Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon

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

510(k) Number

K111472 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K121509 Active Cleared 5 Nov 2012

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  Class II

  FDA 510(k) K130084 Active Cleared 3 May 2013

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• Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / Rlp, Uncoated; Tibial Insert / Baseplate...

  Class II

  FDA 510(k) K112285 Active Cleared 4 Nov 2011

• Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert

  Class II

  FDA 510(k) K121636 Active Cleared 24 Oct 2012

• What is the Helicon Hip System used for?

  The Helicon Hip System is designed for primary or revision total hip arthroplasty. It is a semi-constrained prosthesis intended to restore hip joint function in patients requiring hip replacement due to arthritis, fracture, or other degenerative conditions.

• How is the Helicon Hip System supplied and is it sterile?

  The device is supplied non-sterile and intended for single use. It must be sterilized by the healthcare provider prior to implantation, as it is not provided in a sterile condition from the manufacturer.

• What materials are used in the Helicon Hip System components?

  The system includes a monolithic titanium alloy femoral stem with dual wedge geometry and 135° neck-shaft angle, a cobalt-chromium (CoCr) femoral head, a titanium alloy acetabular shell, and a non-crosslinked ultra-high-molecular-weight polyethylene (UHMWPE) insert.

• What regulatory pathway was used for the Helicon Hip System?

  The Helicon Hip System received FDA 510(k) clearance (K111472) on September 6, 2011, and is classified as a Class II medical device under product code LPH for prosthesis, hip, semi-constrained, metal/polymer, porous uncemented.