# K041595: Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Nov 12, 2004 after 151 days
- Product code: KWD (Prosthesis, Toe, Hemi-, Phalangeal)
- Device class: 2
- Regulation: 21 CFR 888.3730
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 7 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060536: Osteomed 1ST MPJ Hemi Implant System (2006), 16 descendants of its own
- K073065: Osteomed Metatarsal Resurfacing Implant System (2008), 15 descendants of its own
- K081876: Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating (2008), 13 descendants of its own
- K083469: Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000 (2009), 12 descendants of its own
- K102401: Hemi Implant; Mini Hemi Implant (2011), 11 descendants of its own

## Recalls of this device
- Feb 1, 2022 · Class II · Z-0686-2022: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Imp
- Feb 1, 2022 · Class II · Z-0684-2022: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Imp
- Feb 1, 2022 · Class II · Z-0685-2022: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Imp
- Feb 1, 2022 · Class II · Z-0690-2022: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Imp
- Feb 1, 2022 · Class II · Z-0682-2022: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Imp
- Feb 1, 2022 · Class II · Z-0683-2022: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Imp
- Feb 1, 2022 · Class II · Z-0687-2022: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Imp
- Feb 1, 2022 · Class II · Z-0688-2022: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Imp
- Feb 1, 2022 · Class II · Z-0689-2022: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Imp
- Feb 1, 2022 · Class II · Z-0691-2022: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Imp

## Indications for use
A) A press fit implant for arthritic degradation of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of the normal ambulatory function of the forefoot. B) Degenerative arthritis C) Rheumetoid arthritis D) Bunion deformity associated with arthritis of the metatarsal-phalangeal joint E) The titanium version is available for use only in patients susceptible to nickel chromium allergies.

Source page: https://510kreport.com/device/K041595
Methodology: https://510kreport.com/methodology