510(k) · Cleared

Cleared

Modification to Trident All Poly Cup

K010310510(k) SpecialCleared Mar 20, 200147-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 Mar 20, 2001 as substantially equivalent to K001956 (Howmedica Osteonics Corp., 2000) after a 47-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: Mar 20, 2001
Review: 47 days
Class: Class II
Product code: JDI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001956 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK001956 Trident All Poly CupHowmedica Osteonics Corp. · 2000
This deviceK010310 Modification to Trident All Poly CupHowmedica Osteonics Corp. · 2001
Descendant · cites it directly · 0 of its ownK012026 Trident All Poly CupHowmedica Osteonics Corp. · 2001

Most influential descendants

Showing 1 of 1 · See all

K012026Trident All Poly CupHowmedica Osteonics Corp. · 2001 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001956	Trident All Poly Cup	Howmedica Osteonics Corp.	2000	—
0 (this device)	K010310	Modification to Trident All Poly Cup	Howmedica Osteonics Corp.	2001	—
+1	K012026	Trident All Poly Cup	Howmedica Osteonics Corp.	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K010310, 2000–2001Source: 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

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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
*	K001956	Trident All Poly Cup Summary page 1 …terilization of the subject device are identical to those of predicate device. The predicate device was found substantially equivalent via the 510(k) process in 510(k) #K001956. The predicate and subject devices are polyethylene acetabular components that are intended to replace the bearing portion of the…	Howmedica Osteonics Corp.	2000	—

Also cleared against K001956: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K012026	Trident All Poly Cup	Howmedica Osteonics Corp.	2001	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?

Its one ancestor has no recall.
Of its descendants, K012026 (Howmedica Osteonics Corp., 2001) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K001956.

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 Trident All Poly Cup is a polyethylene acetabular component that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is designed to be cemented into the acetabulum. These acetabular cups are intended to be used with any Howmedica Osteonics' femoral head.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K010310 · printed Nov 5, 2026

Cite this page

510(k) Report. “K010310: Modification to Trident All Poly Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010310

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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