510(k) · Cleared
ClearedAvenir Cemented Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Aug 22, 2013 as substantially equivalent to K993043 (Sulzer Orthopedics, Inc., 1999) and 3 other predicates after a 58-day review. Its family tree reaches back 7 generations to 1994. 1 later device descends from it.
- Decided
- Aug 22, 2013
- Review
- 58 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K935452 (1994). 65 ancestors in all, the oldest K845025 (1985). 1 later device descends from it, 1 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 deviceK131884 Avenir Cemented Hip StemZimmer GmbH · 2013
- Descendant · cites it directly · 0 of its ownK182462 Exactech Alteon Highly Polished Femoral StemExactech, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc. · 2018 · 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) | K131884 | Avenir Cemented Hip Stem | Zimmer GmbH | 2013 | — |
| +1 | K182462 | Exactech Alteon Highly Polished Femoral Stem | Exactech, Inc. | 2018 | — |
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 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
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? (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 |
|---|---|---|---|
| * | K993043 | MS-30 Femoral StemSummary page 1…r, cemented or uncemented Classification Panel: Orthopedics/87 Predica te Device(s): MS-30®) Hip Prosthesis, manufactured by Zimmer GmbH, *K993043, cleared December 2, 1999 K01078, cleared June 23, 2000 KO… | 1999 |
| Kept off the family tree | K010078 | FDA’s K010078 is Guthrie Shield Plus Blue Latex Examination Gloves (Powder-Free) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K020713 | MS-30 Lateral Femoral StemSummary page 1…*K993043, cleared December 2, 1999 K01078, cleared June 23, 2000 KO *K0207 13, cleared May 14, 2002 *K040803, cleared April 29, 2004 Page 1/3… | 2002 |
| * | K040803 | MS-30 Femoral Stem Standard and LateralSummary page 1…K01078, cleared June 23, 2000 KO *K0207 13, cleared May 14, 2002 *K040803, cleared April 29, 2004 Page 1/3… | 2004 |
| * | K123392 | Avenir Muller StemSummary page 2…Avenirg® Mflhler Cementless Hip Stem, manufactured by Zimmer GmbH *K123392, cleared March 4, 2013 Purpose and Device The Avenir Cemented Hip Stem is a femoral hip prosthesis Description:… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182462 | Exactech Alteon Highly Polished Femoral Stem | 2018 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 16 of the 65 ancestors have a recall of any class.
- Of its descendants, K182462 (Exactech, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K993043.
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. 2013, 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 product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:
* Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases
* Failed previous hip surgery including joint reconstruction (osteotomy). arthrodesis, hemniarthroplasty 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.
https://510kreport.com/device/K131884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131884: Avenir Cemented Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131884
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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