510(k) · Cleared

Cleared

Advance Double High Insert

K033890510(k) SpecialCleared Jan 15, 200430-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

Wrightmedicaltechnologyinc · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jan 15, 2004 after a 30-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.

Decided: Jan 15, 2004
Review: 30 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 0

12 later devices descend from it, 4 citing it directly.

This deviceK033890 Advance Double High InsertWrightmedicaltechnologyinc · 2004
Descendant · cites it directly · 11 of its ownK102380 Evolution MP Total Knee SystemWrightmedicaltechnologyinc · 2011 · Recalled
Descendant · cites it directly · 7 of its ownK113325 Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc · 2011
Descendant · 2 generations on · 6 of its ownK131679 Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc · 2013
Descendant · 2 generations on · 5 of its ownK140735 Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc. · 2014 · Recalled
Descendant · 2 generations on · 4 of its ownK182251 EVOLUTION NitrX Medial-Pivot KneeMircoport Orthopedics, Inc. · 2019

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2011high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 12 · See all

K102380Evolution MP Total Knee SystemWrightmedicaltechnologyinc · 2011 · cites it directly11descendants
K113325Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc · 2011 · cites it directly7descendants
K131679Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc · 2013 · 2 generations on6descendants
K140735Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc. · 2014 · 2 generations on5descendants
K182251EVOLUTION NitrX Medial-Pivot KneeMircoport Orthopedics, Inc. · 2019 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K033890	Advance Double High Insert	Wrightmedicaltechnologyinc	2004	—
+1	K102380	Evolution MP Total Knee System	Wrightmedicaltechnologyinc	2011	4
+1	K113325	Evolution MP Adaptive CS Insert	Wrightmedicaltechnologyinc	2011	—
+2	K131679	Evolution MP Adaptive PS Tibial Insert	Wrightmedicaltechnologyinc	2013	—
+2	K140735	Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts	Microport Orthopedics, Inc.	2014	1
+2	K182251	EVOLUTION NitrX Medial-Pivot Knee	Mircoport Orthopedics, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2013	1	0
2014	1	0
2016	1	0
2019	1	0
2022	1	0
2024	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K033890, 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

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
*	—	ADVANCE® Medial Pivot Insert Named without a submission number			—
*	—	AXIOM® Standard Tibial Insert Named without a submission number			—

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K102380	Evolution MP Total Knee System	Wrightmedicaltechnologyinc	2011	11
K113325	Evolution MP Adaptive CS Insert	Wrightmedicaltechnologyinc	2011	7
K240043	EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…	Microport Orthopedics, Inc.	2024	0
K152631	MPO Total Knee Systems MR Labeling	Microport Orthopedics, Inc.	2016	0

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?

Of its descendants, K102380 (Wrightmedicaltechnologyinc, 2011) has gone furthest, with 11 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 ADVANCE® Double High Insert is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

2) inflammatory degenerative joint disease including rheumatoid arthritis;

3) correction of functional deformity;

4) revision procedures where other treatments or devices have failed; and

5) treatment of fractures that are unmanageable using other techniques.

The ADVANCE® Double High Insert is for single cemented use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033890 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033890: Advance Double High Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033890

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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