510(k) · Cleared

Cleared

Titanium Femoral Knee Components (Maxim and Agc)

K041466510(k) SpecialCleared Jul 1, 200429-day reviewClass II21 CFR 888.3560

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

Biomet Manufacturing Corp · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jul 1, 2004 as substantially equivalent to K981996 (Biomet, Inc., 1999) after a 29-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.

Decided: Jul 1, 2004
Review: 29 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K981996 (1999). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK981996 Titanium Femoral ComponentBiomet, Inc. · 1999
This deviceK041466 Titanium Femoral Knee Components (Maxim and Agc)Biomet Manufacturing Corp · 2004
Descendant · cites it directly · 2 of its ownK063515 Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci…Biomet Manufacturing, Inc. · 2007
Descendant · 2 generations on · 1 of its ownK203341 ACS LD Uni FB Knee SystemImplantcast GmbH · 2021
Descendant · 3 generations on · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026

Most influential descendants

Showing 3 of 3 · See all

K063515Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar KneeBiomet Manufacturing, Inc. · 2007 · cites it directly2descendants
K203341ACS LD Uni FB Knee SystemImplantcast GmbH · 2021 · 2 generations on1descendant
K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K981996	Titanium Femoral Component	Biomet, Inc.	1999	—
0 (this device)	K041466	Titanium Femoral Knee Components (Maxim and Agc)	Biomet Manufacturing Corp	2004	—
+1	K063515	Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II…	Biomet Manufacturing, Inc.	2007	—
+2	K203341	ACS LD Uni FB Knee System	Implantcast GmbH	2021	—
+3	K260037	implantcast Packaging System Update	Implantcast GmbH	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2021	1	0
2026	1	0

FIG. 1 — Lineage of K041466, 1999–2026Source: 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

Get a 510(k) Report

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
*	K981996	Titanium Femoral Component Summary page 1 …(574) 267-6639 Proprietary Name: Titanium Femoral Knee Components (Maxim®D and AGC®o) Common Name: Knee Femoral Components (K981996) Classification Name: Cemented semi-constrained polymer/metal/polymer knee prosthesis (888.3560) Substantially Equivalent Device…	Biomet, Inc.	1999	—

Also cleared against K981996: 2 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K063515	Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar Knee	Biomet Manufacturing, Inc.	2007	2

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, K063515 (Biomet Manufacturing, Inc., 2007) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K981996.

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?

1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved,

2) Failure of previous joint replacement procedure,

3) Correction of varus, valgus, or posttraumatic deformity.

4) Correction or revision of unsuccessful osteotomy or Arthrodesis

* Device designed for use in patients with metal sensitivity.

* Standard surgical and rehabilitative procedures are indicated with this device.

* The device is a single use device intended for use with bone cement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041466 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041466: Titanium Femoral Knee Components (Maxim and Agc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041466

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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