510(k) Report

510(k) · Cleared

Cleared

Avenir® Müller Stem; Avenir Complete™ Hip System

K260182510(k) TraditionalCleared Apr 27, 202696-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

Zimmer, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Apr 27, 2026 as substantially equivalent to K193030 (Zimmer GmbH, 2019) and 2 other predicates after a 96-day review. Its family tree reaches back 9 generations to 1994.

Decided
Apr 27, 2026
Review
96 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
3

Its longest line of descent runs back 9 generations to K935452 (1994). 64 ancestors in all, the oldest K845025 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2019: 1 other ancestor2008: 1 other ancestor1996: 8 other ancestors2006: 1 other ancestor2003: 3 other ancestors1994: 7 other ancestors2004: 2 other ancestors2002: 2 other ancestors2000: 6 other ancestors1997: 2 other ancestors1993: 1 other ancestor1985: 3 other ancestors2001: 2 other ancestors1999: 3 other ancestors1998: 2 other ancestors1992: 2 other ancestors1991: 2 other ancestors1990: 1 other ancestor1987: 2 other ancestors1995: 2 other ancestors1988: 2 other ancestorsReference device: K200112 · Zimmer Hip Joint Replacement · Zimmer GmbH · 2020 · recalledK935452 · P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component · Johnson & Johnson Orthopaedics, Inc. · 1994×2: 2 generations cleared close together, K945518 (1996), K961939 (1996) K974331 · Uni-Rom Total Hip System Femoral Stem · Johnson & Johnson Professionals, Inc. · 1998K001991 · Titan Porocoat Hip Prosthesis · DePuy Orthopaedics, Inc. · 2000K042992 · Corail Amt Hip Prosthesis · DePuy Orthopaedics, Inc. · 2005 · recalledK123392 · Avenir Muller Stem · Zimmer GmbH · 2013 · recalledK182048 · Avenir Complete Hip System · Zimmer, Inc. · 2018K192189 · Avenir Complete Hip System, Size 0 Coxa Vara · Zimmer, Inc. · 20191990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 5 other ancestors5 generations back: 11 other ancestors6 generations back: 23 other ancestors7 generations back: 11 other ancestors8 generations back: 2 other ancestors K192189 · Avenir Complete Hip System, Size 0 Coxa Vara · Zimmer, Inc. · 2019K182048 · Avenir Complete Hip System · Zimmer, Inc. · 2018K123392 · Avenir Muller Stem · Zimmer GmbH · 2013 · recalledK042992 · Corail Amt Hip Prosthesis · DePuy Orthopaedics, Inc. · 2005 · recalledK001991 · Titan Porocoat Hip Prosthesis · DePuy Orthopaedics, Inc. · 2000K974331 · Uni-Rom Total Hip System Femoral Stem · Johnson & Johnson Professionals, Inc. · 1998K961939 · S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) · Johnson & Johnson Professionals, Inc. · 1996K945518 · P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component · Johnson & Johnson Professionals, Inc. · 1996K935452 · P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component · Johnson & Johnson Orthopaedics, Inc. · 1994−50
  1. Root · 9 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
  2. 5 generations between
  3. 3 generations backK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
  4. 2 generations backK182048 Avenir Complete Hip SystemZimmer, Inc. · 2018
  5. 1 generation backK192189 Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc. · 2019
  6. This deviceK260182 Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc. · 2026
Show all 9 generations
  1. Root · 9 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
  2. 8 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
  3. 7 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
  4. 6 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
  5. 5 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
  6. 4 generations backK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
  7. 3 generations backK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
  8. 2 generations backK182048 Avenir Complete Hip SystemZimmer, Inc. · 2018
  9. 1 generation backK192189 Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc. · 2019
  10. This deviceK260182 Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K935452P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc.1994—
−8K945518P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc.1996—
−7K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc.1996—
−6K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc.1998—
−5K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc.2000—
−4K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.20051
−3K123392Avenir Muller StemZimmer GmbH20134
−2K182048Avenir Complete Hip SystemZimmer, Inc.2018—
−1K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.2019—
0 (this device)K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198530
198720
198820
199010
199120
199220
199310
199470
199520
199680
199720
199820
199930
200060
200120
200220
200330
200420
200610
200810
201910
FIG. 1 — Lineage of K260182, 1994–2026Source: 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.

Planning a device in LZO? 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K193030Avenir Muller Stem, Avenir Cemented Hip Stem
Summary page 6
…Primary Zimmer Switzerland Avenir® Müller Stem K193030 Predicate Manufacturing GmbH Additional Avenir CompleteTM Hip…
Zimmer GmbH2019—
*K182048Avenir Complete Hip System
Summary page 6
…Manufacturing GmbH Additional Avenir CompleteTM Hip Zimmer, Inc. K182048 Predicate System Avenir CompleteTM Hip Additional…
Zimmer, Inc.2018—
*K192189Avenir Complete Hip System, Size 0 Coxa Vara
Summary page 6
…System Avenir CompleteTM Hip Additional System - Size 0 Coxa Zimmer, Inc. K192189 Predicate Vara Stems Reference Avenir® Müller Stem Zimmer Swit…
Zimmer, Inc.2019—
†K200112Zimmer Hip Joint ReplacementZimmer GmbH20202

Also cleared against K193030: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 32 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
  • 14 of the 64 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K193030.

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. 2026, 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 Avenir Müller Uncemented Hip Stems are intended for cementless use in total or hemi hip arthroplasty and are indicated for the following conditions: • Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis. • Acute traumatic fracture of the femoral head or neck. The Avenir Complete Hip System is intended for cementless use in in total or hemi hip…

Read the full statement (122 words)

The Avenir Müller Uncemented Hip Stems are intended for cementless use in total or hemi hip arthroplasty and are indicated for the following conditions:

• Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis.

• Acute traumatic fracture of the femoral head or neck.

The Avenir Complete Hip System is intended for cementless use in in total or hemi hip arthroplasty and is indicated in the following conditions:

• Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases

• Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR)

• Acute traumatic fracture of the femoral head or neck

• Avascular necrosis of the femoral head

Indications for use as stated in the FDA summary.

Also cleared against K193030

2 other devices cite the same predicate.

  • K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC · 2024
  • K200112Zimmer Hip Joint ReplacementZimmer GmbH · 20202 recalls

More from Zimmer, Inc.

524 FDA decisions under this applicant name. See the company

  • P060037/S100NexGen® LPS-Flex/LPS Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
  • P060037/S099NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • P060037/S098Nexgen LPS Femoral and Tibial Knee componentsZimmer, Inc. · 2026
  • P060037/S097Creep Pressure Test Update for the Nexgen LPS Bearing KneeZimmer, Inc. · 2026

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/K260182 · printed Nov 5, 2026

Cite this page

510(k) Report. “K260182: Avenir® Müller Stem; Avenir Complete™ Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260182

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026