510(k) Report

510(k) · Cleared

Cleared

C2 femoral stem

K170473510(k) TraditionalCleared Nov 8, 2017265-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 Nov 8, 2017 as substantially equivalent to K112091 (Lima Corporate S.P.A., 2012) and 8 other predicates after a 265-day review. Its family tree reaches back 13 generations to 1981. 1 of the 237 devices in its family, counting itself, has a Class I recall.

Decided
Nov 8, 2017
Review
265 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
9

Its longest line of descent runs back 13 generations to K810258 (1981). 236 ancestors in all. No later device cites it as a predicate yet. 1 of the 237 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2015: 1 other ancestor2012: 5 other ancestors2008: 2 other ancestors2003: 16 other ancestors1996: 20 other ancestors2014: 2 other ancestors2013: 3 other ancestors2005: 8 other ancestors2002: 12 other ancestors2000: 26 other ancestors1994: 24 other ancestors1987: 2 other ancestors2010: 2 other ancestors2009: 5 other ancestors, 1 with a Class I recall12007: 3 other ancestors2004: 6 other ancestors1999: 12 other ancestors1998: 11 other ancestors1995: 16 other ancestors1988: 2 other ancestors1985: 6 other ancestors2001: 7 other ancestors1997: 11 other ancestors1992: 5 other ancestors1990: 2 other ancestors1983: 1 other ancestor2006: 2 other ancestors1993: 5 other ancestors1986: 3 other ancestors1991: 3 other ancestorsReference device: K112158 · Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads · Lima Corporate S.P.A. · 2012Reference device: K141934 · Physica KR Knee System · Lima Corporate S.P.A. · 2015Reference device: K100858 · Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies, · Lima-Lto S.P.A. · 2010 · recalledReference device: K151739 · Revision Femoral Stem · Lima Corporate S.P.A. · 2015K810258 · 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. · 2010K141327 · Minima S System · Lima Corporate S.P.A. · 2014K143509 · MasterSL femoral stem · Lima Corporate S.P.A. · 2015K150855 · H-MAX S Femoral Hip System · Lima Corporate S.P.A. · 2015K160011 · H-Max S stem · Lima Corporate S.P.A. · 20161980199020002010
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 10 other ancestors3 generations back: 37 other ancestors, 1 with a Class I recall14 generations back: 41 other ancestors5 generations back: 43 other ancestors6 generations back: 47 other ancestors7 generations back: 24 other ancestors8 generations back: 11 other ancestors9 generations back: 3 other ancestors K160011 · H-Max S stem · Lima Corporate S.P.A. · 2016K150855 · H-MAX S Femoral Hip System · Lima Corporate S.P.A. · 2015K143509 · MasterSL femoral stem · Lima Corporate S.P.A. · 2015K141327 · Minima S System · Lima Corporate S.P.A. · 2014K100412 · 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. · 1981−10−50
  1. Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 9 generations between
  3. 3 generations backK143509 MasterSL femoral stemLima Corporate S.P.A. · 2015
  4. 2 generations backK150855 H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015
  5. 1 generation backK160011 H-Max S stemLima Corporate S.P.A. · 2016
  6. This deviceK170473 C2 femoral stemLima Corporate S.P.A. · 2017
Show all 13 generations
  1. Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 7 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  8. 6 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  9. 5 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  10. 4 generations backK141327 Minima S SystemLima Corporate S.P.A. · 2014
  11. 3 generations backK143509 MasterSL femoral stemLima Corporate S.P.A. · 2015
  12. 2 generations backK150855 H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015
  13. 1 generation backK160011 H-Max S stemLima Corporate S.P.A. · 2016
  14. This deviceK170473 C2 femoral stemLima Corporate S.P.A. · 2017

Class I recalls in this family

  • K091423 Profemur Hip System Modular Necks3 generations back · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−12K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−11K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−10K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−9K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−8K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−7K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20073
−6K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…Encore Medical L.P.20081
−5K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010—
−4K141327Minima S SystemLima Corporate S.P.A.2014—
−3K143509MasterSL femoral stemLima Corporate S.P.A.2015—
−2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.2015—
−1K160011H-Max S stemLima Corporate S.P.A.2016—
0 (this device)K170473C2 femoral stemLima Corporate S.P.A.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198560
198630
198720
198820
199020
199130
199250
199350
1994240
1995160
1996200
1997110
1998110
1999120
2000260
200170
2002120
2003160
200460
200580
200620
200730
200820
200951
201020
201250
201330
201420
201510
FIG. 1 — Lineage of K170473, 1981–2017Source: 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? (9)

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
…hritis; • revisions in cases of good remaining femoral bone stock. • treatment of femoral head and neck fractures. Predicate Devices: • H-MAX S stem (Limacorporate, K112091 - K150855 - K160011). • Alloclassic Zweymüller Stem stems (Zimmer, K962101, K030373, K033664); • SL-PLUS stem (Smith&Nephew…
Lima Corporate S.P.A.2012—
*K150855H-MAX S Femoral Hip System
Summary page 5
…revisions in cases of good remaining femoral bone stock. • treatment of femoral head and neck fractures. Predicate Devices: • H-MAX S stem (Limacorporate, K112091 - K150855 - K160011). • Alloclassic Zweymüller Stem stems (Zimmer, K962101, K030373, K033664); • SL-PLUS stem (Smith&Nephew, K072852,…
Lima Corporate S.P.A.2015—
*K160011H-Max S stem
Summary page 5
…in cases of good remaining femoral bone stock. • treatment of femoral head and neck fractures. Predicate Devices: • H-MAX S stem (Limacorporate, K112091 - K150855 - K160011). • Alloclassic Zweymüller Stem stems (Zimmer, K962101, K030373, K033664); • SL-PLUS stem (Smith&Nephew, K072852, K120211,…
Lima Corporate S.P.A.2016—
*K962101Zweymueller SL Femoral Hip Stem
Summary page 5
…of femoral head and neck fractures. Predicate Devices: • H-MAX S stem (Limacorporate, K112091 - K150855 - K160011). • Alloclassic Zweymüller Stem stems (Zimmer, K962101, K030373, K033664); • SL-PLUS stem (Smith&Nephew, K072852, K120211, K143096); Reference Devices: • Modulus stem (Limacorp…
Intermedics Orthopedics1996—
*K030373Alloclassic Zweymueller SL/SLL Femoral Stem
Summary page 5
…al head and neck fractures. Predicate Devices: • H-MAX S stem (Limacorporate, K112091 - K150855 - K160011). • Alloclassic Zweymüller Stem stems (Zimmer, K962101, K030373, K033664); • SL-PLUS stem (Smith&Nephew, K072852, K120211, K143096); Reference Devices: • Modulus stem (Limacorporate, K1…
Centerpulse Orthopedics, Inc.20031
*K033664Modification to Alloclassic Zweymuller SL Offset Femoral Stem
Summary page 5
…nd neck fractures. Predicate Devices: • H-MAX S stem (Limacorporate, K112091 - K150855 - K160011). • Alloclassic Zweymüller Stem stems (Zimmer, K962101, K030373, K033664); • SL-PLUS stem (Smith&Nephew, K072852, K120211, K143096); Reference Devices: • Modulus stem (Limacorporate, K112158). •…
Centerpulse Orthopedics, Inc.20031
*K072852SL-Plus Standard and Lateral Hip Stems
Summary page 5
…H-MAX S stem (Limacorporate, K112091 - K150855 - K160011). • Alloclassic Zweymüller Stem stems (Zimmer, K962101, K030373, K033664); • SL-PLUS stem (Smith&Nephew, K072852, K120211, K143096); Reference Devices: • Modulus stem (Limacorporate, K112158). • Tibial winged broach (Limacorporate, K1…
Smith & Nephew, Inc.2008—
*K120211SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating
Summary page 5
…stem (Limacorporate, K112091 - K150855 - K160011). • Alloclassic Zweymüller Stem stems (Zimmer, K962101, K030373, K033664); • SL-PLUS stem (Smith&Nephew, K072852, K120211, K143096); Reference Devices: • Modulus stem (Limacorporate, K112158). • Tibial winged broach (Limacorporate, K141934). •…
Smith & Nephew, Inc.2012—
*K143096SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
Summary page 5
…macorporate, K112091 - K150855 - K160011). • Alloclassic Zweymüller Stem stems (Zimmer, K962101, K030373, K033664); • SL-PLUS stem (Smith&Nephew, K072852, K120211, K143096); Reference Devices: • Modulus stem (Limacorporate, K112158). • Tibial winged broach (Limacorporate, K141934). • H-MAX…
Smith & Nephew, Inc.2015—
†K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.2012—
†K141934Physica KR Knee SystemLima Corporate S.P.A.2015—
†K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A.20102
†K151739Revision Femoral StemLima Corporate S.P.A.2015—

Also cleared against K112091: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 36 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
  • 60 of the 236 ancestors have a recall of any class; 1 has a Class I recall.
  • 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. 2017, 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?

Monolithic cementless stems are indicated for use in partial or total hip arthroplasty and they are intended for press-fit (uncemented) use. When used in total hip arthroplasty, monolithic cementless stems are intended for use with modular heads and compatible acetabular cups. When used in partial hip arthroplasty, they are intended for use with bipolar heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in…

Read the full statement (109 words)

Monolithic cementless stems are indicated for use in partial or total hip arthroplasty and they are intended for press-fit (uncemented) use.

When used in total hip arthroplasty, monolithic cementless stems are intended for use with modular heads and compatible acetabular cups.

When used in partial hip arthroplasty, they are intended for use with 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 including osteoarthritis, avascular necrosis and dysplasia;

* theumatoid arthritis;

* revisions in cases of good remaining femoral bone stock;

* treatment of femoral head and neck fractures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K112091

3 other devices cite the same predicate.

  • K160011H-Max S stemLima Corporate S.P.A. · 2016
  • K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015
  • K141327Minima S SystemLima Corporate S.P.A. · 2014

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/K170473 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170473: C2 femoral stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170473

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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