# K102601: Orthoflex Rod

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Pro, LLC
- Decided: Jan 14, 2011 after 127 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
Longest line of descent: 2 generations back to K884739 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022886: Metatarsophalangeal Flexible Stabilizing Rod System, Osteomed Corp. (2002) Summary page 1.
- K022887: Interphalangeal Flexible Stabilizing Rod System, Osteomed Corp. (2002) Summary page 1.
- K905795: Sgarlato Flexible Hinge Toe Implant, Sgarlato Laboratories, Inc. (1991) Summary page 1.
- K801094: Silastic Hammertoe Implant (Swanson-Well, Dow Corning Corp. Healthcare Industries Materials (1980) Summary page 1.

## Indications for use
The indications for the Ortholex Rod include: * Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis * Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis * Revision of a failed arthroplasty or arthrodesis

Source page: https://510kreport.com/device/K102601
Methodology: https://510kreport.com/methodology