# K983153: Natural-Knee II Posterior Stabilized (P.S.) Condylar Knee Tibial Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Dec 4, 1998 after 86 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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 Constrained Knee Tibial Inserts: named in the summary without a submission number
- (no number) Natural-Knee® II P.S. Tibial Inserts: named in the summary without a submission number
- (no number) Apollo™ Constrained/Revision Knee Tibial Inserts: 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
- K191625: Persona Revision Knee System (2019), 1 descendant of its own
- K243724: Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (2025), 0 descendants of its own
- K210829: Persona Revision Knee System Femoral Metaphyseal Cones (2021), 0 descendants of its own

## Recalls of this device
- Feb 25, 2014 · Class II · Z-1257-2014: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a

## Indications for use
The Natural-Knee II P.S. Condylar Tibial Inserts are intended for use in the following diagnostic indications: 1. Patient conditions, including but not limited to, inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis). 2. Correctable valgus-varus deformity and moderate flexion contracture. 3. Those patients with failed previous surgery where pain, deformity, or dysfunction persist. 4. Revision of previously failed knee arthroplasty.

Source page: https://510kreport.com/device/K983153
Methodology: https://510kreport.com/methodology