# K162864: OsteoVation Impact

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Kinetics, LLC
- Decided: Jan 13, 2017 after 92 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K873689 (1987). 18 ancestors in all.
1 later device descends 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)
- K051784: Osteovation CMF Bone Void Filler, Skeletal Kinetics, LLC (2005) Summary page 4.

## Most influential descendants
- K182742: DB-CMF (2019), 0 descendants of its own

## Recalls of this device
- Apr 6, 2020 · Class II · Z-2634-2020: 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-2597-2020: 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-2633-2020: 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-2598-2020: 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-2635-2020: 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-2599-2020: 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 3, 2020 · Class II · Z-2054-2020: Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.

## Indications for use
OsteoVation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.

Source page: https://510kreport.com/device/K162864
Methodology: https://510kreport.com/methodology