DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES— 510(k) K071417

Name: FDA 510(k) clearance K071417
Creator: U.S. Food and Drug Administration
Published: 2007-08-02

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K071417 for DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES, Substantially Equivalent on 2007-08-02. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2007-05-21
Decision date: 2007-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K071417

K-number listed on FDA's recall record

Z-0828-2013 — LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.Class I·Terminated·DePuy Orthopaedics, Inc.·20130104
Z-0829-2013 — LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.Class I·Terminated·DePuy Orthopaedics, Inc.·20130104
Z-0830-2013 — LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.Class I·Terminated·DePuy Orthopaedics, Inc.·20130104
Z-0831-2013 — LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.Class I·Terminated·DePuy Orthopaedics, Inc.·20130104

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071417.

Data sourced from openFDA. This site is unofficial and independent of the FDA.