# K011897: Norian SRS Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 20, 2001 after 185 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
No predicates in its family tree.
35 later devices descend from it; 11 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler: named in the summary without a submission number
- (no number) Pro Osteon® S00R Resorbable Bone Graft Substitute: named in the summary without a submission number

## Most influential descendants
- K030554: Callos (2003), 11 descendants of its own
- K041842: Norian SRS Fast Set Putty (2004), 10 descendants of its own
- K051123: Callos Impact and Inject Bone Void Filler (2005), 9 descendants of its own
- K051603: Stryker Injectable Cement (2005), 3 descendants of its own
- K042072: Callos CMF Bone Void Filler (2004), 3 descendants of its own

## 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 intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine 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/K011897
Methodology: https://510kreport.com/methodology