# K102401: Hemi Implant; Mini Hemi Implant

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, Inc.
- Decided: Jul 20, 2011 after 330 days
- Product code: KWD (Prosthesis, Toe, Hemi-, Phalangeal)
- Device class: 2
- Regulation: 21 CFR 888.3730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K864492 (1987). 16 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023684: Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365, Vilex, Inc. (2004) Summary page 1.
- K041595: Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870, Biopro, Inc. (2004) Summary page 1.
- K083469: Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000, Metasurg (2009). Our reading of the summary gave K084369, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Metasurg Hemi Joint”. Summary page 1.
- K081876: Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating, Osteomed LP (2008) Summary page 1.
- K971047: Futura Biomedical Metal Hemi Toe Implant, Nexa Orthopedics, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K091378: Mammosite II Radiation Therapy System, Hologic, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K131377: Hemicap MTP Resurfacing Hemi-Arthroplasty Implant (2013), 9 descendants of its own
- K152454: HemiCAP MTP Resurfacing Hemi-Arthroplasty System (2016), 6 descendants of its own
- K190543: Cannulated Hemi Implant (2019), 5 descendants of its own
- K203634: BioPoly Great Toe Hemiarthroplasty Implant (2021), 2 descendants of its own
- K222964: BioPoly Lesser Toe Hemiarthroplasty Implant (2022), 1 descendant of its own

## Indications for use
The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidlus, and an unstable or painful MTP joint. The Vilex cannulated metallic hemi implant is intended to be used with bone cement or press fit without bone cement. The Vilex cannulated metallic hemi implant is intended for single use only.

Source page: https://510kreport.com/device/K102401
Methodology: https://510kreport.com/methodology