510(k) · Cleared
ClearedZ1 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 Jun 16, 2026 as substantially equivalent to K251906 (Zimmer, Inc., 2025) and 1 other predicate after a 95-day review. Its family tree reaches back 11 generations to 1994.
- Decided
- Jun 16, 2026
- Review
- 95 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K935452 (1994). 65 ancestors in all, the oldest K845025 (1985). No later device cites it as a predicate yet.
- Root · 11 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 7 generations between
- 3 generations backK192189 Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc. · 2019
- 2 generations backK233476 Z1 Hip SystemOrchard Medical Development · 2024 · Recalled
- 1 generation backK251906 Z1 Hip SystemZimmer, Inc. · 2025
- This deviceK260831 Z1 Hip SystemZimmer, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 10 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 9 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- 8 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- 7 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- 6 generations backK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- 5 generations backK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
- 4 generations backK182048 Avenir Complete Hip SystemZimmer, Inc. · 2018
- 3 generations backK192189 Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc. · 2019
- 2 generations backK233476 Z1 Hip SystemOrchard Medical Development · 2024 · Recalled
- 1 generation backK251906 Z1 Hip SystemZimmer, Inc. · 2025
- This deviceK260831 Z1 Hip SystemZimmer, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −10 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −9 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −8 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −7 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| −5 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
| −4 | K182048 | Avenir Complete Hip System | Zimmer, Inc. | 2018 | — |
| −3 | K192189 | Avenir Complete Hip System, Size 0 Coxa Vara | Zimmer, Inc. | 2019 | — |
| −2 | K233476 | Z1 Hip System | Orchard Medical Development | 2024 | 1 |
| −1 | K251906 | Z1 Hip System | Zimmer, Inc. | 2025 | — |
| 0 (this device) | K260831 | Z1 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 |
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 |
|---|---|---|---|
| * | K251906 | Z1 Hip SystemSummary page 5…LWJ – Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR 888.3360) Predicate Device Primary Predicate: K251906, Z1 Hip System Additional Predicate: K233476, Z1 Hip System Device The Z1 Hip System consists of f… | 2025 |
| * | K233476 | Z1 Hip SystemSummary page 5…ented or uncemented prosthesis (21 CFR 888.3360) Predicate Device Primary Predicate: K251906, Z1 Hip System Additional Predicate: K233476, Z1 Hip System Device The Z1 Hip System consists of femoral hip stems intended for use in total or hemi hip Descripti… | 2024 |
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 6 companies; a new generation was cleared every 1.5 years on median.
- 15 of the 65 ancestors have a recall of any class.
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. 2026, 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?
Z1 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260831: Z1 Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260831
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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