# K041842: Norian SRS Fast Set Putty

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Jul 23, 2004 after 15 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: 1 generation back to K011897 (2001). 2 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 13 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) Summary page 1.
- K012589: Fast Set Putty, Synthes (Usa) (2002) Summary page 1.

## Most influential descendants
- K051603: Stryker Injectable Cement (2005), 3 descendants of its own
- K140309: Cranioplug (2014), 2 descendants of its own
- K071004: Osteocrete Bone Void Filler (2009), 2 descendants of its own
- K212991: Osteorevive (2022), 1 descendant of its own
- K181539: OSSDSIGN Cranioplug (2018), 1 descendant of its own

## Indications for use
Norian SRS Fast Set Putty is indicated only for filling bony voids or gaps that are not intrinsic to the stability of the bony structure. The putty is to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SRS Fast Set Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K041842
Methodology: https://510kreport.com/methodology