# K112383: Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Kinetics, LLC
- Decided: Feb 7, 2012 after 173 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- 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: 3 generations back to K011897 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060011: Miig SR, Wrightmedicaltechnologyinc (2006) Summary page 1.
- K070437: Pro-Dense Bone Void Filler, Wrightmedicaltechnologyinc (2007) Summary page 1.
- K051123: Callos Impact and Inject Bone Void Filler, Skeletal Kinetics, LLC (2005) Summary page 1.

## Most influential descendants
- K210193: DB-Composite (2021), 0 descendants of its own

## Recalls of this device
- Apr 6, 2020 · Class II · Z-2630-2020: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-te
- Apr 6, 2020 · Class II · Z-2636-2020: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-te
- Apr 6, 2020 · Class II · Z-2631-2020: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-te

## Indications for use
Callos® ProModel Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos ProModel is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K112383
Methodology: https://510kreport.com/methodology