510(k) · Cleared
Recalled · Class II · 2019iTotal® Hip Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conformis, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 14, 2017 as substantially equivalent to K112802 (Pipeline Orthopedics, 2012) and 2 other predicates after a 258-day review. Its family tree reaches back 8 generations to 1994. 17 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 14, 2017
- Review
- 258 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 8 generations to K931641 (1994). 106 ancestors in all, the oldest K810258 (1981). 17 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 7 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 6 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 5 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 4 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 3 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 2 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 1 generation backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- This deviceK162719 iTotal® Hip Replacement SystemConformis, Inc. · 2017
- Descendant · cites it directly · 12 of its ownK192198 Conformis Hip SystemConformis, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 8 of its ownK213389 Identity Imprint Cruciate Retaining (CR) Knee Replacement System and…Conformis, Inc. · 2021
- Descendant · 2 generations on · 7 of its ownK221059 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2022
- Descendant · 3 generations on · 6 of its ownK221404 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2022
- Descendant · cites it directly · 6 of its ownK190904 Conformis BeneFIT Hip SystemConformis, Inc. · 2019 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K192198Conformis Hip SystemConformis, Inc. · 2019 · cites it directly12descendants
- K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc. · 2021 · 2 generations on8descendants
- K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc. · 2022 · 2 generations on7descendants
- K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc. · 2022 · 3 generations on6descendants
- K190904Conformis BeneFIT Hip SystemConformis, Inc. · 2019 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −7 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −6 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −5 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −4 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −3 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −2 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −1 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| 0 (this device) | K162719 | iTotal® Hip Replacement System | Conformis, Inc. | 2017 | — |
| +1 | K192198 | Conformis Hip System | Conformis, Inc. | 2019 | 1 |
| +2 | K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity… | Conformis, Inc. | 2021 | — |
| +2 | K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2022 | — |
| +3 | K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2022 | — |
| +1 | K190904 | Conformis BeneFIT Hip System | Conformis, Inc. | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 7 | 0 |
| 1994 | 15 | 0 |
| 1995 | 6 | 0 |
| 1996 | 12 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 8 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K112802 | Pipeline Total Hip SystemSummary page 5…Product Code: LPH, JDI, OQG, OQH Devices): Regulation Number: 21 CFR 888.3358 510(k) Number: K112802 Corail AMT Hip Prosthesis Device Class: II… | 2012 |
| * | K042992 | Corail Amt Hip ProsthesisSummary page 5…Product Code: LZO Regulation Number: 21 CFR 888.3353 510(k) Number: K042992 Signature Planner, Signature Guides Device Class: II… | 2005 |
| * | K111863 | Signature Planner,Signature GuidesSummary page 5…Code: LPH, LZO, KWZ, JDI, KWY, MAY MEH Regulation Number: 21 CFR 888.3358 510(k) Number: K111863 Identification of the iTotal® CR & PS Knee Replacement Systems Legally Marketed Device Class:… | 2012 |
| † | K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)… | 2016 |
| † | K161668 | ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) | 2016 |
What descends from it? (17)
See all 173 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 |
|---|---|---|---|---|
| Aug 22, 2019 | Class II | Z-0064-2020 | Under Investigation by firm | Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. |
| Aug 22, 2019 | Class II | Z-0063-2020 | Under Investigation by firm | Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. |
| Mar 29, 2019 | Class II | Z-1775-2019 | Device Design | Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants. |
| Oct 16, 2018 | Class II | Z-0731-2019 | Under Investigation by firm | The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 16 of the 106 ancestors have a recall of any class.
- Of its descendants, K192198 (Conformis, Inc., 2019) has gone furthest, with 12 descendants of its own.
- 5 other devices also cite its predicate K112802.
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. 2017, 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 iTotal® Hip Replacement System is designed from a patient’s pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the iTotal® Hip Replacement System is indicated for use in skeletally mature individuals undergoing total hip replacement due to: • A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis…
Read the full statement (147 words)
The iTotal® Hip Replacement System is designed from a patient’s pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the iTotal® Hip Replacement System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
• Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The iTotal® Hip Replacement System includes standard hip replacement components as well as the following patient specific components: femoral neck, acetabular cup, single use instrumentation.
The iTotal® Hip Replacement implants are intended for cementless fixation using an anterior or posterior surgical approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162719: iTotal® Hip Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162719
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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