510(k) · Cleared

Recalled · Class II · 2014

Zimmer Trabecular Metal Modular Acetabular System

K021891510(k) TraditionalCleared Sep 5, 200290-day reviewClass II21 CFR 888.3358Recalls 3

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

Zimmer, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Sep 5, 2002 as substantially equivalent to K934765 (Zimmer, Inc., 1994) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1994. 248 later devices descend from it. It has been recalled 3 times.

Decided: Sep 5, 2002
Review: 90 days
Class: Class II
Product code: LPH
Recalls: 3
Predicates: 2

Its longest line of descent runs back 1 generation to K934765 (1994). 2 ancestors in all. 248 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK934765 Trilogy Acetabular SystemZimmer, Inc. · 1994 · Recalled
This deviceK021891 Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. · 2002
Descendant · cites it directly · 246 of its ownK091508 Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular…Zimmer, Inc. · 2009 · Recalled
Descendant · 2 generations on · 144 of its ownK093846 Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc. · 2010
Descendant · 2 generations on · 143 of its ownK101229 Longevity IT Highly Crosslinked Polyethylene Elevated Liners…Zimmer, Inc. · 2010
Descendant · 2 generations on · 137 of its ownK103662 Continuum and Trilogy Integrated Taper (IT) Acetabular Systems…Zimmer, Inc. · 2011
Descendant · 2 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011

Showing 5 of 248 descendants. See all descendants

Descendants cleared per year

2009high 27 (2026) · low 1 (2009)2026

Most influential descendants

Showing 5 of 248 · See all

K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemZimmer, Inc. · 2009 · cites it directly246descendants
K093846Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc. · 2010 · 2 generations on144descendants
K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular…Zimmer, Inc. · 2010 · 2 generations on143descendants
K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Zimmer, Inc. · 2011 · 2 generations on137descendants
K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 2 generations on109descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934765	Trilogy Acetabular System	Zimmer, Inc.	1994	16
0 (this device)	K021891	Zimmer Trabecular Metal Modular Acetabular System	Zimmer, Inc.	2002	—
+1	K091508	Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System	Zimmer, Inc.	2009	3
+2	K093846	Longevity IT Highly Crosslinked Polyethylene Elevated Liners	Zimmer, Inc.	2010	—
+2	K101229	Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum…	Zimmer, Inc.	2010	—
+2	K103662	Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT…	Zimmer, Inc.	2011	—
+2	K110087	Corin Trinity Acetbular System with Hxlpe Liners	Corin USA	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	4	0
2011	3	0
2012	11	0
2013	13	0
2014	6	0
2015	8	0
2016	9	0
2017	8	0
2018	17	0
2019	25	0
2020	20	0
2021	13	0
2022	18	0
2023	18	0
2024	21	0
2025	26	0
2026	27	0

FIG. 1 — Lineage of K021891, 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 LPH? 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 LPH device

#1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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? (2)

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
*	K934765	Trilogy Acetabular System Summary page 1 …21 CFR 5 888.3358 Predicate Device: Trilob?F Acetabular System, manufactured by Zimmer, Inc., (K934765), cleared April 29, 1994; and Implex Hedrocel Modular Elliptical Acetabular…	Zimmer, Inc.	1994	16
*	K001039	The Implex Hedrocel Modular Elliptical Acetabular Cup	Implex Corp.	2000	—

Also cleared against K934765: 11 other devices →

What descends from it? (248)

See all 248

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

Number	Device	Applicant	Decided	Descendants
K091508	Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System	Zimmer, Inc.	2009	246
K112898	Delta TT Cups, Delta TT Liners, Bone Screws	Lima Corporate S.P.A.	2012	12
K241636	MobileLink Acetabular Cup System - Line Extension (Multiple)	Waldemar Link GmbH & Co. KG	2024	2
K093561	Zimmer Trabecular Metal Modular Acetabular System	Zimmer, Inc.	2010	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 1, 2014	Class II	Z-1496-2014	Nonconforming Material/Component	The shell was missing the locking ring.
Sep 1, 2011	Not classified	Z-3279-2011	Nonconforming Material/Component	Lot # 61132698 and Lot 001122467 (added 9/ 18/2012) may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically, devices in the affected lot may have a locking ring groove depth that…
Aug 18, 2010	Not classified	Z-0060-2011	Other	The threads on the device were not completely machined and therefore would not mate with athe corresponding cup positioner/shell inserter.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K091508 (Zimmer, Inc., 2009) has gone furthest, with 246 descendants of its own.
11 other devices also cite its predicate K934765.

How does its category compare?

All LPH devices

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

FDA decisions per year · LPH

12in 2025

2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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	10	116	16	509
2008	10	86	1	706
2009	3	112	2	1,156
2010	15	100	22	2,007
2011	16	110	26	3,320
2012	25	76	30	3,785
2013	11	135	9	5,002
2014	20	129	3	5,163
2015	18	111	1	5,830
2016	10	150	8	4,900
2017	12	121	14	5,312
2018	9	145	2	5,954
2019	22	164	8	7,130
2020	7	164	6	5,429
2021	8	410	4	5,978
2022	14	247	2	5,223
2023	10	111	2	5,345
2024	6	92	1	5,626
2025	12	153	4	6,163
2026	8	256	2	—

What is it indicated for?

This device is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.

This device is intended for either cemented or noncemented use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021891 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021891: Zimmer Trabecular Metal Modular Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021891

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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