# K023528: Natural-Knee II Cemented Modular Tibial Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Centerplus Orthopedics, Inc.
- Decided: Jan 17, 2003 after 88 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Natural-Knee II System CoCr Tibial Baseplate: named in the summary without a submission number
- (no number) Stryker/Osteonics/Howmedica Duracon: named in the summary without a submission number
- (no number) Stryker/Osteonics/Howmedica Scorpio: named in the summary without a submission number
- (no number) Wright Medical Advance: named in the summary without a submission number

## Most influential descendants
- K173057: Zimmer Knee Joint Replacement Prostheses MR Labeling (2018), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K143725: Consensus Knee System Modular Tibial Baseplate (2015), 3 descendants of its own
- K160515: PS2 Knee System (2016), 2 descendants of its own
- K191084: The Optimotion Blue Total Knee System (2020), 1 descendant of its own

## Recalls of this device
- Mar 18, 2009 · Not classified · Z-1485-2009: The tibial spacer will not affix to the distal surface of the baseplate, as intended.
- Mar 18, 2009 · Not classified · Z-1484-2009: The tibial spacer will not affix to the distal surface of the baseplate, as intended.
- Mar 18, 2009 · Not classified · Z-1483-2009: The tibial spacer will not affix to the distal surface of the baseplate, as intended.
- Mar 18, 2009 · Not classified · Z-1482-2009: The tibial spacer will not affix to the distal surface of the baseplate, as intended.
- Nov 25, 2008 · Not classified · Z-0871-2009: 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 an

## Indications for use
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.

Source page: https://510kreport.com/device/K023528
Methodology: https://510kreport.com/methodology