510(k) · Cleared
Recalled · Class II · 2025Cordera 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 Sep 24, 2020 as substantially equivalent to K190904 (Conformis, Inc., 2019) and 2 other predicates after a 24-day review. Its family tree reaches back 10 generations to 1994. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 24, 2020
- Review
- 24 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 10 generations to K931641 (1994). 109 ancestors in all, the oldest K810258 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 6 generations between
- 3 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 2 generations backK162719 iTotal® Hip Replacement SystemConformis, Inc. · 2017 · Recalled
- 1 generation backK190904 Conformis BeneFIT Hip SystemConformis, Inc. · 2019 · Recalled
- This deviceK202484 Cordera Hip SystemConformis, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK221104 Actera™ hip systemConformis, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK231178 ACTERA™ hip systemConformis, Inc. · 2023
Show all 10 generations
- Root · 10 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 8 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 7 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 6 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 5 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 4 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 3 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 2 generations backK162719 iTotal® Hip Replacement SystemConformis, Inc. · 2017 · Recalled
- 1 generation backK190904 Conformis BeneFIT Hip SystemConformis, Inc. · 2019 · Recalled
- This deviceK202484 Cordera Hip SystemConformis, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −9 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −8 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −7 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −6 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −5 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −4 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −3 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| −2 | K162719 | iTotal® Hip Replacement System | Conformis, Inc. | 2017 | 4 |
| −1 | K190904 | Conformis BeneFIT Hip System | Conformis, Inc. | 2019 | 1 |
| 0 (this device) | K202484 | Cordera Hip System | Conformis, Inc. | 2020 | — |
| +1 | K221104 | Actera™ hip system | Conformis, Inc. | 2022 | 1 |
| +2 | K231178 | ACTERA™ hip system | 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 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K190904 | Conformis BeneFIT Hip SystemSummary page 4…Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (LPH, OQG) Legally Marketed Predicate Device (Primary Predicate): BeneFIT Hip System (K190904) (Secondary Predicates): Conformis Hip System (K162719, K192198)… | 2019 |
| * | K162719 | iTotal® Hip Replacement SystemSummary page 4…ated uncemented prosthesis (LPH, OQG) Legally Marketed Predicate Device (Primary Predicate): BeneFIT Hip System (K190904) (Secondary Predicates): Conformis Hip System (K162719, K192198) K202484 - Page 2 o… | 2017 |
| * | K192198 | Conformis Hip SystemSummary page 4…mented prosthesis (LPH, OQG) Legally Marketed Predicate Device (Primary Predicate): BeneFIT Hip System (K190904) (Secondary Predicates): Conformis Hip System (K162719, K192198) K202484 - Page 2 of 3 De… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221104 | Actera™ hip system | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2025 | Class II | Z-1569-2025 | Labeling Change Control | The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner. |
| Jun 16, 2023 | Class II | Z-2405-2023 | Error in labeling | 30mm screws were labeled as 25mm screws. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 19 of the 109 ancestors have a recall of any class.
- Of its descendants, K221104 (Conformis, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K190904.
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. 2020, 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 Cordera™ Hip System may be used with iJigs® designed from a patient’s pre-operative CT scan, which must include certain necessary anatomic landmarks that are clearly identifiable. The Cordera™ 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.…
Read the full statement (139 words)
The Cordera™ Hip System may be used with iJigs® designed from a patient’s pre-operative CT scan, which must include
certain necessary anatomic landmarks that are clearly identifiable. The Cordera™ 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 Cordera™ Hip System includes standard hip replacement components, and if selected, may use patient-specific single
use instrumentation.
The Conformis Cordera 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/K202484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202484: Cordera 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/K202484
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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