510(k) · Cleared
Recalled · Class II · 2025Zimmer Biomet Ceramic Heads
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 Apr 2, 2019 as substantially equivalent to K151307 (Iconacy Orthopedic Implants, LLC, 2016) and 2 other predicates after a 335-day review. Its family tree reaches back 10 generations to 1985. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 2, 2019
- Review
- 335 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 10 generations to K850055 (1985). 107 ancestors in all, the oldest K810258 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 6 generations between
- 3 generations backK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
- 2 generations backK131279 Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
- 1 generation backK151307 ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
- This deviceK181171 Zimmer Biomet Ceramic HeadsZimmer, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025
Show all 10 generations
- Root · 10 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 9 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 8 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- 7 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- 6 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- 5 generations backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- 4 generations backK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
- 3 generations backK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
- 2 generations backK131279 Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
- 1 generation backK151307 ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
- This deviceK181171 Zimmer Biomet Ceramic HeadsZimmer, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −9 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −8 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| −7 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| −6 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| −5 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| −4 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
| −3 | K121034 | Ioi Total Hip | Iconacy Orthopedic Implants, LLC | 2012 | — |
| −2 | K131279 | Iconacy I-Hip System | Iconacy Orthopedic Implants, LLC | 2013 | — |
| −1 | K151307 | ICONACY (TM) I-Hip (TM) | Iconacy Orthopedic Implants, LLC | 2016 | — |
| 0 (this device) | K181171 | Zimmer Biomet Ceramic Heads | Zimmer, Inc. | 2019 | — |
| +1 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020 | 1 |
| +1 | K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 15 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151307 | ICONACY (TM) I-Hip (TM)Summary page 4…semiconstrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353) Primary Predicate: K151307 ICONACY™ ICONACY I-Hip™ Orthopedic… | 2016 |
| * | K071535 | Biolox Delta Ceramic Femoral HeadSummary page 4…I-Hip™ Orthopedic Implants, LLC Additional Predicates: K071535 BIOLOX® delta Zimmer, Inc. Ceramic Femoral… | 2007 |
| * | K131684 | Biolox (R) Delta Ceramic HeadsSummary page 4…Ceramic Femoral Head K131684 BIOLOX® delta Biomet UK Ltd. Ceramic Heads === Page… | 2013 |
| † | K141653 | Biolox Delta Ceramic Option Heads | 2014 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2025 | Class II | Z-1649-2025 | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. |
| Mar 24, 2025 | Class II | Z-1648-2025 | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. |
| Mar 24, 2025 | Class II | Z-1645-2025 | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. |
| Mar 24, 2025 | Class II | Z-1646-2025 | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. |
| Mar 24, 2025 | Class II | Z-1647-2025 | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 24 of the 107 ancestors have a recall of any class.
- Of its descendants, K200823 (Zimmer, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K151307.
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. 2019, 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 Zimmer Biomet™ Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface…
Read the full statement (149 words)
The Zimmer Biomet™ Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
When used with constrained acetabular liners, the Zimmer Biomet™ Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181171: Zimmer Biomet Ceramic Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181171
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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