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Modification to Solanas Posterior Stabilization System

by Alphatec Spine, Inc.

510(k) K071380

Modification to Solanas Posterior Stabilization System is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K071380 on 20 Aug 2007, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK071380 Date20 Aug 2007ClearedStatusActive

Official records

Recalls

3 recalls · FDA

    • Terminated Z-0932-2012 FDA Unclassified (pre-2012) initiated 1 Nov 2010 on shared 510(k) K071380

    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.

  • 2 recalls, same reason

    • Terminated Z-0503-2010 FDA Unclassified (pre-2012) initiated 5 Aug 2009 on shared 510(k) K071380
    • Terminated Z-0502-2010 FDA Unclassified (pre-2012) initiated 5 Aug 2009 on shared 510(k) K071380

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K071380
  2. Recall initiated FDA recalls Z-0503-2010
  3. Recall initiated FDA recalls Z-0502-2010
  4. Recall initiated FDA recalls Z-0932-2012

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NKB
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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