Skip to content

Inter-op Porous Protrusio Shell With Sealable Screwholes

by Sulzer Orthopedics, Inc.

510(k) K970706

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 · Traditional NumberK970706 Date22 May 1997ClearedStatusActive

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  • Withdrawn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
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Inter-op Porous Protrusio Shell With Sealable Screwholes is a porous coated hemispherical shell device designed for biological fixation to bone without the use of bone cement. It has a porous coating with a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns.

This device is used in revision hip arthroplasty procedures and is supplied as a single-use implant. It has received FDA 510(k) clearance with the product code LPH and authorization number K970706. The device is manufactured by Sulzer Orthopedics, Inc. and is stored according to the manufacturer's instructions.

Other devices from Sulzer Orthopedics, Inc.

See all devices from Sulzer Orthopedics, Inc. →

Questions

AI-generated answers, 25 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 Inter-op Porous Protrusio Shell used for?

    The Inter-op Porous Protrusio Shell is designed for biological fixation to bone without bone cement in revision hip arthroplasty procedures. Its porous coating promotes bone ingrowth for secure implant integration.

  • What are the specifications of the porous coating on this device?

    The porous coating has a volume porosity between 30-70%, average pore size between 100-1,000 microns, interconnecting porosity, and coating thickness between 500-1,500 microns, designed to facilitate bone ingrowth.

  • Is this device single-use or reusable?

    The Inter-op Porous Protrusio Shell is supplied as a single-use implant and should not be reused or resterilized according to the manufacturer's instructions.

  • What regulatory authorization does this device have?

    The device has received FDA 510(k) clearance with product code LPH and authorization number K970706, deemed substantially equivalent to predicate devices for revision hip arthroplasty.