510(k) · Cleared

Cleared

36MM Orthinox V40 Femoral Head Components

K031730510(k) SpecialCleared Aug 29, 200386-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

Howmedica Osteonics Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Aug 29, 2003 as substantially equivalent to K011623 (Howmedica Osteonics Corp., 2001) after an 86-day review. Its family tree reaches back 1 generation to 2001. 18 later devices descend from it.

Decided: Aug 29, 2003
Review: 86 days
Class: Class II
Product code: JDI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011623 (2001). 18 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011623 Exeter Hip System with V40 TaperHowmedica Osteonics Corp. · 2001
This deviceK031730 36MM Orthinox V40 Femoral Head ComponentsHowmedica Osteonics Corp. · 2003
Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
Descendant · 2 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
Descendant · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
Descendant · 2 generations on · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2016high 4 (2022) · low 0 (2017)2026

Most influential descendants

Showing 5 of 18 · See all

K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants
K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 2 generations on7descendants
K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 2 generations on6descendants
K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011623	Exeter Hip System with V40 Taper	Howmedica Osteonics Corp.	2001	—
0 (this device)	K031730	36MM Orthinox V40 Femoral Head Components	Howmedica Osteonics Corp.	2003	—
+1	K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	1
+2	K173499	Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads	Stryker Orthopaedics	2018	2
+2	K182468	Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II…	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics	2019	—
+2	K220731	Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem	Stryker	2022	—
+2	K193429	Exeter V40 Femoral Stem, Exeter X3 RimFit Cup	Howmedica Osteonics Corp.	2020	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2018	1	0
2019	2	0
2020	1	0
2021	1	0
2022	4	0
2023	1	0
2024	2	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K031730, 2001–2026Source: 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 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K011623	Exeter Hip System with V40 Taper	Howmedica Osteonics Corp.	2001	—

Also cleared against K011623: 8 other devices →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	17

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?

Its one ancestor has no recall.
Of its descendants, K153345 (Stryker Orthopaedics, 2016) has gone furthest, with 17 descendants of its own.
8 other devices also cite its predicate K011623.

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

2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

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

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

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 subject Exeter V40TMHip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.

Indications:

0 Noninflammatory joint disease including osteoarthritis and avascular necrosis,

0 Rheumatoid arthritis,

0 Correction of functional deformity,

0 Revision procedures where other treatments or devices have failed,

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031730 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031730: 36MM Orthinox V40 Femoral Head Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031730

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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