510(k) · Cleared

Recalled · 2011

Modified to Modular FR Severe Bone Loss Trauma

K002324510(k) SpecialCleared Aug 24, 200024-day reviewClass II21 CFR 888.3350Recalls 1

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

Sulzermedica · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Aug 24, 2000 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it. It has been recalled once.

Decided: Aug 24, 2000
Review: 24 days
Class: Class II
Product code: JDI
Recalls: 1
Predicates: 0

14 later devices descend from it, 1 citing it directly.

This deviceK002324 Modified to Modular FR Severe Bone Loss TraumaSulzermedica · 2000
Descendant · cites it directly · 13 of its ownK070978 Zimmer Segmental SystemZimmer, Inc. · 2007 · Recalled
Descendant · 2 generations on · 10 of its ownK110940 Zimmer Segment System Trabecular Metal Proximal Tibial Component…Zimmer, Inc. · 2011
Descendant · 3 generations on · 3 of its ownK141331 Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014
Descendant · 2 generations on · 2 of its ownK190100 USTAR II SystemUnited Orthopedic Corporation · 2019 · Recalled
Descendant · 3 generations on · 1 of its ownK183136 Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc. · 2019

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2007high 3 (2015) · low 0 (2009)2026

Most influential descendants

Showing 5 of 14 · See all

K070978Zimmer Segmental SystemZimmer, Inc. · 2007 · cites it directly13descendants
K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…Zimmer, Inc. · 2011 · 2 generations on10descendants
K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014 · 3 generations on3descendants
K190100USTAR II SystemUnited Orthopedic Corporation · 2019 · 2 generations on2descendants
K183136Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc. · 2019 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002324	Modified to Modular FR Severe Bone Loss Trauma	Sulzermedica	2000	—
+1	K070978	Zimmer Segmental System	Zimmer, Inc.	2007	6
+2	K110940	Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular…	Zimmer, Inc.	2011	—
+3	K141331	Biomet Orthopaedic Salvage System (Oss)	Biomet, Inc.	2014	—
+2	K190100	USTAR II System	United Orthopedic Corporation	2019	5
+3	K183136	Zimmer Segmental System Proximal Femoral Component	Zimmer, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2011	1	0
2014	1	0
2015	3	0
2019	2	0
2020	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K002324, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K070978	Zimmer Segmental System	Zimmer, Inc.	2007	13

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 15, 2011	Not classified	Z-0861-2012	Labeling False and Misleading	Fractured tips: Any use of force in a certain direction to the flat side of the instrument may result in fracturing of the mating geometry, creating the potential for metal debris at the surgical site.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K070978 (Zimmer, Inc., 2007) has gone furthest, with 13 descendants of its own.

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	—

https://510kreport.com/device/K002324 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002324: Modified to Modular FR Severe Bone Loss Trauma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002324

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026