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Pro-Dense Core Decompression Procedure Kit

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K072597

Overview

The Pro-Dense Core Decompression Procedure Kit is a surgical instrument set designed for core decompression procedures, a technique used to relieve intraosseous pressure in conditions such as osteonecrosis of the femoral head. It includes manual surgical instruments and a bone void filler to facilitate the removal of necrotic bone and stabilize the femoral head during the procedure. This device is classified under orthopedic instrumentation and is intended for use in orthopedic surgery settings. The kit is structured to assist in creating a stable bone environment post-decompression.

The Pro-Dense Core Decompression Procedure Kit is supplied as a sterile, single-use device, intended for use in controlled surgical environments. It is regulated under FDA 510(k) clearance (K072597) and is intended for orthopedic applications. The kit does not contain MRI-compatible components, and its components are designed for one-time use only. Storage should follow manufacturer guidelines to maintain sterility and functionality until use. No additional regulatory approvals beyond the stated 510(k) clearance are referenced.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072597 Date15 Oct 2007ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
MQV
Device Class
Class II
Regulation
21 CFR Part 888.3045
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Pro-Dense Core Decompression Procedure Kit used for?

    The kit is designed for core decompression procedures, a surgical technique to relieve intraosseous pressure in conditions such as osteonecrosis of the femoral head. It includes instruments for removing necrotic bone and a bone void filler to stabilize the femoral head during the procedure.

  • How is the Pro-Dense Core Decompression Procedure Kit supplied?

    The kit is supplied as a sterile, single-use device intended for use in controlled surgical environments. It is designed for one-time use only and does not contain MRI-compatible components. Storage should follow manufacturer guidelines to maintain sterility and functionality until use.

  • What is the regulatory status of the Pro-Dense Core Decompression Procedure Kit?

    The device is regulated under FDA 510(k) clearance (K072597) and is classified under orthopedic instrumentation. It is intended for orthopedic applications in surgical settings. No additional regulatory approvals beyond the stated 510(k) clearance are referenced.

  • What components are included in the Pro-Dense Core Decompression Procedure Kit?

    The kit includes manual surgical instruments and a bone void filler specifically designed to facilitate the removal of necrotic bone and stabilize the femoral head during core decompression procedures. The components are structured to assist in creating a stable bone environment post-decompression.