510(k) · Cleared

Recalled · Class II · 2021

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads

K173499510(k) TraditionalCleared Mar 19, 2018126-day reviewClass II21 CFR 888.3360Recalls 2

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

Stryker Orthopaedics · JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

Cleared on Mar 19, 2018 as substantially equivalent to K011623 (Howmedica Osteonics Corp., 2001) and 6 other predicates after a 126-day review. Its family tree reaches back 9 generations to 1994. 8 later devices descend from it. It has been recalled 2 times.

Decided: Mar 19, 2018
Review: 126 days
Class: Class II
Product code: JDG
Recalls: 2
Predicates: 7

Its longest line of descent runs back 9 generations to K921308 (1994). 125 ancestors in all, the oldest K894124 (1989). 8 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 9 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
5 generations between
3 generations backK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
2 generations backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
1 generation backK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
This deviceK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018
Descendant · cites it directly · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled
Descendant · 2 generations on · 5 of its ownK213701 Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022
Descendant · cites it directly · 5 of its ownK191414 EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019
Descendant · cites it directly · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
Descendant · 2 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025

Show all 9 generations

Root · 9 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
8 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
7 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
6 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
5 generations backK103479 Novel Tapered Hip StemStryker Corp. · 2011
4 generations backK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
3 generations backK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
2 generations backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
1 generation backK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
This deviceK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2019high 2 (2025) · low 0 (2021)2026

Most influential descendants

Showing 5 of 8 · See all

K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · cites it directly6descendants
K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022 · 2 generations on5descendants
K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019 · cites it directly5descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K921308	HG Multilock Hip Prosthesis W/ TI-Nidium	Zimmer, Inc.	1994	1
−8	K972893	Partnership Revision Femoral Stems	Howmedica Corp.	1997	—
−7	K983404	Type 3 Femoral Components	Howmedica Corp.	1998	1
−6	K013106	2 Piece Modular Hip Stem	Howmedica Osteonics Corp.	2002	37
−5	K103479	Novel Tapered Hip Stem	Stryker Corp.	2011	—
−4	K120578	Accolade II Hip Stem	Howmedica Osteonics	2012	1
−3	K122853	Novel Fit and Fill Stem	Howmedica Osteonics Corp.	2013	—
−2	K143085	Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…	Stryker Orthopaedics	2015	2
−1	K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	1
0 (this device)	K173499	Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads	Stryker Orthopaedics	2018	—
+1	K193429	Exeter V40 Femoral Stem, Exeter X3 RimFit Cup	Howmedica Osteonics Corp.	2020	1
+2	K213701	Exeter® X3® RimFit® Cup	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2022	—
+1	K191414	EXETER Centralizer, EXETER 2.5mm Plug	Stryker Orthopaedics	2019	—
+1	K233498	Stryker Orthopaedics Hip Systems Labeling Update	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2023	—
+2	K243784	Stryker Orthopaedics Hip Devices Labeling Update	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	2	0
1991	4	0
1992	2	0
1994	8	0
1995	9	0
1996	7	0
1997	6	0
1998	7	0
1999	5	0
2000	11	0
2001	6	0
2002	12	0
2003	6	0
2004	3	0
2005	7	0
2006	5	0
2007	2	0
2008	1	0
2009	2	0
2011	4	0
2012	1	0
2013	2	0
2014	2	0
2015	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2020	1	0
2022	1	0
2023	1	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K173499, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JDG? 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 JDG device

#1 K212431 Biomet Answer/Impact/Integral Distal…score 3.1 · 2 generations · no Class I recall
#2 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K011623	Exeter Hip System with V40 Taper Summary page 4 …rosthesis 21 CFR §888.3390 Product Codes: JDI, LZO, JDG, KWY Legally Marketed Device to Which Substantial Equivalence is Claimed: Exeter V40 Femoral Stems – K011623, K110290, K121308, K153345 Accolade HFx Femoral Stems – K051741, K121308…	Howmedica Osteonics Corp.	2001	—
*	K110290	Exeter Hip Stem Summary page 4 …21 CFR §888.3390 Product Codes: JDI, LZO, JDG, KWY Legally Marketed Device to Which Substantial Equivalence is Claimed: Exeter V40 Femoral Stems – K011623, K110290, K121308, K153345 Accolade HFx Femoral Stems – K051741, K121308…	Howmedica Osteonics Corp.	2011	1
*	K121308	Hip Systems Summary page 4 …888.3390 Product Codes: JDI, LZO, JDG, KWY Legally Marketed Device to Which Substantial Equivalence is Claimed: Exeter V40 Femoral Stems – K011623, K110290, K121308, K153345 Accolade HFx Femoral Stems – K051741, K121308…	Howmedica Osteonics Corp.	2012	7
*	K153345	Stryker Orthopaedics Hip Systems Labeling Update Summary page 4 …Product Codes: JDI, LZO, JDG, KWY Legally Marketed Device to Which Substantial Equivalence is Claimed: Exeter V40 Femoral Stems – K011623, K110290, K121308, K153345 Accolade HFx Femoral Stems – K051741, K121308…	Stryker Orthopaedics	2016	1
*	K051741	Accolade HFX Femoral Stem Summary page 4 …G, KWY Legally Marketed Device to Which Substantial Equivalence is Claimed: Exeter V40 Femoral Stems – K011623, K110290, K121308, K153345 Accolade HFx Femoral Stems – K051741, K121308 K173499…	Stryker Orthopaedics	2005	—
*	K130610	Sirius Femoral Stem Summary page 5 …K173499 PAGE 2 OF 3 Biomet Sirius Femoral Hip Stem – K130610, K142295 Device Description: The Exeter® V40™ Femoral Stems/Orthinox Femoral Heads are sterile, single-use components intended…	Biomet, Inc.	2013	2
*	K142295	Sirius Femoral Stem, Size 30A Summary page 5 …K173499 PAGE 2 OF 3 Biomet Sirius Femoral Hip Stem – K130610, K142295 Device Description: The Exeter® V40™ Femoral Stems/Orthinox Femoral Heads are sterile, single-use components intended for cemen…	Biomet, Inc.	2014	—

Also cleared against K011623: 8 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K193429	Exeter V40 Femoral Stem, Exeter X3 RimFit Cup	Howmedica Osteonics Corp.	2020	6
K191414	EXETER Centralizer, EXETER 2.5mm Plug	Stryker Orthopaedics	2019	5
K233498	Stryker Orthopaedics Hip Systems Labeling Update	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2023	4
K261624	Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2026	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 15, 2021	Class II	Z-0313-2022	Under Investigation by firm	XXX
Oct 15, 2021	Class II	Z-0314-2022	Under Investigation by firm	There is a potential for the outer white Tyvek lid to debond from the sealed package.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
45 of the 125 ancestors have a recall of any class.
Of its descendants, K193429 (Howmedica Osteonics Corp., 2020) has gone furthest, with 6 descendants of its own.
8 other devices also cite its predicate K011623.

How does its category compare?

All JDG devices

JDG Prosthesis, Hip, Femoral Component, Cemented, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · JDG

1in 2022

2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDG

Too few JDG 510(k)s in any year since 2007 to give a median.

Recalls per year · JDG

4in 2021

2007high 4 (2021) · low 0 (2007)2026

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

Adverse event reports per year · JDG

263in 2025

2007high 1,206 (2021) · low 19 (2008)2025

MAUDE reports naming product code JDG, 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	0	—	0	28
2008	0	—	0	19
2009	0	—	2	38
2010	0	—	0	37
2011	0	—	0	25
2012	0	—	0	49
2013	0	—	3	84
2014	0	—	0	145
2015	0	—	0	391
2016	0	—	0	383
2017	0	—	0	328
2018	1	—	0	447
2019	0	—	0	333
2020	1	—	0	1,046
2021	0	—	4	1,206
2022	1	—	0	886
2023	0	—	0	289
2024	0	—	0	300
2025	0	—	0	263
2026	0	—	0	—

What is it indicated for?

The Exeter® V40™ Femoral Stem Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only.

The Exeter® V40™ Femoral Stem Hip System is indicated for:

» noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

» theumatoid arthritis;

» correction of functional deformity;

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

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

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/K173499 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173499

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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