# K102722: Norian Drillable Inject, Norian Drillable Fast Set Putty

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA Products, LLC
- Decided: Jan 27, 2011 after 128 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960978 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073303: Norian Drillable, Synthes (Usa) (2008) Summary page 1.

## Recalls of this device
- Aug 10, 2017 · Class II · Z-0617-2018: The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dat
- May 11, 2016 · Class II · Z-1943-2016: DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots
- May 11, 2016 · Class II · Z-1944-2016: DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots
- May 11, 2016 · Class II · Z-1942-2016: DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots

## Indications for use
Norian Drillable Inject and Norian Drillable Fast Set Putty are intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. 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. Norian Drillable Inject and Norian Drillable Fast Set Putty can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty are intended to be placed into bony voids either before or after final fixation.

Source page: https://510kreport.com/device/K102722
Methodology: https://510kreport.com/methodology