# K071243: Metal Hemi Implant

- Pathway: 510(k) (Special)
- Applicant: Orthopro, LLC
- Decided: May 23, 2007 after 20 days
- Product code: KWD (Prosthesis, Toe, Hemi-, Phalangeal)
- Device class: 2
- Regulation: 21 CFR 888.3730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K864492 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062908: Orthropro Hemi Toe, Orthopro, LLC (2006) Summary page 1.

## Recalls of this device
- May 29, 2008 · Not classified · Z-2228-2008: Labeling presented conflicting information as to whether device was sterile or not.

## Indications for use
The Metal Hemi Implant is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.

Source page: https://510kreport.com/device/K071243
Methodology: https://510kreport.com/methodology