# K991052: FS 1000 Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Renaissance Instruments, LLC
- Decided: Nov 10, 1999 after 225 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.
23 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K121416: GMK Sphere (2012), 20 descendants of its own
- K140826: GMK Sphere Extension (2014), 17 descendants of its own
- K162035: GMK Sphere (2017), 10 descendants of its own
- K173890: GMK Sphere - Kinematic Alignment (2018), 6 descendants of its own
- K211004: GMK Spherika Femurs and Fixed Tibial Trays Plus (2021), 4 descendants of its own

## Indications for use
The FS 1000 Knee System is intended for single-use cemented implantation for use in total knee arthroplasty surgery for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or avascular necrosis; Inflammatory degenerative joint disease including rheumatoid arthritis; Correction of varus, valgus, or post traumatic deformity; Correction or revision of unsuccessful osteotomy or arthrodesis; Revision procedures where other treatments or devices have failed; and Treatment of fractures that are unmanageable using other techniques;

Source page: https://510kreport.com/device/K991052
Methodology: https://510kreport.com/methodology