# K031183: Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Centerpulse Orthopedics, Inc.
- Decided: Jul 14, 2003 after 90 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.
14 later devices descend from it; 2 cite it directly.
0 of 15 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) Centerpulse Orthopedics Natural-Knee System Tibial Spacer: named in the summary without a submission number

## Most influential descendants
- K094017: Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 (2010), 7 descendants of its own
- K101994: Apex Knee Modular  Tibia System (2010), 6 descendants of its own
- K173057: Zimmer Knee Joint Replacement Prostheses MR Labeling (2018), 5 descendants of its own
- K131472: Apex Knee Modular Tibia System (2013), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own

## Indications for use
The tibial spacer 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. Those patients with failed previous surgery where pain, deformity, or dysfunction persists.

Source page: https://510kreport.com/device/K031183
Methodology: https://510kreport.com/methodology