# K021578: Natural-Knee II System Cocr Tibial Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Aug 9, 2002 after 87 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
112 later devices descend from it; 1 cites it directly.
0 of 113 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 Non-porous Stemmed Tibial Baseplate: named in the summary without a submission number

## Most influential descendants
- K060192: Apex Knee System (2006), 111 descendants of its own
- K073602: Modification to: Apex Knee System (2008), 72 descendants of its own
- K080842: Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes] (2008), 61 descendants of its own
- K131353: Comprehensive Reverse Shoulder - Titanium Glenosphere (2013), 60 descendants of its own
- K112906: Klassic Knee System (2012), 33 descendants of its own

## Indications for use
The Natural-Knee II CoCr Tibial Baseplate is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following: Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); e. g., avascular necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g, rheumatoid arthritis. Correctable valgus-varus deformity and moderate flexion contracture.

Source page: https://510kreport.com/device/K021578
Methodology: https://510kreport.com/methodology