# K022887: Interphalangeal Flexible Stabilizing Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Nov 26, 2002 after 88 days
- Product code: KWH (Prosthesis, Toe, Constrained, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Sgarlato Laboratories Shaw-Ship Rod, Hammer Toe Implant: named in the summary without a submission number

## Most influential descendants
- K102601: Orthoflex Rod (2011), 0 descendants of its own

## Indications for use
Indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; angular deformity; impaired function and stability; pain; impaired toe length ratio. Implants are single use only.

Source page: https://510kreport.com/device/K022887
Methodology: https://510kreport.com/methodology