510(k) · Decided
Recalled · Class II · 2017Norian Drillable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · OIS Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
Cleared on Jul 2, 2008 as substantially equivalent to K041842 (Synthes (Usa), 2004) and 2 other predicates after a 222-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jul 2, 2008
- Review
- 222 days
- Class
- Class II
- Product code
- OIS
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 3 generations to K960978 (1996). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 1 generation backK030288 Polygraft Bone Graft SubstituteOsteobiologics, Inc. · 2003
- This deviceK073303 Norian DrillableSynthes (Usa) · 2008
- Descendant · cites it directly · 0 of its ownK102722 Norian Drillable Inject, Norian Drillable Fast Set PuttySynthes USA Products, LLC · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K102722Norian Drillable Inject, Norian Drillable Fast Set PuttySynthes USA Products, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −2 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −1 | K030288 | Polygraft Bone Graft Substitute | Osteobiologics, Inc. | 2003 | — |
| 0 (this device) | K073303 | Norian Drillable | Synthes (Usa) | 2008 | — |
| +1 | K102722 | Norian Drillable Inject, Norian Drillable Fast Set Putty | Synthes USA Products, LLC | 2011 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K011897 | FDA’s K011897 is Norian SRS Bone Void Filler Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K041842 | Norian SRS Fast Set PuttySummary page 1…ne void, calcium compounds.- Product Codes MQV, 015 Predicate Devices Norian SRS Bone Void Filler (KG 11897) Norian SRS FastSet PUttyTM (K04 1842) Osteobiologics PolygraftT mt Bone Graft Substitute (K030288) Wright Medical MIIG II Bo… | 2004 |
| * | K030288 | Polygraft Bone Graft SubstituteSummary page 1…orian SRS Bone Void Filler (KG 11897) Norian SRS FastSet PUttyTM (K04 1842) Osteobiologics PolygraftT mt Bone Graft Substitute (K030288) Wright Medical MIIG II Bone Graft Substitute (K024336) Device Norian Drillable Bone Void Fil… | 2003 |
| * | K024336 | Miig II Bone Graft SubstituteSummary page 1…t PUttyTM (K04 1842) Osteobiologics PolygraftT mt Bone Graft Substitute (K030288) Wright Medical MIIG II Bone Graft Substitute (K024336) Device Norian Drillable Bone Void Filler and Norian Drillable FastSet Description: PutiyTrm are moldable,… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102722 | Norian Drillable Inject, Norian Drillable Fast Set Putty | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2017 | Class II | Z-0618-2018 | Process control | 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 dates were later than the earliest… |
| May 11, 2016 | Class II | Z-1943-2016 | Under Investigation by firm | 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 and associated part numbers may… |
| May 11, 2016 | Class II | Z-1944-2016 | Under Investigation by firm | 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 and associated part numbers may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K102722 (Synthes USA Products, LLC, 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K041842.
How does its category compare?
All OIS devicesOIS Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OIS
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · OIS
Too few OIS 510(k)s in any year since 2007 to give a median.
Recalls per year · OIS
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OIS
2in 2013
MAUDE reports naming product code OIS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (148 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073303 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073303: Norian Drillable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073303
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026