510(k) · Cleared
Recalled · Class II · 2020Conformis Hip 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 Nov 6, 2019 as substantially equivalent to K162719 (Conformis, Inc., 2017) after an 85-day review. Its family tree reaches back 9 generations to 1994. 12 later devices descend from it. It has been recalled once.
- Decided
- Nov 6, 2019
- Review
- 85 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931641 (1994). 107 ancestors in all, the oldest K810258 (1981). 12 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations between
- 3 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 2 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 1 generation backK162719 iTotal® Hip Replacement SystemConformis, Inc. · 2017 · Recalled
- This deviceK192198 Conformis Hip SystemConformis, Inc. · 2019
- Descendant · cites it directly · 8 of its ownK213389 Identity Imprint Cruciate Retaining (CR) Knee Replacement System and…Conformis, Inc. · 2021
- Descendant · cites it directly · 7 of its ownK221059 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2022
- Descendant · 2 generations on · 6 of its ownK221404 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK223316 Identity Imprint Porous Total Knee Replacement System, Identity…Conformis, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK230846 iTotal Identity Knee Replacement System; Identity Imprint Knee…Conformis, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 8 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 7 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 6 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 5 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 4 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 3 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 2 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 1 generation backK162719 iTotal® Hip Replacement SystemConformis, Inc. · 2017 · Recalled
- This deviceK192198 Conformis Hip SystemConformis, Inc. · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc. · 2021 · cites it directly8descendants
- K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc. · 2022 · cites it directly7descendants
- K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc. · 2022 · 2 generations on6descendants
- K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc. · 2023 · 3 generations on2descendants
- K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −8 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −7 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −6 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −5 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −4 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −3 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −2 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| −1 | K162719 | iTotal® Hip Replacement System | Conformis, Inc. | 2017 | 4 |
| 0 (this device) | K192198 | Conformis Hip System | Conformis, Inc. | 2019 | — |
| +1 | K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity… | Conformis, Inc. | 2021 | — |
| +1 | K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2022 | — |
| +2 | K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2022 | — |
| +3 | K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous… | Conformis, Inc. | 2023 | — |
| +3 | K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement… | Conformis, Inc. | 2023 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 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 |
|---|---|---|---|
| * | K162719 | iTotal® Hip Replacement SystemSummary page 4…Conformis iTotal Hip Replacement System (ITOTAL HRS) Device Class: II Product Code: LPH, LZO, MEH, OQG Regulation Number: 21 CFR 888.3358 510(k) Number: K162719 1 510(K) SUMMARY (PAGE 2 O… | 2017 |
What descends from it? (12)
See all 124 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 |
|---|---|---|---|---|
| Sep 21, 2020 | Class II | Z-0475-2021 | Process control | Incorrect hip components were provided in kits. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 17 of the 107 ancestors have a recall of any class.
- Of its descendants, K213389 (Conformis, Inc., 2021) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K162719.
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. 2019, 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 Conformis Hip 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 Conformis Hip 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…
Read the full statement (143 words)
The Conformis Hip 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 Conformis Hip 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 Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
The Conformis Hip System 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/K192198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192198: Conformis Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192198
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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