510(k) · Cleared

Cleared

Active Knee Total Knee Replacement System

K093567510(k) TraditionalCleared Feb 5, 201079-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

Anova Implant Solutions, LLC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 5, 2010 as substantially equivalent to K021740 (Dj Orthopedics, LLC, 2002) after a 79-day review. Its family tree reaches back 2 generations to 1997.

Decided: Feb 5, 2010
Review: 79 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K973412 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK973412 Natural-Knee II Constrained Knee SystemSulzer Orthopedics, Inc. · 1997 · Recalled
1 generation backK021740 Total Knee Cemented, Semi-ConstrainedDj Orthopedics, LLC · 2002
This deviceK093567 Active Knee Total Knee Replacement SystemAnova Implant Solutions, LLC · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K973412	Natural-Knee II Constrained Knee System	Sulzer Orthopedics, Inc.	1997	2
−1	K021740	Total Knee Cemented, Semi-Constrained	Dj Orthopedics, LLC	2002	—
0 (this device)	K093567	Active Knee Total Knee Replacement System	Anova Implant Solutions, LLC	2010	—

FIG. 1 — Lineage of K093567, 1997–2010Source: 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? (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
*	K021740	Total Knee Cemented, Semi-Constrained Summary page 1 …tella components included in this submission have been previously cleared in K(021740. The femoral components are a design iteration of the femoral components cleared in K021 740. The Ultracongruent Plus tibial inserts included in this submission are similar to the Ultracongruent tibial inserts previously c…	Dj Orthopedics, LLC	2002	—

Also cleared against K021740: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 13 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K021740.

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. 2010, this device’s year, is highlighted.

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 Active Knee Total Knee Replacement System is indicated to be used only with bone

cement in patients suffering from the following conditions:

* Noninflarnmatory degenerative joint disease including osreoarthritis,

traumatic arthritis, or avascular necrosis.

* Inflammatory degenerative joint disease including rheumatoid arthritis.

* Correction of functional deformity such as varus, valgus, or flexion

deformities.

* Revision procedures where other treatments or devices have failed.

* Treatment of fractures that are unmanageable using other techniques.

The device is intended for single use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093567 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093567: Active Knee Total Knee Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093567

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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