Scandinavian Total Ankle Replacement System (S.T.A.R.Ankle)

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Prosthesis, ankle, uncemented, non-constrained

PMA Number

P050050 ↗

FDA Product Code

NTG

Device Class

Class III

Advisory Committee

Orthopedic

FDA Decision

APPR Approved

• Rsp Humeral Socket Insert Open recall

  Class II

  FDA 510(k) K141006 Active Cleared 5 Jun 2014

• What types of arthritis conditions is the S.T.A.R.Ankle system approved to treat?

  The S.T.A.R.Ankle is specifically approved for patients suffering from osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis. These conditions cause painful arthritic ankle joints that can be replaced with this uncemented, non-constrained prosthesis.

• Is the S.T.A.R.Ankle system reusable or intended for single-use per patient?

  The S.T.A.R.Ankle is designed for single-use per patient, as explicitly stated in the surgical instructions. It is not intended for reuse after implantation.

• What types of surgical settings is the S.T.A.R.Ankle intended for, and who performs the procedure?

  The S.T.A.R.Ankle is intended for surgical implantation by orthopedic specialists in a clinical setting. It is not designed for outpatient or non-hospital-based procedures.

• Can the S.T.A.R.Ankle system be used in patients who require MRI scans after surgery?

  No, the S.T.A.R.Ankle is explicitly not intended for MRI use. Patients who require MRI scans post-surgery should consult their surgeon about alternative imaging modalities.

• How is the S.T.A.R.Ankle system sterilized before use, and what are the storage requirements?

  Sterilization details are specified in the accompanying surgical instructions, though the data does not provide explicit sterilization methods. The system is modular and includes multiple component sizes, so storage should follow manufacturer guidelines to maintain sterility and integrity until use.