510(k) · Cleared
ClearedAvenir Complete Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Dec 7, 2018 as substantially equivalent to K123392 (Zimmer GmbH, 2013) and 1 other predicate after a 129-day review. Its family tree reaches back 7 generations to 1994. 5 later devices descend from it.
- Decided
- Dec 7, 2018
- Review
- 129 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K935452 (1994). 61 ancestors in all, the oldest K845025 (1985). 5 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 6 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 5 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 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- 3 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- 2 generations backK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- 1 generation backK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
- This deviceK182048 Avenir Complete Hip SystemZimmer, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK192189 Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK233476 Z1 Hip SystemOrchard Medical Development · 2024 · Recalled
- Descendant · 2 generations on · 1 of its ownK251906 Z1 Hip SystemZimmer, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK260831 Z1 Hip SystemZimmer, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260182 Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc. · 2026
Most influential descendants
Showing 5 of 5 · See all- K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc. · 2019 · cites it directly4descendants
- K233476Z1 Hip SystemOrchard Medical Development · 2024 · cites it directly2descendants
- K251906Z1 Hip SystemZimmer, Inc. · 2025 · 2 generations on1descendant
- K260831Z1 Hip SystemZimmer, Inc. · 2026 · 2 generations on0descendants
- K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −6 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −5 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −4 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −3 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| −1 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
| 0 (this device) | K182048 | Avenir Complete Hip System | Zimmer, Inc. | 2018 | — |
| +1 | K192189 | Avenir Complete Hip System, Size 0 Coxa Vara | Zimmer, Inc. | 2019 | — |
| +1 | K233476 | Z1 Hip System | Orchard Medical Development | 2024 | 1 |
| +2 | K251906 | Z1 Hip System | Zimmer, Inc. | 2025 | — |
| +2 | K260831 | Z1 Hip System | Zimmer, Inc. | 2026 | — |
| +1 | K260182 | Avenir® Müller Stem; Avenir Complete™ Hip System | Zimmer, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 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 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? (2)
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 |
|---|---|---|---|
| * | K123392 | Avenir Muller StemSummary page 4…ed (21 CFR §888.3360). Predicate Device(s): Primary Predicate Device: Avenir® Müller Stem, manufactured by Zimmer GmbH, K123392, cleared March 4, 2013. Additional Predicate Device: Corai… | 2013 |
| * | K042992 | Corail Amt Hip ProsthesisSummary page 4…Additional Predicate Device: Corail AMT™ Hip Prosthesis, manufactured by DePuy Orthopaedics, Inc., K042992, cleared February 11, 2005 .3DJHRI… | 2005 |
What descends from it? (5)
3 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 24 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 14 of the 61 ancestors have a recall of any class.
- Of its descendants, K192189 (Zimmer, Inc., 2019) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K123392.
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. 2018, 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?
Avenir Complete Hip System is intended for total or hemi hip arthroplasty and is indicated for 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.
Avenir Complete Hip System is for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182048 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182048: 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/K182048
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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