# K051611: Mbaresorb Implant

- Pathway: 510(k) (Traditional)
- Applicant: Kinetikos Medical, Inc.
- Decided: Sep 6, 2005 after 81 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K792670 (1980). 3 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960692: Subtalar Mba System, Kinetikos Medical, Inc. (1996) Summary page 1.
- K973758: Bioscrew Absorbable Interference Srew, Linvatec Corp. (1998) Summary page 1.

## Most influential descendants
- K071456: Arthrex Prostop Plus Arthroereisis Subtalar Implant (2008), 9 descendants of its own
- K093820: Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 (2010), 8 descendants of its own
- K103183: Trilliant Surgical Subtalar Implant (2011), 4 descendants of its own
- K111834: Disco Subtalar Implant (2011), 3 descendants of its own
- K133035: Normed Pellegrin Calcaneus Stop Screw (2013), 2 descendants of its own

## Recalls of this device
- Mar 1, 2019 · Class II · Z-1089-2019: Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
- Mar 1, 2019 · Class II · Z-1090-2019: Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
- Mar 1, 2019 · Class II · Z-1091-2019: Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F

## Indications for use
The MBAResorb Implant is indicated as an internal support to primary surgical interventions in the treatment of fiat foot, providing structural support at minimum during the first three months of healing.

Source page: https://510kreport.com/device/K051611
Methodology: https://510kreport.com/methodology