510(k) · Cleared

Recalled · 2009

Natural-Knee II Cemented Modular Tibial Baseplate

K023528510(k) TraditionalCleared Jan 17, 200388-day reviewClass II21 CFR 888.3560Recalls 5

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

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

Cleared on Jan 17, 2003 after an 88-day review. The FDA summary names its predicate without a number. 10 later devices descend from it. It has been recalled 5 times.

Decided: Jan 17, 2003
Review: 88 days
Class: Class II
Product code: JWH
Recalls: 5
Predicates: 0

10 later devices descend from it, 3 citing it directly.

This deviceK023528 Natural-Knee II Cemented Modular Tibial BaseplateCenterplus Orthopedics, Inc. · 2003
Descendant · cites it directly · 5 of its ownK173057 Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · Recalled
Descendant · cites it directly · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
Descendant · cites it directly · 3 of its ownK143725 Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc. · 2015
Descendant · 2 generations on · 2 of its ownK160515 PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
Descendant · 3 generations on · 1 of its ownK191084 The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2015high 2 (2018) · low 0 (2017)2026

Most influential descendants

Showing 5 of 10 · See all

K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · cites it directly5descendants
K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · cites it directly4descendants
K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc. · 2015 · cites it directly3descendants
K160515PS2 Knee SystemConsensus Orthopedics, Inc. · 2016 · 2 generations on2descendants
K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K023528	Natural-Knee II Cemented Modular Tibial Baseplate	Centerplus Orthopedics, Inc.	2003	—
+1	K173057	Zimmer Knee Joint Replacement Prostheses MR Labeling	Zimmer, Inc.	2018	2
+1	K181947	Persona Revision Knee System	Zimmer, Inc.	2018	1
+1	K143725	Consensus Knee System Modular Tibial Baseplate	Consensus Orthopedics, Inc.	2015	—
+2	K160515	PS2 Knee System	Consensus Orthopedics, Inc.	2016	—
+3	K191084	The Optimotion Blue Total Knee System	Optimotion Implants, LLC	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2016	1	0
2018	2	0
2019	1	0
2020	1	0
2021	2	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K023528, 2003–2025Source: 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? (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	Recalls
*	—	Natural-Knee II System CoCr Tibial Baseplate Named without a submission number	—
*	—	Stryker/Osteonics/Howmedica Duracon Named without a submission number	—
*	—	Stryker/Osteonics/Howmedica Scorpio Named without a submission number	—
*	—	Wright Medical Advance Named without a submission number	—

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K173057	Zimmer Knee Joint Replacement Prostheses MR Labeling	Zimmer, Inc.	2018	5
K181947	Persona Revision Knee System	Zimmer, Inc.	2018	4
K143725	Consensus Knee System Modular Tibial Baseplate	Consensus Orthopedics, Inc.	2015	3

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 18, 2009	Not classified	Z-1485-2009	Nonconforming Material/Component	The tibial spacer will not affix to the distal surface of the baseplate, as intended.
Mar 18, 2009	Not classified	Z-1484-2009	Nonconforming Material/Component	The tibial spacer will not affix to the distal surface of the baseplate, as intended.
Mar 18, 2009	Not classified	Z-1483-2009	Nonconforming Material/Component	The tibial spacer will not affix to the distal surface of the baseplate, as intended.
Mar 18, 2009	Not classified	Z-1482-2009	Nonconforming Material/Component	The tibial spacer will not affix to the distal surface of the baseplate, as intended.
Nov 25, 2008	Not classified	Z-0871-2009	Packaging process control	Sterility compromised: Lack of assurance of sterility, as a corner flap of the sterile barrier packaging on the inner cavity may be trapped in the seal of the barrier packaging for the outer cavity and the seal integrity of the outer…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K173057 (Zimmer, Inc., 2018) has gone furthest, with 5 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 Natural-Knee II Cemented Modular Tibial Baseplate is intended for cemented use only in total knee arthroplasty for treatment of the following conditions:

1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e. g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.

2. Correctable valgus-varus deformity and moderate flexion contracture.

3. Those patients with failed previous surgery where pain, deformity or dysfunction persists.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023528 · printed Nov 5, 2026

Cite this page

510(k) Report. “K023528: Natural-Knee II Cemented Modular Tibial Baseplate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023528

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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