510(k) · Cleared

Cleared

Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts

K991952510(k) SpecialCleared Jun 29, 199919-day reviewClass II21 CFR 888.3353

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

Howmedica Osteonics Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jun 29, 1999 as substantially equivalent to K971409 (Osteonics Corp., 1997) and 2 other predicates after a 19-day review. Its family tree reaches back 1 generation to 1997. 20 later devices descend from it.

Decided: Jun 29, 1999
Review: 19 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K971409 (1997). 3 ancestors in all. 20 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK971409 Osteonics Alumina C-Taper HeadOsteonics Corp. · 1997
This deviceK991952 Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene InsertsHowmedica Osteonics Corp. · 1999
Descendant · cites it directly · 18 of its ownK041940 Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta)…Howmedica Osteonics Corp. · 2005
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

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2005high 4 (2022) · low 0 (2006)2026

Most influential descendants

Showing 5 of 20 · See all

K041940Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral HeadsHowmedica Osteonics Corp. · 2005 · cites it directly18descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971409	Osteonics Alumina C-Taper Head	Osteonics Corp.	1997	—
0 (this device)	K991952	Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts	Howmedica Osteonics Corp.	1999	—
+1	K041940	Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral…	Howmedica Osteonics Corp.	2005	—
+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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2016	1	0
2017	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 K991952, 1997–2026Source: 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 LZO? 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 LZO device

#1 K192827 Quadra-Pscore 19.3 · 10 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? (3)

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
*	K971409	Osteonics Alumina C-Taper Head Summary page 2 …predicate devices identified above—is based on equivalence in intended use, materials, design, indications and contraindications to the Osteonics® Alumina C-Taper Heads (K971409) and the Osteonics® Trident™ Polyethylene Inserts (Osteonics® Generation II Cup Inserts; K983382, K983502). Page 2 === Page 3 =…	Osteonics Corp.	1997	—
*	K983382	Osteonics HA Generation II Acetabular Component System Summary page 2 …dications and contraindications to the Osteonics® Alumina C-Taper Heads (K971409) and the Osteonics® Trident™ Polyethylene Inserts (Osteonics® Generation II Cup Inserts; K983382, K983502). Page 2 o umc.,_%’ ‘5 . . 5' “( DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service o, e Foo…	Osteonics Corp.	1998	4
*	K983502	Osteonics Secur-Fit AD Generation II Acetabular Component System Summary page 2 …and contraindications to the Osteonics® Alumina C-Taper Heads (K971409) and the Osteonics® Trident™ Polyethylene Inserts (Osteonics® Generation II Cup Inserts; K983382, K983502). Page 2 o umc.,_%’ ‘5 . . 5' “( DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service o, e Food and Dru…	Osteonics Corp.	1998	1

Also cleared against K971409: 3 other devices →

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K041940	Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral Heads	Howmedica Osteonics Corp.	2005	18
K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	17
K261624	Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2026	0
K162125	MALUC™ Total Hip Arthroplasty System	Surgtech, Inc.	2017	0

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?

2 of the 3 ancestors have a recall of any class.
Of its descendants, K041940 (Howmedica Osteonics Corp., 2005) has gone furthest, with 18 descendants of its own.
3 other devices also cite its predicate K971409.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZO

14in 2025

2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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	9	87	2	138
2008	11	63	13	125
2009	7	83	42	189
2010	15	78	0	394
2011	13	87	10	544
2012	14	98	14	963
2013	26	100	0	1,370
2014	13	85	1	1,477
2015	12	115	1	1,348
2016	10	177	9	1,728
2017	16	257	5	2,165
2018	18	163	2	3,133
2019	28	109	4	3,066
2020	18	112	3	1,963
2021	12	170	0	2,199
2022	11	279	4	1,985
2023	10	122	2	2,066
2024	11	111	1	2,586
2025	14	119	1	3,244
2026	9	102	0	—

What is it indicated for?

The indications for the use of these ceramic bearing heads and polyethylene inserts are in keeping with those of other legally marketed Osteonics ceramic bearing heads and polyethylene inserts are as follows: Indications: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previously failed cup arthroplasty or other procedure.…

Read the full statement (99 words)

Indications:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.

Revision of previously failed cup arthroplasty or other procedure.

Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

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/K991952 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991952: Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991952

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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