Solanas Posterior Stabilization System
by Alphatec Spine, Inc. 2 variants
510(k) K052201
Solanas Posterior Stabilization System is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K052201 on 10 Nov 2005, active as of 22 Oct 2026. 3 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052201 | Date10 Nov 2005 | StatusActive |
Official records
- FDA 510(k) database K052201
Recalls
-
- Terminated Z-0932-2012
These lots were not manufactured correctly in that the instrument does not have the durability required to repeatedly perform over its full service life and, therefore, may experience breakage in the tips.
-
- Terminated Z-0503-2010
- Terminated Z-0502-2010
Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.
Timeline
- Cleared FDA 510(k) K052201
- Recall initiated FDA recalls Z-0503-2010
- Recall initiated FDA recalls Z-0502-2010
- Recall initiated FDA recalls Z-0932-2012
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent