# K051123: Callos Impact and Inject Bone Void Filler

- Pathway: 510(k) (Special)
- Applicant: Skeletal Kinetics, LLC
- Decided: Jun 3, 2005 after 31 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011897 (2001). 2 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030554: Callos, Skeletal Kinetics, LLC (2003) Summary page 1.

## Most influential descendants
- K051784: Osteovation CMF Bone Void Filler (2005), 2 descendants of its own
- K162864: OsteoVation Impact (2017), 1 descendant of its own
- K132211: Skaffold NMX Bone Void Filler (2014), 1 descendant of its own
- K112383: Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void Filler (2012), 1 descendant of its own
- K212353: DB-EZ Bone Void Filler (2021), 0 descendants of its own

## Recalls of this device
- Apr 6, 2020 · Class II · Z-2622-2020: 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-2620-2020: 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-2606-2020: 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-2623-2020: 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-2610-2020: 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-2593-2020: 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-2607-2020: 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-2592-2020: 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-2594-2020: 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-2621-2020: 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-2611-2020: 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-2181-2020: 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-2182-2020: 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-2183-2020: 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-2184-2020: 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-2180-2020: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- May 29, 2015 · Class II · Z-2209-2015: Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.

## Indications for use
Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler 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 by bone during the healing process.

Source page: https://510kreport.com/device/K051123
Methodology: https://510kreport.com/methodology