510(k) Report

510(k) · Cleared

Cleared

EXETER Centralizer, EXETER 2.5mm Plug

K191414510(k) TraditionalCleared Aug 28, 201992-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

Stryker Orthopaedics · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Aug 28, 2019 as substantially equivalent to K974054 (Howmedica, Inc., 1997) and 3 other predicates after a 92-day review. Its family tree reaches back 10 generations to 1994. 5 later devices descend from it.

Decided
Aug 28, 2019
Review
92 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
4

Its longest line of descent runs back 10 generations to K921308 (1994). 131 ancestors in all, the oldest K891454 (1989). 5 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 6 other ancestors1998: 8 other ancestors1997: 7 other ancestors2014: 2 other ancestors2013: 2 other ancestors2012: 1 other ancestor2011: 4 other ancestors2005: 7 other ancestors1995: 10 other ancestors1994: 9 other ancestors1989: 2 other ancestors2015: 1 other ancestor2009: 2 other ancestors2008: 1 other ancestor2007: 2 other ancestors2006: 5 other ancestors2004: 3 other ancestors2003: 6 other ancestors2002: 12 other ancestors2000: 11 other ancestors1999: 5 other ancestors1996: 7 other ancestors1992: 2 other ancestors1991: 4 other ancestors1990: 2 other ancestors2023: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant cleared2026: 1 descendant clearedReference device: K171768 · Trident® II Acetabular System · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · recalledK921308 · HG Multilock Hip Prosthesis W/ TI-Nidium · Zimmer, Inc. · 1994 · recalledK972893 · Partnership Revision Femoral Stems · Howmedica Corp. · 1997K983404 · Type 3 Femoral Components · Howmedica Corp. · 1998 · recalledK013106 · 2 Piece Modular Hip Stem · Howmedica Osteonics Corp. · 2002 · recalledK103479 · Novel Tapered Hip Stem · Stryker Corp. · 2011K120578 · Accolade II Hip Stem · Howmedica Osteonics · 2012 · recalledK122853 · Novel Fit and Fill Stem · Howmedica Osteonics Corp. · 2013K143085 · Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach · Stryker Orthopaedics · 2015 · recalledK153345 · Stryker Orthopaedics Hip Systems Labeling Update · Stryker Orthopaedics · 2016 · recalledK173499 · Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads · Stryker Orthopaedics · 2018 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 8 other ancestors3 generations back: 58 other ancestors4 generations back: 33 other ancestors5 generations back: 12 other ancestors6 generations back: 7 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants K173499 · Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads · Stryker Orthopaedics · 2018 · recalledK153345 · Stryker Orthopaedics Hip Systems Labeling Update · Stryker Orthopaedics · 2016 · recalledK143085 · Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach · Stryker Orthopaedics · 2015 · recalledK122853 · Novel Fit and Fill Stem · Howmedica Osteonics Corp. · 2013K120578 · Accolade II Hip Stem · Howmedica Osteonics · 2012 · recalledK103479 · Novel Tapered Hip Stem · Stryker Corp. · 2011K013106 · 2 Piece Modular Hip Stem · Howmedica Osteonics Corp. · 2002 · recalledK983404 · Type 3 Femoral Components · Howmedica Corp. · 1998 · recalledK972893 · Partnership Revision Femoral Stems · Howmedica Corp. · 1997K921308 · HG Multilock Hip Prosthesis W/ TI-Nidium · Zimmer, Inc. · 1994 · recalled−10−50
  1. Root · 10 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
  2. 6 generations between
  3. 3 generations backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
  4. 2 generations backK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
  5. 1 generation backK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
  6. This deviceK191414 EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019
  7. Descendant · cites it directly · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
  8. Descendant · 2 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
  9. Descendant · 2 generations on · 0 of its ownK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · Recalled
  10. Descendant · 2 generations on · 0 of its ownK250989 Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025
  11. Descendant · 2 generations on · 0 of its ownK240418 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
Show all 10 generations
  1. Root · 10 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
  2. 9 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
  3. 8 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
  4. 7 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
  5. 6 generations backK103479 Novel Tapered Hip StemStryker Corp. · 2011
  6. 5 generations backK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
  7. 4 generations backK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
  8. 3 generations backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
  9. 2 generations backK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
  10. 1 generation backK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
  11. This deviceK191414 EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019

Most influential descendants

Showing 5 of 5 · See all
  • K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · cites it directly4descendants
  • K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 2 generations on2descendants
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · 2 generations on0descendants
  • K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025 · 2 generations on0descendants
  • K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K921308HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc.19941
−9K972893Partnership Revision Femoral StemsHowmedica Corp.1997—
−8K983404Type 3 Femoral ComponentsHowmedica Corp.19981
−7K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200237
−6K103479Novel Tapered Hip StemStryker Corp.2011—
−5K120578Accolade II Hip StemHowmedica Osteonics20121
−4K122853Novel Fit and Fill StemHowmedica Osteonics Corp.2013—
−3K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics20152
−2K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics20161
−1K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics20182
0 (this device)K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics2019—
+1K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023—
+2K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025—
+2K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20262
+2K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)2025—
+2K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198920
199020
199140
199220
199490
1995100
199670
199770
199880
199950
2000110
200160
2002120
200360
200430
200570
200650
200720
200810
200920
201140
201210
201320
201420
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202410
202520
202610
FIG. 1 — Lineage of K191414, 1994–2026Source: 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? (4)

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
*K974054Distal Centralizer, Exeter II Hip System
Summary page 4
…CFR § 888.3350 Product Codes: JDI, LZN Legally Marketed Device to which Substantial Equivalence is Claimed: EXETER Centralizer - K974054, K011623 EXETER 2.5mm Intramedullary Plug - K980843, K011623, K173499 Device Description: The subject devices, EXETER Centraliz…
Howmedica, Inc.19973
*K011623Exeter Hip System with V40 Taper
Summary page 4
…CFR § 888.3350 Product Codes: JDI, LZN Legally Marketed Device to which Substantial Equivalence is Claimed: EXETER Centralizer - K974054, K011623 EXETER 2.5mm Intramedullary Plug - K980843, K011623, K173499 Device Description: The subject devices, EXETER Centralizer and EX…
Howmedica Osteonics Corp.2001—
*K980843Exeter Intramedullary Bone Plug
Summary page 4
…odes: JDI, LZN Legally Marketed Device to which Substantial Equivalence is Claimed: EXETER Centralizer - K974054, K011623 EXETER 2.5mm Intramedullary Plug - K980843, K011623, K173499 Device Description: The subject devices, EXETER Centralizer and EXETER 2.5mm Intramedullary Plug, are a modif…
Howmedica, Inc.1998—
*K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
Summary page 4
…DI, LZN Legally Marketed Device to which Substantial Equivalence is Claimed: EXETER Centralizer - K974054, K011623 EXETER 2.5mm Intramedullary Plug - K980843, K011623, K173499 Device Description: The subject devices, EXETER Centralizer and EXETER 2.5mm Intramedullary Plug, are a modified version of the…
Stryker Orthopaedics20182
†K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics201712

Also cleared against K974054: 7 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234

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 25 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
  • 48 of the 131 ancestors have a recall of any class.
  • Of its descendants, K233498 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2023) has gone furthest, with 4 descendants of its own.
  • 7 other devices also cite its predicate K974054.

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. 2019, this device’s year, is highlighted.

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?

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The EXETER Centralizer is intended to be used to centralize the…

Read the full statement (116 words)

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

2. rheumatoid arthritis;

3. correction of functional deformity;

4. revision procedures where other treatments or devices have failed; and,

5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The EXETER Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement.

The EXETER 2.5mm Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K974054

7 other devices cite the same predicate.

  • K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc. · 2018
  • K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2018
  • K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone PlugCorentec Co., Ltd. · 20161 recall
  • K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal…Signature Orthopaedics Pty Limited · 2014
  • K983136Depuy Luster StemDePuy Orthopaedics, Inc. · 199810 recalls
  • K982918Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 1998

More from Stryker Orthopaedics

24 FDA decisions under this applicant name. See the company

  • K211703Insignia Hip StemStryker Orthopaedics · 2021
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 20182 recalls
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 20183 recalls
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 20171 recall
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 20161 recall

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/K191414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191414: EXETER Centralizer, EXETER 2.5mm Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191414

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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