510(k) · Cleared

Recalled · 2005

TC-Plus Solution Knee

K000666510(k) TraditionalCleared Oct 13, 2000228-day reviewClass II21 CFR 888.3560Recalls 9

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

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

Cleared on Oct 13, 2000 as substantially equivalent to K923277 (Encore Orthopedics, Inc., 1993) after a 228-day review. Its family tree reaches back 1 generation to 1993. 115 later devices descend from it. It has been recalled 9 times.

Decided: Oct 13, 2000
Review: 228 days
Class: Class II
Product code: JWH
Recalls: 9
Predicates: 1

Its longest line of descent runs back 1 generation to K923277 (1993). 115 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK923277 Foundation Knee SystemEncore Orthopedics, Inc. · 1993 · Recalled
This deviceK000666 TC-Plus Solution KneePlus Orthopedics · 2000
Descendant · cites it directly · 70 of its ownK022204 VKS Knee SystemPlus Orthopedics · 2002 · Recalled
Descendant · cites it directly · 54 of its ownK011258 TC-Plus Porous Femoral ComponentsPlus Orthopedics · 2001
Descendant · cites it directly · 53 of its ownK072858 TC-Plus Primary Knee SystemSmith & Nephew, Inc. · 2007 · Recalled
Descendant · 2 generations on · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
Descendant · cites it directly · 42 of its ownK090705 Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · Recalled

Showing 5 of 115 descendants. See all descendants

Descendants cleared per year

2001high 16 (2021) · low 0 (2004)2026

Most influential descendants

Showing 5 of 115 · See all

K022204VKS Knee SystemPlus Orthopedics · 2002 · cites it directly70descendants
K011258TC-Plus Porous Femoral ComponentsPlus Orthopedics · 2001 · cites it directly54descendants
K072858TC-Plus Primary Knee SystemSmith & Nephew, Inc. · 2007 · cites it directly53descendants
K090988GMK Total Knee SystemMedacta International S.A. · 2009 · 2 generations on52descendants
K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · cites it directly42descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923277	Foundation Knee System	Encore Orthopedics, Inc.	1993	4
0 (this device)	K000666	TC-Plus Solution Knee	Plus Orthopedics	2000	—
+1	K022204	VKS Knee System	Plus Orthopedics	2002	4
+1	K011258	TC-Plus Porous Femoral Components	Plus Orthopedics	2001	—
+1	K072858	TC-Plus Primary Knee System	Smith & Nephew, Inc.	2007	15
+2	K090988	GMK Total Knee System	Medacta International S.A.	2009	1
+1	K090705	Balanced Knee System Ultracongruent Tibial Insert	Ortho Development Corp.	2009	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2003	1	0
2006	2	0
2007	1	0
2009	2	0
2010	2	0
2011	2	0
2012	7	0
2013	4	0
2014	4	0
2015	6	0
2016	4	0
2017	4	0
2018	3	0
2019	4	0
2020	8	0
2021	16	0
2022	7	0
2023	13	0
2024	4	0
2025	10	0
2026	8	0

FIG. 1 — Lineage of K000666, 1993–2026Source: 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
*	K923277	Foundation Knee System Summary page 1 …onname: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Equivalence: Encore FoundationKnee System (K923277, SE date 02/09/93) Characteristics: The TC-PLUSmSolution is a tri-compartmental total knee prosthesis…	Encore Orthopedics, Inc.	1993	4

Also cleared against K923277: 10 other devices →

What descends from it? (115)

See all 115

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

Number	Device	Applicant	Decided	Descendants
K022204	VKS Knee System	Plus Orthopedics	2002	70
K011258	TC-Plus Porous Femoral Components	Plus Orthopedics	2001	54
K072858	TC-Plus Primary Knee System	Smith & Nephew, Inc.	2007	53
K090705	Balanced Knee System Ultracongruent Tibial Insert	Ortho Development Corp.	2009	42
K023416	Modification to VKS Knee System	Plus Orthopedics	2002	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 3, 2005	Not classified	Z-0013-06	Other	Did not meet specifications.
Aug 3, 2005	Not classified	Z-0015-06	Other	Did not meet specifications.
Aug 3, 2005	Not classified	Z-0016-06	Other	Did not meet specifications.
Aug 3, 2005	Not classified	Z-0017-06	Other	Did not meet specifications.
Aug 3, 2005	Not classified	Z-0014-06	Other	Did not meet specifications.
Aug 3, 2005	Not classified	Z-0018-06	Other	Did not meet specifications.
Aug 3, 2005	Not classified	Z-0019-06	Other	Did not meet specifications.
Feb 22, 2005	Not classified	Z-0126-06	Other	Labeling discrepancy.
Apr 17, 2003	Not classified	Z-0017-04	Other	Labeling/packaging mix-up.

The 5 latest of 9 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K022204 (Plus Orthopedics, 2002) has gone furthest, with 70 descendants of its own.
10 other devices also cite its predicate K923277.

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 TC-PLUS" Solution Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for degenerative, post-traumatic or rheumatoid arthritis, avascular necrosis of-the --femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patOlectomy; moderate varus, vaigus or flexure deformity and to correct earlier unsuccessful attempts at surgery.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K000666 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000666: TC-Plus Solution Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000666

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026