# K051784: Osteovation CMF Bone Void Filler

- Pathway: 510(k) (Special)
- Applicant: Skeletal Kinetics, LLC
- Decided: Jul 20, 2005 after 19 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K873689 (1987). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051123: Callos Impact and Inject Bone Void Filler, Skeletal Kinetics, LLC (2005) Summary page 1.
- K042072: Callos CMF Bone Void Filler, Skeletal Kinetics, LLC (2004) Summary page 1.

## Most influential descendants
- K162864: OsteoVation Impact (2017), 1 descendant of its own
- K182742: DB-CMF (2019), 0 descendants of its own

## Recalls of this device
- Apr 6, 2020 · Class II · Z-2619-2020: 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-2616-2020: 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-2617-2020: 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-2614-2020: 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-2615-2020: 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-2618-2020: 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-2187-2020: 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-2189-2020: 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-2188-2020: 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-2190-2020: 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-2191-2020: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- Jun 6, 2019 · Class II · Z-0867-2021: A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
- Jun 6, 2019 · Class II · Z-0866-2021: A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.

## Indications for use
OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm 2. OsteoVation CMF Bone Void Filler may be used in tile restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.

Source page: https://510kreport.com/device/K051784
Methodology: https://510kreport.com/methodology