# K992287: First Step Unicompartmental Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 16, 1999 after 132 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
122 later devices descend from it; 4 cite it directly.
0 of 123 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) Duracon Unicompartmental Knee: named in the summary without a submission number
- (no number) SCR Uni Knee Systems: named in the summary without a submission number

## Most influential descendants
- K033769: Eius Unicompartmental Knee System (2004), 121 descendants of its own
- K043570: Unicondylar Knee Repair System / Conformis Ucd (2005), 62 descendants of its own
- K080368: Mako Surgical Corp. Unicondylar Knee Implant System II (2008), 56 descendants of its own
- K082172: Mako Modular Knee Compartmental Implant System (2008), 51 descendants of its own
- K090763: Restoris Multicompartmental Knee (MCK) System (2009), 50 descendants of its own

## Indications for use
The First Step Unicompartmental Knee System consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. The subject components of the First Step Unicompartmental Knee System are single use devices which are sold sterile. The First Step Unicompartmental Knee System is intended for cemented use only. The specific indications and contraindications of the First Step Unicompartmental Knee System are stated in the following sections. Indications Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis. Revision of previous unsuccessful unicompartmental knee replacement or other procedure. As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

Source page: https://510kreport.com/device/K992287
Methodology: https://510kreport.com/methodology