510(k) Report

510(k) · Cleared

Cleared

Ioi Total Hip

K121034510(k) TraditionalCleared Sep 4, 2012152-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 Sep 4, 2012 as substantially equivalent to K043537 (Biomet, Inc., 2005) and 4 other predicates after a 152-day review. Its family tree reaches back 7 generations to 1985. 11 later devices descend from it.

Decided
Sep 4, 2012
Review
152 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
5

Its longest line of descent runs back 7 generations to K850055 (1985). 90 ancestors in all, the oldest K810258 (1981). 11 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, 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 ancestor2014: 2 descendants cleared2016: 2 descendants cleared2013: 1 descendant cleared2019: 2 descendants cleared2020: 1 descendant cleared2025: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant clearedK850055 · 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 · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 11 other ancestors3 generations back: 18 other ancestors4 generations back: 22 other ancestors5 generations back: 16 other ancestors6 generations back: 10 other ancestors7 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants K110400 · 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 · 7 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
  2. 6 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
  3. 5 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
  4. 4 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
  5. 3 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
  6. 2 generations backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
  7. 1 generation backK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
  8. This deviceK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
  9. Descendant · cites it directly · 8 of its ownK131279 Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
  10. Descendant · cites it directly · 7 of its ownK132572 I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC · 2014
  11. Descendant · cites it directly · 7 of its ownK133228 Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC · 2014
  12. Descendant · cites it directly · 6 of its ownK151307 ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
  13. Descendant · 2 generations on · 2 of its ownK190704 Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd. · 2019

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2013: 12014: 22016: 22019: 22020: 12021: 12024: 12025: 1
2013high 2 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 11 · See all
  • K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013 · cites it directly8descendants
  • K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC · 2014 · cites it directly7descendants
  • K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC · 2014 · cites it directly7descendants
  • K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016 · cites it directly6descendants
  • K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd. · 2019 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K850055Profile Femoral HipDepuy, Inc.1985—
−6K961378Delta Hip ProsthesisZimmer, Inc.19964
−5K992667ZMR Hip System-Revision TaperZimmer, Inc.19991
−4K994286ZMR Hip System-Porous RevisionZimmer, Inc.200011
−3K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.20033
−2K071723Zimmer Porolock Mis StemZimmer GmbH20082
−1K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp2011—
0 (this device)K121034Ioi Total HipIconacy Orthopedic Implants, LLC2012—
+1K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC2013—
+1K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC2014—
+1K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC2014—
+1K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC2016—
+2K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.2019—

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201420
201620
201920
202010
202110
202410
202510
FIG. 1 — Lineage of K121034, 1985–2025Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005—
*K921301Taperloc Femoral Stem and Universal Acetabular Com
Summary page 1
…prosthesis (21 CFR Section 888.3360, Class II) PRODUCT CODES: LPH, LWJ PREDICATE DEVICES: Taperloc Femoral Components (K043S37)(K921 301)(KII10400), Regenerex Ringloc ±+Modular Acetabular Shell (K(070369),…
Biomet, Inc.1994—
*K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp2011—
*K070369Regenerx Ringloc + Modular Acetabular Shells
Summary page 1
…PREDICATE DEVICES: Taperloc Femoral Components (K043S37)(K921 301)(KII10400), Regenerex Ringloc ±+Modular Acetabular Shell (K(070369), ArComiXL Polyethylene Liners (K(042051) DEVICE DESCRIPTION: The ICONACY I-Hip consi…
Biomet, Inc.200719
*K042051Arcomxl Polyethylene Liners
Summary page 1
…21 301)(KII10400), Regenerex Ringloc ±+Modular Acetabular Shell (K(070369), ArComiXL Polyethylene Liners (K(042051) DEVICE DESCRIPTION: The ICONACY I-Hip consists of a collarless, tapered, forged titanium alloy femoral stem, mated…
Biomet, Inc.20051

Also cleared against K043537: 19 other devices →

What descends from it? (11)

See all 11

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138
K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147
K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147
K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166
K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160

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 27 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
  • 20 of the 90 ancestors have a recall of any class.
  • Of its descendants, K131279 (Iconacy Orthopedic Implants, LLC, 2013) has gone furthest, with 8 descendants of its own.
  • 19 other devices also cite its predicate K043537.

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. 2012, 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 system 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, artlirodesis, hemniartliroplasty, surface replacement…

Read the full statement (115 words)

The ICONACY I-Hip system 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, artlirodesis, hemniartliroplasty, surface replacement arthiroplasty, 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-Flip 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.

Also cleared against K043537

19 other devices cite the same predicate.

  • K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc. · 2019
  • K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019
  • K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016
  • K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
  • K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015
  • K141327Minima S SystemLima Corporate S.P.A. · 2014

More from Iconacy Orthopedic Implants, LLC

6 FDA decisions under this applicant name. See the company

  • K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
  • 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

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/K121034 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121034: Ioi Total Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121034

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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