DEPUY RECLAIM REVISION HIP SYSTEM— 510(k) K102080

Name: FDA 510(k) clearance K102080
Creator: U.S. Food and Drug Administration
Published: 2010-11-23

Substantially Equivalent

Depuy(Ireland)

FDA 510(k) clearance K102080 for DEPUY RECLAIM REVISION HIP SYSTEM, Substantially Equivalent on 2010-11-23. Applicant: Depuy(Ireland). Device class: 2.

Clearance details

Applicant: Depuy(Ireland)
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2010-07-26
Decision date: 2010-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZO

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K253948 — Momentum Acetabular Cup System2026-09-02
K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various)2026-07-06
K260831 — Z1 Hip System2026-06-16
K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
K260037 — implantcast Packaging System Update2026-03-30

More clearances from Depuy(Ireland)

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K212683 — GLOBAL ICON Stemless Shoulder System2022-01-19
K192855 — DELTA XTEND(TM) Reverse Shoulder System2020-02-24
K190344 — DePuy Corail AMT Hip Prosthesis2019-11-01
K191779 — Attune Revision LPS Inserts2019-10-08
K192448 — Delta Xtend Revers Shoulder System2019-10-04

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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 K102080

K-number listed on FDA's recall record

Z-2082-2014 — RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.Class II·Terminated·DePuy Orthopaedics, Inc.·20140603
Z-2083-2014 — RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.Class II·Terminated·DePuy Orthopaedics, Inc.·20140603
Z-2084-2014 — RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.Class II·Terminated·DePuy Orthopaedics, Inc.·20140603

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102080.

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