510(k) · Cleared

Cleared

Aequos

K033260510(k) TraditionalCleared Dec 7, 2004425-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

Aap Implantate AG · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Dec 7, 2004 as substantially equivalent to K000978 (Biomet, Inc., 2000) and 3 other predicates after a 425-day review. Its family tree reaches back 4 generations to 1992. 19 later devices descend from it.

Decided: Dec 7, 2004
Review: 425 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K915192 (1992). 18 ancestors in all, the oldest K915132 (1992). 19 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
3 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
2 generations backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
1 generation backK023788 Columbus (CR) Total Knee SystemAesculap, Inc. · 2002
This deviceK033260 AequosAap Implantate AG · 2004
Descendant · cites it directly · 18 of its ownK141934 Physica KR Knee SystemLima Corporate S.P.A. · 2015
Descendant · 2 generations on · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
Descendant · 2 generations on · 8 of its ownK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015
Descendant · 3 generations on · 7 of its ownK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
Descendant · 2 generations on · 7 of its ownK152008 Physica PS Knee SystemLima Corporate S.P.A. · 2015

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2015high 3 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 19 · See all

K141934Physica KR Knee SystemLima Corporate S.P.A. · 2015 · cites it directly18descendants
K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · 2 generations on8descendants
K151266Physica CR Knee SystemLima Corporate S.P.A. · 2015 · 2 generations on8descendants
K220792SMR Reverse LinerLima Corporate S.P.A. · 2022 · 3 generations on7descendants
K152008Physica PS Knee SystemLima Corporate S.P.A. · 2015 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K915192	7000 Series Modular Tibial Components	Osteonics Corp.	1992	—
−3	K994128	Scorpio Total Stablizer (TS) Total Knee System	Howmedica Osteonics Corp.	2000	8
−2	K021313	Search Evolution Total Knee System	Aesculap, Inc.	2002	—
−1	K023788	Columbus (CR) Total Knee System	Aesculap, Inc.	2002	—
0 (this device)	K033260	Aequos	Aap Implantate AG	2004	—
+1	K141934	Physica KR Knee System	Lima Corporate S.P.A.	2015	—
+2	K190911	Physica KR Liner and SMR Reverse Humeral Liner	Limacorporate	2019	—
+2	K151266	Physica CR Knee System	Lima Corporate S.P.A.	2015	—
+3	K220792	SMR Reverse Liner	Lima Corporate S.P.A.	2022	—
+2	K152008	Physica PS Knee System	Lima Corporate S.P.A.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	2	0
1993	1	0
1995	1	0
1996	2	0
1998	3	0
2000	2	0
2001	1	0
2003	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	3	0
2019	1	0
2020	2	0
2021	3	0
2022	2	0
2023	2	0
2024	2	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K033260, 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? (4)

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
*	K000978	Anatomic Total Knee Prosthesis Summary page 2 …HMWPE) d) Tibial spacers Predicate Devices for Substantial Equivalence: /EQUOS is similar in size, material and intended use to the * Anatomic Total Knee (k000978) of Biomet, Inc. * Columbus (CR) Total Knee System (k023788) of Aesculap, Inc. * Nexgen Complete Knee Solution -…	Biomet, Inc.	2000	—
*	K023788	Columbus (CR) Total Knee System Summary page 2 …uivalence: /EQUOS is similar in size, material and intended use to the * Anatomic Total Knee (k000978) of Biomet, Inc. * Columbus (CR) Total Knee System (k023788) of Aesculap, Inc. * Nexgen Complete Knee Solution - Trabecular Metal (k024161) of Implex Corp. * Maxim…	Aesculap, Inc.	2002	—
*	K024161	Nexgen Complete Knee Solution - Trabecular Metal Augments Summary page 2 …ic Total Knee (k000978) of Biomet, Inc. * Columbus (CR) Total Knee System (k023788) of Aesculap, Inc. * Nexgen Complete Knee Solution - Trabecular Metal (k024161) of Implex Corp. * Maxim Accel Knee System (kO23546) of Biomet, Inc. Comparision of Technological Characteris…	Implex Corp.	2003	2
*	K023546	Maxim Accel Knee System	Biomet, Inc.	2003	13

Also cleared against K000978: 1 other device →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K141934	Physica KR Knee System	Lima Corporate S.P.A.	2015	18

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?

The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
8 of the 18 ancestors have a recall of any class.
Of its descendants, K141934 (Lima Corporate S.P.A., 2015) has gone furthest, with 18 descendants of its own.
1 other device also cites its predicate K000978.

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?

Damaged and seriously damaged and painful knee joints with relevant malfunction, instability or subluxation of the joint

Therapy resistant bow contracture of more than 200 or non compensable malposition of the anatomical axis from approximatly 15-20°

Double sided joint anchylosis or anchylosis of the opposite hip joint

All conservative therapies were unsuccessful or joint conserving operations provide no success or have already failed

Failure after implantation of monocondylar implants

Stiffening of the joint is contraindicated

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033260 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033260: Aequos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033260

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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