# K100986: Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Kinetics, LLC
- Decided: Jul 20, 2010 after 102 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K990131 (1999). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082918: Mastergraft Resorbable Ceramic Granules, Medtronic Sofamor Danek (2009) Summary page 1.
- K082917: Mastergraft Resorbable Ceramic Granules, Medtronic Sofamor Danek (2009) Summary page 1.
- K051774: MBCP, Biomatlante (2006)
- K030554: Callos, Skeletal Kinetics, LLC (2003) Summary page 1.
- K051123: Callos Impact and Inject Bone Void Filler, Skeletal Kinetics, LLC (2005) Summary page 2.

## Recalls of this device
- Apr 6, 2020 · Class II · Z-2596-2020: 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-2612-2020: 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-2613-2020: 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-2625-2020: 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-2595-2020: 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-2626-2020: 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-2608-2020: 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-2624-2020: 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-2609-2020: 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 2, 2020 · Class II · Z-2186-2020: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- Apr 2, 2020 · Class II · Z-2185-2020: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

## Indications for use
Callos Bone Void Filler is indicated to the following indications: 1 To fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis) not intrinsic to the stability of the bony structure. These defects may be suigically created osseous defects or osseous defects created from traumatic injury to the bone. 2. To be used with autograft as a bone graft extender (i e extremities, and pelvis only). Callos resoibs and is replaced by bone during the healing process.

Source page: https://510kreport.com/device/K100986
Methodology: https://510kreport.com/methodology