# K070897: Bonemedik, and Bonemedik-S

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Sep 17, 2007 after 168 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K960978 (1996). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P860005: Pro Osteon Implant 500 Hydroxyapatite Bone Void Filler, Interpore Intl. (1992) Summary page 2.
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 2.
- K980817: Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L, Interpore Intl. (1998) Summary page 2.
- K060917: Kensey Nash Bone Void Filler, Kensey Nash Corporation (2006) Summary page 2.
- K033679: Copsios Bone Void Filler (BVF), Centerpulse Spine-Tech, Inc. (2004) Summary page 2.

## Indications for use
BoneMedik and BoneMedik-S are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products provide a bone graft substitute that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K070897
Methodology: https://510kreport.com/methodology