510(k) Report

510(k) · Cleared

Cleared

ICONACY (TM) I-Hip (TM)

K160266510(k) SpecialCleared Apr 8, 201666-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Iconacy Orthopedic Implants, LLC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Apr 8, 2016 as substantially equivalent to K121034 (Iconacy Orthopedic Implants, LLC, 2012) and 1 other predicate after a 66-day review. Its family tree reaches back 9 generations to 1985.

Decided
Apr 8, 2016
Review
66 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
2

Its longest line of descent runs back 9 generations to K850055 (1985). 92 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 2 other ancestors2005: 4 other ancestors1994: 13 other ancestors2011: 1 other ancestor2010: 1 other ancestor2003: 5 other ancestors2002: 4 other ancestors2001: 2 other ancestors1996: 7 other ancestors1983: 1 other ancestor2006: 1 other ancestor2000: 6 other ancestors1999: 4 other ancestors1998: 4 other ancestors1997: 7 other ancestors1995: 6 other ancestors1993: 1 other ancestor1992: 2 other ancestors2004: 2 other ancestors1986: 1 other ancestor1985: 2 other ancestors1981: 1 other ancestor1990: 1 other ancestor1987: 2 other ancestors1988: 2 other ancestors1991: 1 other ancestorK850055 · Profile Femoral Hip · Depuy, Inc. · 1985K961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalled×2: 2 generations cleared close together, K992667 (1999), K994286 (2000) K032726 · Zimmer M/L Taper Hip Prosthesis, 7711 Series · Zimmer, Inc. · 2003 · recalledK071723 · Zimmer Porolock Mis Stem · Zimmer GmbH · 2008 · recalledK110400 · Taperloc Complete Microplasty Stem · Biomet Manufacturing Corp · 2011K121034 · Ioi Total Hip · Iconacy Orthopedic Implants, LLC · 2012K131279 · Iconacy I-Hip System · Iconacy Orthopedic Implants, LLC · 20131980199020002010
Other ancestors, by generation 2 generations back: 4 other ancestors3 generations back: 11 other ancestors4 generations back: 18 other ancestors5 generations back: 22 other ancestors6 generations back: 16 other ancestors7 generations back: 10 other ancestors8 generations back: 2 other ancestors K131279 · Iconacy I-Hip System · Iconacy Orthopedic Implants, LLC · 2013K121034 · Ioi Total Hip · Iconacy Orthopedic Implants, LLC · 2012K110400 · Taperloc Complete Microplasty Stem · Biomet Manufacturing Corp · 2011K071723 · Zimmer Porolock Mis Stem · Zimmer GmbH · 2008 · recalledK032726 · Zimmer M/L Taper Hip Prosthesis, 7711 Series · Zimmer, Inc. · 2003 · recalledK994286 · ZMR Hip System-Porous Revision · Zimmer, Inc. · 2000 · recalledK992667 · ZMR Hip System-Revision Taper · Zimmer, Inc. · 1999 · recalledK961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalledK850055 · Profile Femoral Hip · Depuy, Inc. · 1985−50
  1. Root · 9 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
  2. 5 generations between
  3. 3 generations backK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
  4. 2 generations backK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
  5. 1 generation backK131279 Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
  6. This deviceK160266 ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
Show all 9 generations
  1. Root · 9 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
  2. 8 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
  3. 7 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
  4. 6 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
  5. 5 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
  6. 4 generations backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
  7. 3 generations backK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
  8. 2 generations backK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
  9. 1 generation backK131279 Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
  10. This deviceK160266 ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K850055Profile Femoral HipDepuy, Inc.1985—
−8K961378Delta Hip ProsthesisZimmer, Inc.19964
−7K992667ZMR Hip System-Revision TaperZimmer, Inc.19991
−6K994286ZMR Hip System-Porous RevisionZimmer, Inc.200011
−5K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.20033
−4K071723Zimmer Porolock Mis StemZimmer GmbH20082
−3K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp2011—
−2K121034Ioi Total HipIconacy Orthopedic Implants, LLC2012—
−1K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC2013—
0 (this device)K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198310
198520
198610
198720
198820
199010
199110
199220
199310
1994130
199560
199670
199770
199840
199940
200060
200120
200240
200350
200420
200540
200610
200720
201010
201110
FIG. 1 — Lineage of K160266, 1985–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K121034Ioi Total Hip
Summary page 4
…Panel: Orthopedics Product Code: LPH III. PREDICATE DEVICES ICONACY™ I-Hip™ Total Hip System, K121034 ICONACY™ I-Hip™ Total Hip System, K131279 This predicate has not been subject to a design-relate…
Iconacy Orthopedic Implants, LLC2012—
*K131279Iconacy I-Hip System
Summary page 4
…roduct Code: LPH III. PREDICATE DEVICES ICONACY™ I-Hip™ Total Hip System, K121034 ICONACY™ I-Hip™ Total Hip System, K131279 This predicate has not been subject to a design-related recall. No reference devices were used…
Iconacy Orthopedic Implants, LLC2013—

Also cleared against K121034: 4 other devices →

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 31 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
  • 20 of the 92 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K121034.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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 · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K121034

4 other devices cite the same predicate.

  • K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
  • K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC · 2014
  • K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC · 2014
  • K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013

More from Iconacy Orthopedic Implants, LLC

6 FDA decisions under this applicant name. See the company

  • K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
  • K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC · 2014
  • K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC · 2014
  • K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
  • K121034Ioi Total HipIconacy Orthopedic Implants, LLC · 2012

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K160266 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160266: 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/K160266

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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