510(k) Report

510(k) · Cleared

Cleared

Depuy C-Stem System

K982918510(k) TraditionalCleared Oct 5, 199847-day reviewClass II21 CFR 888.3350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

DePuy Orthopaedics, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Oct 5, 1998 as substantially equivalent to K960658 (Zimmer, Inc., 1996) and 6 other predicates after a 47-day review. Its family tree reaches back 3 generations to 1989. 25 later devices descend from it.

Decided
Oct 5, 1998
Review
47 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K891454 (1989). 10 ancestors in all, the oldest K802627 (1980). 25 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 3 other ancestors1988: 1 other ancestor1980: 1 other ancestor1994: 1 other ancestor2022: 3 descendants cleared2004: 1 descendant cleared2001: 1 descendant cleared2024: 2 descendants cleared2026: 2 descendants cleared2016: 3 descendants cleared2023: 3 descendants cleared2008: 1 descendant cleared2025: 5 descendants cleared2020: 1 descendant cleared2019: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant clearedK891454 · Exeter II Total Hip System · Howmedica Corp. · 1989×2: 2 generations cleared close together, K974054 (1997), K980843 (1998) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 7 descendants3 generations forward: 5 descendants4 generations forward: 8 descendants K980843 · Exeter Intramedullary Bone Plug · Howmedica, Inc. · 1998K974054 · Distal Centralizer, Exeter II Hip System · Howmedica, Inc. · 1997 · recalledK891454 · Exeter II Total Hip System · Howmedica Corp. · 19890
  1. Root · 3 generations backK891454 Exeter II Total Hip SystemHowmedica Corp. · 1989
  2. 2 generations backK974054 Distal Centralizer, Exeter II Hip SystemHowmedica, Inc. · 1997 · Recalled
  3. 1 generation backK980843 Exeter Intramedullary Bone PlugHowmedica, Inc. · 1998
  4. This deviceK982918 Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 1998
  5. Descendant · cites it directly · 23 of its ownK042959 Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004
  6. Descendant · 2 generations on · 14 of its ownK082239 Depuy C-Stem AmtDePuy Orthopaedics, Inc. · 2008
  7. Descendant · cites it directly · 14 of its ownK013350 Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 2001
  8. Descendant · cites it directly · 8 of its ownK220216 C-Stem AMT LE ProsthesisDepuy Ireland UC · 2022
  9. Descendant · 2 generations on · 7 of its ownK152084 Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with…Corentec Co., Ltd. · 2016 · Recalled

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2001: 12004: 12008: 12016: 32017: 12019: 12020: 12021: 12022: 32023: 32024: 22025: 52026: 2
2001high 5 (2025) · low 0 (2002)2026

Most influential descendants

Showing 5 of 25 · See all
  • K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004 · cites it directly23descendants
  • K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc. · 2008 · 2 generations on14descendants
  • K013350Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 2001 · cites it directly14descendants
  • K220216C-Stem AMT LE ProsthesisDepuy Ireland UC · 2022 · cites it directly8descendants
  • K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd. · 2016 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K891454Exeter II Total Hip SystemHowmedica Corp.1989—
−2K974054Distal Centralizer, Exeter II Hip SystemHowmedica, Inc.19973
−1K980843Exeter Intramedullary Bone PlugHowmedica, Inc.1998—
0 (this device)K982918Depuy C-Stem SystemDePuy Orthopaedics, Inc.1998—
+1K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc.2004—
+2K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc.2008—
+1K013350Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc.2001—
+1K220216C-Stem AMT LE ProsthesisDepuy Ireland UC2022—
+2K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with…Corentec Co., Ltd.20161

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198810
199410
199530
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200810
201630
201710
201910
202010
202110
202230
202330
202420
202550
202620
FIG. 1 — Lineage of K982918, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K960658Collarless Polished Taper Hip Prosthesis
Summary page 1
…sthesis CLASSIFICATION: Class II per 888.3350, Hip joint metal/polymer semi- constraincd cemented prosthesis DEVICE CODE: JDI1 EQUIVALENT DEVICES: CPT Hip Prosthesis (K960658) Exeter Total Hip System (K974054, K980843) Ortron 90* Hip Prosthesis (Charnely) (K802627) DePuy Elite Hip (K871867) BIOSTOP® G…
Zimmer, Inc.199614
*K974054Distal Centralizer, Exeter II Hip System
Summary page 1
…er 888.3350, Hip joint metal/polymer semi- constraincd cemented prosthesis DEVICE CODE: JDI1 EQUIVALENT DEVICES: CPT Hip Prosthesis (K960658) Exeter Total Hip System (K974054, K980843) Ortron 90* Hip Prosthesis (Charnely) (K802627) DePuy Elite Hip (K871867) BIOSTOP® G Bone Cement Restrictor (K943727) D…
Howmedica, Inc.19973
*K980843Exeter Intramedullary Bone Plug
Summary page 1
…50, Hip joint metal/polymer semi- constraincd cemented prosthesis DEVICE CODE: JDI1 EQUIVALENT DEVICES: CPT Hip Prosthesis (K960658) Exeter Total Hip System (K974054, K980843) Ortron 90* Hip Prosthesis (Charnely) (K802627) DePuy Elite Hip (K871867) BIOSTOP® G Bone Cement Restrictor (K943727) DePuy Dist…
Howmedica, Inc.1998—
*K802627Ortron 90* Hip Prosthesis
Summary page 1
…emented prosthesis DEVICE CODE: JDI1 EQUIVALENT DEVICES: CPT Hip Prosthesis (K960658) Exeter Total Hip System (K974054, K980843) Ortron 90* Hip Prosthesis (Charnely) (K802627) DePuy Elite Hip (K871867) BIOSTOP® G Bone Cement Restrictor (K943727) DePuy Distal Stem Centralizers (K95193 0) DEVICE DESCRIP…
Cintor Orthopaedic Div.1980—
*K871867Elite Modular Hip System
Summary page 1
…CODE: JDI1 EQUIVALENT DEVICES: CPT Hip Prosthesis (K960658) Exeter Total Hip System (K974054, K980843) Ortron 90* Hip Prosthesis (Charnely) (K802627) DePuy Elite Hip (K871867) BIOSTOP® G Bone Cement Restrictor (K943727) DePuy Distal Stem Centralizers (K95193 0) DEVICE DESCRIPTION AND INTENDED USE: Th…
Thackray USA1988—
*K943727Biostop G Bone Cement Restrictor
Summary page 1
…thesis (K960658) Exeter Total Hip System (K974054, K980843) Ortron 90* Hip Prosthesis (Charnely) (K802627) DePuy Elite Hip (K871867) BIOSTOP® G Bone Cement Restrictor (K943727) DePuy Distal Stem Centralizers (K95193 0) DEVICE DESCRIPTION AND INTENDED USE: The subject DePuy C-Stem System includes stainl…
Landos, Inc.19951
*K951930Cementralizer Distal Stem Centralizer
Summary page 1
…(K974054, K980843) Ortron 90* Hip Prosthesis (Charnely) (K802627) DePuy Elite Hip (K871867) BIOSTOP® G Bone Cement Restrictor (K943727) DePuy Distal Stem Centralizers (K95193 0) DEVICE DESCRIPTION AND INTENDED USE: The subject DePuy C-Stem System includes stainless steel femoral stems, a gelatin end cap…
Depuy, Inc.1995—

Also cleared against K960658: 4 other devices →

What descends from it? (25)

See all 25

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc.200423
K013350Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc.200114
K220216C-Stem AMT LE ProsthesisDepuy Ireland UC20228
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245
K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260

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 9 years and passes through 3 companies; a new generation was cleared every 5 months on median.
  • 4 of the 10 ancestors have a recall of any class.
  • Of its descendants, K042959 (DePuy Orthopaedics, Inc., 2004) has gone furthest, with 23 descendants of its own.
  • 4 other devices also cite its predicate K960658.

How does its category compare?

All JDI devices

JDI 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

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

What is it indicated for?

The DePuy C-Stem System is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient with a severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or theumnatoid arthritis: avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and 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.

Also cleared against K960658

4 other devices cite the same predicate.

  • K191735CPT Hip SystemZimmer, Inc. · 2020
  • K130610Sirius Femoral StemBiomet, Inc. · 20132 recalls
  • K030265CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00Zimmer, Inc. · 20033 recalls
  • K983136Depuy Luster StemDePuy Orthopaedics, Inc. · 199810 recalls

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

Recent decisions in JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K982918 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982918: Depuy C-Stem System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982918

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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