510(k) · Cleared

Recalled · Class II · 2020

Maxim Accel Knee System

K023546510(k) TraditionalCleared Jan 17, 200387-day reviewClass II21 CFR 888.3560Recalls 13

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

Biomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jan 17, 2003 as substantially equivalent to K915132 (Biomet, Inc., 1992) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1992. 305 later devices descend from it. It has been recalled 13 times.

Decided: Jan 17, 2003
Review: 87 days
Class: Class II
Product code: JWH
Recalls: 13
Predicates: 2

Its longest line of descent runs back 1 generation to K915132 (1992). 2 ancestors in all. 305 later devices descend from it, 15 citing it directly.

By dateBy generation

Root · 1 generation backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
This deviceK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003
Descendant · cites it directly · 255 of its ownK050222 Vanguard Anterior Stabilized Tibial BearingsBiomet, Inc. · 2005 · Recalled
Descendant · cites it directly · 249 of its ownK041046 Maxim Accel (Vanguard) PS+ BearingsBiomet, Inc. · 2004 · Recalled
Descendant · cites it directly · 248 of its ownK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
Descendant · 2 generations on · 119 of its ownK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
Descendant · 2 generations on · 114 of its ownK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010

Showing 5 of 305 descendants. See all descendants

Descendants cleared per year

2004high 28 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 305 · See all

K050222Vanguard Anterior Stabilized Tibial BearingsBiomet, Inc. · 2005 · cites it directly255descendants
K041046Maxim Accel (Vanguard) PS+ BearingsBiomet, Inc. · 2004 · cites it directly249descendants
K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008 · cites it directly248descendants
K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P. · 2010 · 2 generations on119descendants
K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010 · 2 generations on114descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915132	MCK Maximum Congruent Knee) Knee System	Biomet, Inc.	1992	6
0 (this device)	K023546	Maxim Accel Knee System	Biomet, Inc.	2003	—
+1	K050222	Vanguard Anterior Stabilized Tibial Bearings	Biomet, Inc.	2005	1
+1	K041046	Maxim Accel (Vanguard) PS+ Bearings	Biomet, Inc.	2004	1
+1	K080528	E-Poly Tibial Bearings	Biomet Orthopedics, Inc.	2008	—
+2	K091956	Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712	Encore Medical L.P.	2010	4
+2	K100048	E1 Antioxidant Infused Technology	Biomet Manufacturing Corp	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	4	0
2005	2	0
2006	4	0
2007	1	0
2008	3	0
2010	5	0
2011	6	0
2012	10	0
2013	16	0
2014	19	0
2015	16	0
2016	15	0
2017	11	0
2018	12	0
2019	20	0
2020	19	0
2021	26	0
2022	23	0
2023	21	0
2024	22	0
2025	28	0
2026	22	0

FIG. 1 — Lineage of K023546, 1992–2026Source: 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? (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
*	K915132	MCK Maximum Congruent Knee) Knee System Summary page 1 …ined polymerimetaVpolymer (888.3560) Device Classification: Class I1 Device Product Code: 87 JWH Substantially Equivalent Devices: MCK (K915 132); Performance (K936274) Device Description: The Maxim Accel Knee System is intended to replace the articular portions.…	Biomet, Inc.	1992	6
*	K936274	Kirschner Performance Posterior Stabilized Total Knee System Summary page 1 …r (888.3560) Device Classification: Class I1 Device Product Code: 87 JWH Substantially Equivalent Devices: MCK (K915 132); Performance (K936274) Device Description: The Maxim Accel Knee System is intended to replace the articular portions. of the knee…	Kirschner Medical Corp.	1995	—

Also cleared against K915132: 13 other devices →

What descends from it? (305)

See all 305

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

Number	Device	Applicant	Decided	Descendants
K050222	Vanguard Anterior Stabilized Tibial Bearings	Biomet, Inc.	2005	255
K041046	Maxim Accel (Vanguard) PS+ Bearings	Biomet, Inc.	2004	249
K080528	E-Poly Tibial Bearings	Biomet Orthopedics, Inc.	2008	248
K033489	Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…	Biomet, Inc.	2004	60
K060303	Vanguard PS Open Box Porous Femoral Components	Biomet Manufacturing Corp	2006	47
K113550	Vanguard Complete Knee System	Biomet Manufacturing Corp	2012	46
K042757	Vanguard SSK Knee System	Biomet, Inc.	2005	23
K053505	Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments	Biomet Manufacturing, Inc.	2006	19
K033260	Aequos	Aap Implantate AG	2004	19
K060525	Vanguard Removable Molded Poly Tibia	Biomet Manufacturing Corp	2006	16

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 17, 2020	Class II	Z-2150-2020	Process control	Potential presence of elevated endotoxin levels that exceed the specification limit
Apr 17, 2020	Class II	Z-2153-2020	Process control	Potential presence of elevated endotoxin levels that exceed the specification limit
Oct 22, 2018	Class II	Z-0495-2019	Labeling mix-ups	Label on the outer carton or the patient labels does not match label on the inner sterile packaging
Oct 22, 2018	Class II	Z-0496-2019	Labeling mix-ups	Label on the outer carton or the patient labels does not match label on the inner sterile packaging
Sep 29, 2017	Class II	Z-0673-2018	Labeling mix-ups	Knee implant components (tibial bearings) are labeled with the incorrect size.
Sep 29, 2017	Class II	Z-0674-2018	Labeling mix-ups	Knee implant components (tibial bearings) are labeled with the incorrect size.
Jan 4, 2017	Class II	Z-1115-2017	Process change control	packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.
Aug 9, 2016	Class II	Z-0111-2017	Labeling mix-ups	Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes that could occur as a…
Jul 6, 2011	Not classified	Z-2945-2011	Employee error	The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.
Apr 20, 2010	Not classified	Z-2204-2010	Process control	A knee implant labeled as left was opened and the package actually contained a right knee implant.
Feb 12, 2008	Not classified	Z-1375-2008	Packaging process control	Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result…
Feb 12, 2008	Not classified	Z-1376-2008	Packaging process control	Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result…
Aug 31, 2007	Not classified	Z-0123-2008	Packaging process control	Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.

The 5 latest of 13 recalls; the web page lists all.

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, K050222 (Biomet, Inc., 2005) has gone furthest, with 255 descendants of its own.
13 other devices also cite its predicate K915132.

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) Correction of varus, valgus, or posttraumatic deformity.

3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023546 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023546: Maxim Accel Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023546

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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