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Blackstone Medical Inc Pillar Spacer System

by Blackstone Medical, Inc. 510(k)

Active United States

510(k) K081177

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081177 Date23 Jul 2008ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Blackstone Medical Inc Pillar Spacer System is a spinal implant device composed of polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers. It is designed for use in spinal fusion procedures as a vertebral body replacement device.

The system is supplied in multiple footprint sizes, various heights, and angles of lordosis, and includes integrated anterior screw holes. It is intended for use with autograft and supplemental internal fixation systems such as the Blackstone Medical ICON Modular Pedicle Screw System or the SFS Spinal Fixation System. The device received FDA 510(k) clearance under k-number K081177 on July 23, 2008, and is classified under product code MAX with orthopedic advisory committee review.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Pillar Spacer System used for?

    The Pillar Spacer System is designed for use in spinal fusion procedures as a vertebral body replacement device, intended to be used with autograft and supplemental internal fixation systems such as the Blackstone Medical ICON Modular Pedicle Screw System or the SFS Spinal Fixation System.

  • What materials is the Pillar Spacer System made of?

    The Pillar Spacer System is composed of polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers, which provide radiopacity for imaging visibility during and after implantation.

  • How is the Pillar Spacer System supplied and what sizes are available?

    The system is supplied in multiple footprint sizes, various heights, and angles of lordosis, and includes integrated anterior screw holes to accommodate different anatomical needs in spinal fusion surgery.

  • Is the Pillar Spacer System sterile and single-use?

    The device data does not specify sterility or single-use status; therefore, no claim can be made about whether the Pillar Spacer System is supplied sterile or intended for single use based on the provided information.