510(k) · Cleared

Recalled · Class II · 2024

Unitrax Modular Unipolar System

K014226510(k) SpecialCleared Jan 25, 200230-day reviewClass II21 CFR 888.3360Recalls 3

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

Howmedica Osteonics Corp. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal

Cleared on Jan 25, 2002 as substantially equivalent to K902365 (Howmedica Corp., 1991) after a 30-day review. Its family tree reaches back 1 generation to 1991. 18 later devices descend from it. It has been recalled 3 times.

Decided: Jan 25, 2002
Review: 30 days
Class: Class II
Product code: KWL
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K902365 (1991). 18 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK902365 Modular Unipolar SystemHowmedica Corp. · 1991
This deviceK014226 Unitrax Modular Unipolar SystemHowmedica Osteonics Corp. · 2002
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	K902365	Modular Unipolar System	Howmedica Corp.	1991	—
0 (this device)	K014226	Unitrax Modular Unipolar System	Howmedica Osteonics Corp.	2002	—
+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 K014226, 1991–2026Source: 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 KWL? 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 KWL device

#1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K902365	Modular Unipolar System Summary page 1 …from ASTM F1537 to ASTM F75. The modified component is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process in 510(k) #K902365. The Unitrax® Modular Unipolar Heads are manufactured from Vitallium® (CoCr) Alloy which conforms to ASTM standards F75 (cast) an…	Howmedica Corp.	1991	—

Also cleared against K902365: 3 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 19, 2024	Class II	Z-2372-2024	Employee error	Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
Jun 19, 2024	Class II	Z-2371-2024	Employee error	Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
Jun 19, 2024	Class II	Z-2370-2024	Employee error	Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

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.
3 other devices also cite its predicate K902365.

How does its category compare?

All KWL devices

KWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWL

3in 2025

2007high 3 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWL

32in 2025

2007high 32 (2025)2026

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

Recalls per year · KWL

2in 2017

2007high 36 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KWL

29in 2025

2007high 415 (2019) · low 11 (2007)2025

MAUDE reports naming product code KWL, 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	2	—	36	11
2008	1	—	0	13
2009	0	—	2	21
2010	0	—	0	55
2011	2	—	0	51
2012	1	—	0	62
2013	0	—	0	89
2014	0	—	0	107
2015	1	—	1	223
2016	0	—	0	210
2017	0	—	2	347
2018	2	—	0	294
2019	1	—	0	415
2020	1	—	0	270
2021	0	—	0	107
2022	1	—	0	99
2023	0	—	0	48
2024	1	—	0	143
2025	3	32	0	29
2026	2	—	1	—

What is it indicated for?

The Unitrax® Modular Unipolar System is intended to be used with a Howmedica Osteonics hip stem. When assembled to a hip stem, the resultant component functions in a similar fashion to a fixed head endoprosthesis. The endoprosthesis is used as a hemi-arthroplasty for the following indications: femoral neck fractures, idiopathic avascular necrosis and non-unions.

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/K014226 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014226: Unitrax Modular Unipolar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014226

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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