510(k) · Cleared
ClearedICONACY (TM) I-Hip (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iconacy Orthopedic Implants, LLC · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Feb 26, 2016 as substantially equivalent to K071535 (Zimmer, Inc., 2007) and 4 other predicates after a 284-day review. Its family tree reaches back 9 generations to 1985. 6 later devices descend from it.
- Decided
- Feb 26, 2016
- Review
- 284 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K850055 (1985). 105 ancestors in all, the oldest K810258 (1981). 6 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 5 generations between
- 3 generations backK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
- 2 generations backK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
- 1 generation backK131279 Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
- This deviceK151307 ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
- Descendant · cites it directly · 2 of its ownK190704 Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK181171 Zimmer Biomet Ceramic HeadsZimmer, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025
- Descendant · 2 generations on · 0 of its ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 8 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 7 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- 6 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- 5 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- 4 generations backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- 3 generations backK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
- 2 generations backK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
- 1 generation backK131279 Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
- This deviceK151307 ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd. · 2019 · cites it directly2descendants
- K181171Zimmer Biomet Ceramic HeadsZimmer, Inc. · 2019 · cites it directly2descendants
- K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · 2 generations on1descendant
- K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025 · 2 generations on0descendants
- K240452Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −8 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −7 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| −6 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| −5 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| −4 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| −3 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
| −2 | K121034 | Ioi Total Hip | Iconacy Orthopedic Implants, LLC | 2012 | — |
| −1 | K131279 | Iconacy I-Hip System | Iconacy Orthopedic Implants, LLC | 2013 | — |
| 0 (this device) | K151307 | ICONACY (TM) I-Hip (TM) | Iconacy Orthopedic Implants, LLC | 2016 | — |
| +1 | K190704 | Signature Ceramic Femoral Head | Signature Orthopaedics Pty, Ltd. | 2019 | — |
| +1 | K181171 | Zimmer Biomet Ceramic Heads | Zimmer, Inc. | 2019 | 5 |
| +2 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020 | 1 |
| +2 | K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025 | — |
| +2 | K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024 | — |
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 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071535 | Biolox Delta Ceramic Femoral HeadSummary page 4…888.3353, Class II) PRODUCT CODE: LZO PREDICATE DEVICES: Zimmer Biolox delta Ceramic Femoral Head, K071535 ICONACY I-Hip Total Hip System, K121034 ICONACY I-Hip Total Hip Sys… | 2007 |
| * | K121034 | Ioi Total HipSummary page 4…LZO PREDICATE DEVICES: Zimmer Biolox delta Ceramic Femoral Head, K071535 ICONACY I-Hip Total Hip System, K121034 ICONACY I-Hip Total Hip System (RS Acetabular Cups and Rings), K131… | 2012 |
| * | K131279 | Iconacy I-Hip SystemSummary page 4…ICONACY I-Hip Total Hip System, K121034 ICONACY I-Hip Total Hip System (RS Acetabular Cups and Rings), K131279 ICONACY I-Hip Total Hip System (Gradual Transitioning Femoral Stems… | 2013 |
| * | K133228 | Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemSummary page 4…Rings), K131279 ICONACY I-Hip Total Hip System (Gradual Transitioning Femoral Stems), K133228 ICONACY I-Hip Total Hip System (Additional Acetabular Liners, Apex… | 2014 |
| * | K132572 | I-Hip Total Hip SystemSummary page 4…Femoral Stems), K133228 ICONACY I-Hip Total Hip System (Additional Acetabular Liners, Apex Hole Plug), K132572 DEVICE DESCRIPTION: The ICONACY I-Hip consists of a collarless, tapered, forged titanium alloy femoral stem mated to a modular… | 2014 |
What descends from it? (6)
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)
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 31 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 23 of the 105 ancestors have a recall of any class.
- Of its descendants, K190704 (Signature Orthopaedics Pty, Ltd., 2019) has gone furthest, with 2 descendants of its own.
- 14 other devices also cite its predicate K071535.
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. 2016, 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 ICONACY I-Hip is 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…
Read the full statement (113 words)
The ICONACY I-Hip is 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.
The ICONACY I-Hip consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151307: ICONACY (TM) I-Hip (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151307
Report an extraction error
Are you the manufacturer?
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