Scorpio Posterior Cruciate Retaining Total Knee System

• • Terminated Z-1634-2015 FDA Class II ·initiated 15 Aug 2014

  The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

• 3 recalls, same reason

  • Terminated Z-0466-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0467-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0468-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009

  It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.

• 2 recalls, same reason

  • Terminated Z-0058-06 FDA Unclassified (pre-2012) ·initiated 11 Aug 2005
  • Terminated Z-0059-06 FDA Unclassified (pre-2012) ·initiated 11 Aug 2005

  The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.

• • Terminated Z-1381-2008 FDA Unclassified (pre-2012) ·initiated 8 Feb 2005

  Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component.

Full name

Osteonics Scorpio Posterior Cruciate Retaining Total Knee System

510(k) Number

K974556 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 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 Scorpio Posterior Cruciate Retaining Total Knee System used for?

  This system is designed for total knee arthroplasty, specifically to replace damaged knee joint surfaces while preserving the posterior cruciate ligament. It is intended for patients suffering from degenerative, rheumatoid, or post-traumatic arthritis, aiming to restore knee function and relieve pain by providing a stable and durable prosthetic implant.

• How is the Scorpio PC Retaining Total Knee System supplied and prepared for use?

  The system is supplied as a sterile, single-use orthopedic implant. It must be handled and stored according to sterile medical device procedures to ensure its integrity before surgical use. Components are available in right and left configurations, with variations in surface textures and fixation lugs to better match individual patient anatomies.

• Are the femoral components of this system reusable or single-use?

  The femoral components of the Scorpio Posterior Cruciate Retaining Total Knee System are intended for single-use only. This aligns with standard orthopedic implant practices to maintain sterility and reduce infection risks during surgery.

• What materials are used in the femoral components of this system?

  The femoral components are fabricated from cobalt chromium alloy. This material is chosen for its strength, durability, and biocompatibility, ensuring long-term stability and performance within the knee joint.

• How should the Scorpio PC Retaining Total Knee System be stored prior to use?

  The system must be stored in accordance with sterile medical device protocols to preserve its integrity. This includes maintaining sealed packaging, protecting from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions to ensure readiness for surgical use.