510(k) · Cleared

Recalled · 2010

Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZ

K040630510(k) TraditionalCleared Sep 30, 2004204-day reviewClass II21 CFR 888.3560Recalls 2

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

Implex Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Sep 30, 2004 after a 204-day review. The FDA summary names no predicate by number. 76 later devices descend from it. It has been recalled 2 times.

Decided: Sep 30, 2004
Review: 204 days
Class: Class II
Product code: JWH
Recalls: 2
Predicates: 0

76 later devices descend from it, 3 citing it directly.

This deviceK040630 Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZImplex Corp. · 2004
Descendant · cites it directly · 75 of its ownK051756 Modification to:Trabecular Metal Femoral Cone Augments, Models…Zimmer Trabecular · 2005
Descendant · 2 generations on · 74 of its ownK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
Descendant · 2 generations on · 53 of its ownK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
Descendant · 3 generations on · 40 of its ownK143393 Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · Recalled
Descendant · 4 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2005high 13 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 76 · See all

K051756Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZZimmer Trabecular · 2005 · cites it directly75descendants
K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006 · 2 generations on74descendants
K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010 · 2 generations on53descendants
K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · 3 generations on40descendants
K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 4 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K040630	Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZ	Implex Corp.	2004	—
+1	K051756	Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZ	Zimmer Trabecular	2005	—
+2	K053340	Trabecular Metal Tibial and Femoral Cone Augments	Zimmer Trabecular	2006	—
+2	K100391	Depuy Universal Gription TF Cones	DePuy Orthopaedics, Inc.	2010	—
+3	K143393	Triathlon Tritanium Cone Augments	Stryker Orthopaedics	2015	1
+4	K172326	Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System	Stryker Orthopaedics	2017	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2007	1	0
2010	1	0
2011	2	0
2012	1	0
2013	1	0
2014	2	0
2015	1	0
2016	1	0
2017	3	0
2018	7	0
2019	3	0
2020	9	0
2021	4	0
2022	3	0
2023	5	0
2024	10	0
2025	13	0
2026	7	0

FIG. 1 — Lineage of K040630, 2004–2026Source: 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 JWH? 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 JWH device

#1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 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?

The FDA summary names no predicate by number.

What descends from it? (76)

See all 76

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

Number	Device	Applicant	Decided	Descendants
K051756	Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZ	Zimmer Trabecular	2005	75
K103517	Trabecular Metal Femoral Cone Augments	Zimmer Trabecular Metal Technology, Inc.	2011	11
K181947	Persona Revision Knee System	Zimmer, Inc.	2018	4

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 5, 2010	Not classified	Z-2440-2010	Labeling mix-ups	Zimmer, Inc. has determined that there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left.
Jul 5, 2010	Not classified	Z-2439-2010	Labeling mix-ups	Zimmer, Inc. has determined that there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K051756 (Zimmer Trabecular, 2005) has gone furthest, with 75 descendants of its own.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

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

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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	18	74	14	1,305
2008	17	81	10	1,483
2009	11	168	109	1,870
2010	19	85	32	3,286
2011	25	87	27	5,133
2012	33	85	85	5,203
2013	31	128	31	6,135
2014	33	98	13	6,722
2015	27	87	11	6,881
2016	18	88	17	7,586
2017	25	118	61	12,263
2018	25	90	14	14,071
2019	28	133	5	14,987
2020	22	59	2	12,592
2021	24	61	8	9,408
2022	17	56	12	8,364
2023	20	57	67	8,947
2024	19	89	7	10,828
2025	20	55	2	9,306
2026	12	63	4	—

What is it indicated for?

The Trabecular Metal Femoral Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Femoral Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040630 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040630: Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040630

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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