# K073303: Norian Drillable

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 2, 2008 after 222 days
- Product code: OIS (Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960978 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041842: Norian SRS Fast Set Putty, Synthes (Usa) (2004) Summary page 1.
- K030288: Polygraft Bone Graft Substitute, Osteobiologics, Inc. (2003) Summary page 1.
- K024336: Miig II Bone Graft Substitute, Wrightmedicaltechnologyinc (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K011897: Norian SRS Bone Void Filler, Synthes (Usa) (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K102722: Norian Drillable Inject, Norian Drillable Fast Set Putty (2011), 0 descendants of its own

## Recalls of this device
- Aug 10, 2017 · Class II · Z-0618-2018: 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

## Indications for use
Norian Drillable Bone Void Filler and Norian Drillable Fast Set PuttyTM 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 Bone Void Filler and Norian Drillable Fast Set PuttyTM can be used as an adjunct to conventional rigid hardware fixation by supporting bone fragments during the surgical procedure. Once the material is set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Bone Void Filler and Norian Drillable Fast Set PuttyTM are intended to be placed into bony voids either before or after final fixation.

Source page: https://510kreport.com/device/K073303
Methodology: https://510kreport.com/methodology