Skip to content

Xia Stainless Steel System

by Howmedica Osteonics Corp.

510(k) K012870

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK012870 Date24 Sep 2001ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KWP
Device class
Class II
Regulation
21 CFR Part 888.3050
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Xia Stainless Steel System is an orthopedic fixation device used for spinal applications. It can be employed as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system for patients with degenerative disc disease, which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The system is manufactured by Howmedica Osteonics Corp. and is supplied as a stainless steel device. It received FDA 510(k) clearance on September 24, 2001, with the product code KWP and is classified under Class II with Special Controls. The device is not specified as single-use or reusable, and no information regarding MRI safety or storage conditions is provided.

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Questions

AI-generated answers, 22 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 Xia Stainless Steel System used for?

    The Xia Stainless Steel System is an orthopedic fixation device designed for spinal applications. It can be used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system for patients with degenerative disc disease, which is defined as back pain of discogenic origin with degeneration confirmed by history and radiographic studies.

  • Is the Xia Stainless Steel System single-use or reusable?

    The device is not specified as single-use or reusable in the provided information. This detail should be confirmed with the manufacturer Howmedica Osteonics Corp. for specific usage guidelines and recommendations.

  • What regulatory approvals does the Xia Stainless Steel System have?

    The Xia Stainless Steel System received FDA 510(k) clearance on September 24, 2001, with product code KWP and is classified under Class II with Special Controls. It was determined to be substantially equivalent to predicate devices for its intended use in spinal fixation.

  • What are the specifications of the Xia Stainless Steel System?

    The system is manufactured as a stainless steel device and can be configured for either anterior screw fixation or posterior hook and sacral/iliac screw fixation. No specific measurements or detailed technical specifications are provided in the available information.