Norian Skeletal Repair System (SRS) Cancellous Bone Cement
PMA P970010
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP970010 | Date23 Dec 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Filler, bone void, non-osteoinduction
- PMA Number
- FDA Product Code
- MBS
- Device Class
- Class III
- Advisory Committee
- Orthopedic
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The Norian Skeletal Repair System (SRS) Cancellous Bone Cement is a non-osteoinductive bone void filler designed for orthopedic applications. It is indicated for use as an adjunct for fracture stabilization in the treatment of low impact, unstable, metaphyseal distal radius fractures where early mobilization is appropriate.
This system is intended for use in cases where a specific post-operative protocol of a cast for two weeks followed by a removable splint for two to four weeks is indicated. The use of the SRS system alone is not indicated for highly comminuted fractures. This device is authorized under FDA PMA P970010.
Other devices from Synthes (Usa)
Questions
AI-generated answers, 18 Sep 2026
What is the primary use of the Norian Skeletal Repair System?
The system is used as an adjunct for fracture stabilization specifically for low impact, unstable, metaphyseal distal radius fractures.
Is this bone cement suitable for all types of fractures?
No, the use of the SRS system alone is not indicated for highly comminuted fractures, as it is intended for specific low impact, unstable, metaphyseal distal radius fractures.
What regulatory authorization does this device hold?
The Norian Skeletal Repair System is authorized under FDA PMA (Premarket Approval) number P970010.