510(k) · Cleared
ClearedModification to Depuy C-Stem System
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 7, 2001 as substantially equivalent to K982918 (DePuy Orthopaedics, Inc., 1998) after a 29-day review. Its family tree reaches back 4 generations to 1989. 14 later devices descend from it.
- Decided
- Nov 7, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K891454 (1989). 11 ancestors in all, the oldest K802627 (1980). 14 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK891454 Exeter II Total Hip SystemHowmedica Corp. · 1989
- 3 generations backK974054 Distal Centralizer, Exeter II Hip SystemHowmedica, Inc. · 1997 · Recalled
- 2 generations backK980843 Exeter Intramedullary Bone PlugHowmedica, Inc. · 1998
- 1 generation backK982918 Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 1998
- This deviceK013350 Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 2001
- Descendant · cites it directly · 7 of its ownK152084 Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with…Corentec Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
- Descendant · cites it directly · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- Descendant · 3 generations on · 4 of its ownK172806 Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK182221 Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd. · 2016 · cites it directly7descendants
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 2 generations on6descendants
- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · cites it directly5descendants
- K172806Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2017 · 3 generations on4descendants
- K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K891454 | Exeter II Total Hip System | Howmedica Corp. | 1989 | — |
| −3 | K974054 | Distal Centralizer, Exeter II Hip System | Howmedica, Inc. | 1997 | 3 |
| −2 | K980843 | Exeter Intramedullary Bone Plug | Howmedica, Inc. | 1998 | — |
| −1 | K982918 | Depuy C-Stem System | DePuy Orthopaedics, Inc. | 1998 | — |
| 0 (this device) | K013350 | Modification to Depuy C-Stem System | DePuy Orthopaedics, Inc. | 2001 | — |
| +1 | K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with… | Corentec Co., Ltd. | 2016 | 1 |
| +2 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
| +1 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +3 | K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017 | — |
| +3 | K182221 | Bencox Mirabo Cup Multi Hole | Corentec Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K982918 | Depuy C-Stem SystemSummary page 1…is Code: 87JDI No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems. DePuy C-Stem System K982918 The DePuy C-Stem System hip stem is a collarless, slim-profiled, triple-tapered polished stem manufactured from stainless st… | 1998 |
What descends from it? (14)
See all 142 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 3 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K152084 (Corentec Co., Ltd., 2016) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K982918.
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?
The DePuy C-Stem System is indicated for cemented use as the femoral component in total hip arthroplasty. 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: 1. A severely painful and/or disabled joint from…
Read the full statement (120 words)
The DePuy C-Stem System is indicated for cemented use as the femoral component in total hip arthroplasty.
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:
1. A severely painful and/or disabled joint from 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013350 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013350: Modification to Depuy C-Stem System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013350
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026