
  • K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015

More from Lima Corporate S.P.A.

64 FDA decisions under this applicant name. See the company

  • K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A. · 2026
  • K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A. · 2025
  • K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025
  • K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025
  • K243615Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K141327 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141327: Minima S System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141327

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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