Osteonics 6011 Hip Stem Series

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

Full name

Osteonics(R) 6011 Hip Stem Series

510(k) Number

K905158 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SN

• Osteonics(R) Omnifit(R) Normalized Hip Stem

  Class II

  FDA 510(k) K932519 Active Cleared 10 Mar 1994

• Omnifit II Hip Prostheses: Cement Fixation

  Class II

  FDA 510(k) K870235 Active Cleared 29 May 1987

• Osteonics Total Elbow System Open recall

  Class II

  FDA 510(k) K980502 Active Cleared 5 May 1998

• MC2P Acetabular Component Open recall

  Class II

  FDA 510(k) K900438 Active Cleared 18 Apr 1990

• Shoulder Microstructured Humeral Prosthesis

  Class II

  FDA 510(k) K883816 Active Cleared 10 Nov 1988

• Osteonics(R) Mpss Hip Stem Series

  Class II

  FDA 510(k) K905275 Active Cleared 28 Jan 1991

See all devices from Osteonics Corp. →

• What is the Osteonics 6011 Hip Stem Series used for?

  The Osteonics 6011 Hip Stem Series is designed as a femoral component for total hip arthroplasty. It replaces the natural femoral head and neck with a metal stem and polymer liner, secured in place using bone cement. The semi-constrained design allows for controlled movement between the stem and acetabular component, helping to reduce the risk of dislocation while accommodating varying degrees of joint motion.

• How is the Osteonics 6011 Hip Stem Series supplied and prepared for use?

  This device is supplied as a cemented implant, meaning it requires surgical placement by an orthopedic specialist in a controlled operating room environment. The stem and polymer liner are provided separately, and bone cement is used to secure the implant during surgery. Sterile handling is mandatory prior to implantation, as it is intended for single-use only.

• Is the Osteonics 6011 Hip Stem Series reusable or single-use?

  The Osteonics 6011 Hip Stem Series is explicitly intended for single-use only. After surgical implantation, the device should not be reused or reprocessed for another patient. This ensures patient safety and maintains sterility standards.

• What materials are used in the construction of the Osteonics 6011 Hip Stem Series?

  The device is constructed from metal and polymer materials. The femoral stem is made of metal, while the liner component is polymer-based. These materials are chosen for their durability, biocompatibility, and ability to integrate with the existing bone structure for long-term stability.

• What regulatory pathway was followed for the Osteonics 6011 Hip Stem Series?

  The Osteonics 6011 Hip Stem Series received FDA 510(k) clearance (K905158) under a Traditional review in 1991. The decision was classified as 'Substantially Equivalent for Some Indications,' meaning it was determined to be as safe and effective as a legally marketed predicate device for certain applications. The device is classified under FDA regulation 888.3350 and falls under the Orthopedic advisory committee.