# K083469: Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000

- Pathway: 510(k) (Traditional)
- Applicant: Metasurg
- Decided: Feb 13, 2009 after 81 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: 1 generation back to K023684 (2004). 2 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 15 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.

## Most influential descendants
- K102401: Hemi Implant; Mini Hemi Implant (2011), 11 descendants of its own
- 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

## Indications for use
The MetaSurg cannulated titanium hemi implant is indicated for use in the treatment of degenerative arthritis in the 1st metatarsal joint along with the following clinical conditions: Hallux Limitus or Hallux Rigidus, Hallux Valgus and pain or instability in the metatarsophalangeal joint. The MetaSurg cannulated titanium hemi implant is intended for press fit, uncemented use. The MetaSurg cannulated titanium hemi implant is intended for single use only.

Source page: https://510kreport.com/device/K083469
Methodology: https://510kreport.com/methodology