Synthetic Seeding Spacer (SS9 X 50-50 +3 more) - SS9 X 55-50

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K100847 ↗

FDA Product Code

KXK

Models / Variants

SS9 X 50-50

SS9 X 55-50

SS9 X 55-150

SS9 X 1cm-30

Device Class

Class II

Regulation

21 CFR Part 892.5730

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Radioactive Seed Localization Needle

  Class II

  FDA 510(k) K111979 Active Cleared 18 Oct 2011

• Worldwide Medical Technologies Anchor Marker, Marker Strand and Marker

  Class II

  FDA 510(k) K083274 Active Cleared 8 Jan 2009

• Proclear Daily Wear Contact Lens

  Class II

  FDA 510(k) K952152 Active Cleared 27 Jul 1995

• 0.014 Floppy & 0.014 Intermediate Guide Wires W/Phosphorylcholine Polymer Coating & 4cm Radiopaque Tip

  Class II

  FDA 510(k) K961232 Active Cleared 26 Jun 1996

• 0.014 Intermediate Guide Wire W/Phosphorylcholine Polymer Coating

  Class II

  FDA 510(k) K955135 Active Cleared 9 Apr 1996

• What is the primary purpose of the Synthetic Seeding Spacer Model SS9 in a clinical setting?

  The Synthetic Seeding Spacer Model SS9 is designed specifically for brachytherapy procedures to create and maintain consistent spacing between radionuclide seeds during implantation. This ensures even distribution of seeds within the target tissue, which is critical for precise radiation delivery in cancer treatment, particularly in radiology applications.

• Are these spacers intended for single-use or reusable applications, and how should they be handled?

  The Synthetic Seeding Spacer Model SS9 is a single-use device, though it is supplied in sterile packaging for clinical use. Since they are non-sterile before packaging, they must be handled according to sterile medical device protocols to maintain integrity and prevent contamination during procedures.

• What sizes are available for the Synthetic Seeding Spacer Model SS9, and how might this affect selection?

  The SS9 is available in four sizes: SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, and SS9 X 1CM-30. These variations allow clinicians to select the appropriate spacer length and configuration based on the specific anatomical or procedural requirements, ensuring optimal seed distribution for the intended radiation therapy.

• How is the regulatory status of this device determined, and what does that mean for purchasing or use?

  The Synthetic Seeding Spacer Model SS9 was granted FDA 510K clearance in 2010 under the traditional review process, with a determination of substantial equivalence to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class II medical device (regulated under 892.5730) and is approved for use in radiology settings as described in the device’s intended purpose.

• How should the spacers be stored to ensure they remain suitable for clinical use?

  Since the spacers are supplied in sterile packaging, they should be stored in a clean, dry environment protected from physical damage or contamination. Adherence to manufacturer guidelines for sterile packaging integrity is essential to maintain sterility and usability until the time of use.