# K060408: Norian SRS Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 21, 2006 after 33 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011897 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011897: Norian SRS Bone Void Filler, Synthes (Usa) (2001)

## Recalls of this device
- Sep 29, 2011 · Not classified · Z-0460-2012: A recent shipment carrying Norian SRS was lost by the carrier. Since the product was lost before final product release testing, Synthes is unable to confirm that Part Number SRS-005-FSP- Lot Number N0

## Indications for use
Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is inteided to be placed or injected into bony voids or gaps of the skeletal system (the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K060408
Methodology: https://510kreport.com/methodology