510(k) · Cleared
ClearedDepuy Summit FX Cemented Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Nov 13, 2002 as substantially equivalent to K013352 (DePuy Orthopaedics, Inc., 2001) after a 29-day review. Its family tree reaches back 2 generations to 1990. 29 later devices descend from it.
- Decided
- Nov 13, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900638 (1990). 4 ancestors in all. 29 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK900638 P.F.C. Hip System Non-Porous Femoral ComponentJohnson & Johnson International · 1990
- 1 generation backK013352 Summit Cemented Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- This deviceK023453 Depuy Summit FX Cemented Hip ProsthesisDePuy Orthopaedics, Inc. · 2002
- Descendant · cites it directly · 27 of its ownK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- Descendant · 2 generations on · 20 of its ownK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- Descendant · 3 generations on · 15 of its ownK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- Descendant · 2 generations on · 13 of its ownK210581 Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC · 2021
- Descendant · 4 generations on · 7 of its ownK211703 Insignia Hip StemStryker Orthopaedics · 2021
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K170339Summit Hip SystemDePuy Orthopaedics, Inc. · 2018 · cites it directly27descendants
- K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020 · 2 generations on20descendants
- K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020 · 3 generations on15descendants
- K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC · 2021 · 2 generations on13descendants
- K211703Insignia Hip StemStryker Orthopaedics · 2021 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900638 | P.F.C. Hip System Non-Porous Femoral Component | Johnson & Johnson International | 1990 | — |
| −1 | K013352 | Summit Cemented Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| 0 (this device) | K023453 | Depuy Summit FX Cemented Hip Prosthesis | DePuy Orthopaedics, Inc. | 2002 | — |
| +1 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| +2 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| +3 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
| +2 | K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | 2021 | — |
| +4 | K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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 |
|---|---|---|---|
| * | K013352 | Summit Cemented Hip Prosthesis | 2001 |
What descends from it? (29)
See all 293 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)
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 12 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K170339 (DePuy Orthopaedics, Inc., 2018) has gone furthest, with 27 descendants of its own.
- 5 other devices also cite its predicate K013352.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: A severely painful andor disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia; Avascular necrosis of the…
Read the full statement (110 words)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Total hip replacement is indicated in the following conditions:
A severely painful andor disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia;
Avascular necrosis of the femoral head;
Acute traumatic fracture of the femoral head or neck;
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
Certain cases of ankylosis.
The Summit FX Cemented Hip Stem is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023453 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023453: Depuy Summit FX Cemented Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023453
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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