Premier-Total Hip with Calcitite Coating

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

Full name

Premier-Total(Tm) Hip with Calcitite(R) Coating

510(k) Number

K910755 ↗

FDA Product Code

MEH

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Drg Cemeted Stem

  Class II

  FDA 510(k) K920003 Active Cleared 13 Mar 1992

• Intermedics Power Broach Impactor

  Class I

  FDA 510(k) K895121 Active Cleared 11 Sep 1989

• Intermedics High Tibial Osteotomy System

  Class II

  FDA 510(k) K892228 Active Cleared 6 Oct 1989

• Ioi Bipolar Prosthesis

  Class II

  FDA 510(k) K873815 Active Cleared 28 Oct 1987

• Select(R) Shoulder All Poly Glenoid

  Class II

  FDA 510(k) K935802 Active Cleared 22 May 1995

• Zweymueller Sl Femoral Hip Stem

  Class II

  FDA 510(k) K962101 Active Cleared 19 Aug 1996

See all devices from Intermedics Orthopedics →

• What is the Premier-Total Hip with Calcitite Coating used for?

  This device is designed for surgical implantation to replace a damaged or diseased hip joint, restoring function and relieving pain in patients with degenerative joint conditions. The Calcitite coating helps improve bone integration, ensuring better long-term stability within the femoral bone.

• How is the Premier-Total Hip with Calcitite Coating supplied and intended for use?

  The device is supplied sterile and intended exclusively for single-use in orthopedic surgical settings. It is not meant for reuse or reprocessing, adhering to standard sterile surgical instrument protocols to maintain safety and efficacy.

• Is the Premier-Total Hip with Calcitite Coating reusable or single-use?

  This device is strictly for single-use only. Its sterile packaging and design ensure optimal performance and safety during a single surgical procedure, preventing contamination or degradation from repeated use.

• What storage and handling precautions should be followed for this device?

  The Premier-Total Hip with Calcitite Coating must be stored and handled according to sterile surgical instrument protocols to preserve its sterility. Always follow the manufacturer’s guidelines for storage conditions and expiration dates to ensure device integrity.

• Does this device have any specific MRI safety considerations?

  Yes, MRI safety considerations apply to this device. Before imaging, clinicians must consult the manufacturer’s specifications to determine compatibility and safety protocols for MRI procedures, as certain materials may interact with magnetic fields.