510(k) · Cleared
ClearedIconacy I-Hip System, Gradual Transitioning (GT) Femoral System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iconacy Orthopedic Implants, LLC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jan 17, 2014 as substantially equivalent to K121034 (Iconacy Orthopedic Implants, LLC, 2012) after an 88-day review. Its family tree reaches back 8 generations to 1985. 7 later devices descend from it.
- Decided
- Jan 17, 2014
- Review
- 88 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K850055 (1985). 91 ancestors in all, the oldest K810258 (1981). 7 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 7 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 6 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- 5 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- 4 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- 3 generations backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- 2 generations backK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
- 1 generation backK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
- This deviceK133228 Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC · 2014
- Descendant · cites it directly · 6 of its ownK151307 ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK190704 Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd. · 2019
- Descendant · 2 generations on · 2 of its ownK181171 Zimmer Biomet Ceramic HeadsZimmer, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 0 of its ownK250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016 · cites it directly6descendants
- K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd. · 2019 · 2 generations on2descendants
- K181171Zimmer Biomet Ceramic HeadsZimmer, Inc. · 2019 · 2 generations on2descendants
- K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · 3 generations on1descendant
- K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −7 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −6 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| −5 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| −4 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| −3 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| −2 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
| −1 | K121034 | Ioi Total Hip | Iconacy Orthopedic Implants, LLC | 2012 | — |
| 0 (this device) | K133228 | Iconacy I-Hip System, Gradual Transitioning (GT) Femoral System | Iconacy Orthopedic Implants, LLC | 2014 | — |
| +1 | K151307 | ICONACY (TM) I-Hip (TM) | Iconacy Orthopedic Implants, LLC | 2016 | — |
| +2 | K190704 | Signature Ceramic Femoral Head | Signature Orthopaedics Pty, Ltd. | 2019 | — |
| +2 | K181171 | Zimmer Biomet Ceramic Heads | Zimmer, Inc. | 2019 | 5 |
| +3 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020 | 1 |
| +3 | 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 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 13 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K121034 | Ioi Total HipSummary page 1…ection 888.3358, Class 11) PRODUCT CODES: I-PH, LWJ PREDICATE DEVICE: ICONACY I-Hip Total Hip System, 1K121034 DEVICE DESCRIPTION: The ICONACY I-I-lip System consists of a collarless, tapered, forged titanium alloy femoral stem mated to… | 2012 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151307 | ICONACY (TM) I-Hip (TM) | 2016 | 6 |
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 29 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 20 of the 91 ancestors have a recall of any class.
- Of its descendants, K151307 (Iconacy Orthopedic Implants, LLC, 2016) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K121034.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The ICONACY I-Hip System is indicated for the following conditions: (1) a severely painfu 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, hemidarrhroplasty, surface replacement…
Read the full statement (114 words)
The ICONACY I-Hip System is indicated for the following conditions: (1) a severely painfu 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, hemidarrhroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and crochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The ICONACY 1-Hip System 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/K133228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133228: Iconacy I-Hip System, Gradual Transitioning (GT) Femoral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133228
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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