ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM— 510(k) K964215

Name: FDA 510(k) clearance K964215
Creator: U.S. Food and Drug Administration
Published: 1996-12-20

Substantially Equivalent

Smith & Nephew Endoscopy, Inc.

FDA 510(k) clearance K964215 for ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM, Substantially Equivalent on 1996-12-20. Applicant: Smith & Nephew Endoscopy, Inc.. Device class: 2.

Clearance details

Applicant: Smith & Nephew Endoscopy, Inc.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 1996-10-22
Decision date: 1996-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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 K964215

K-number listed on FDA's recall record

Z-0155-2016 — Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.Class II·Terminated·Smith & Nephew, Inc., Endoscopy Div.·20150910
Z-0156-2016 — Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.Class II·Terminated·Smith & Nephew, Inc., Endoscopy Div.·20150910
Z-0157-2016 — Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.Class II·Terminated·Smith & Nephew, Inc., Endoscopy Div.·20150910
Z-0158-2016 — Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.Class II·Terminated·Smith & Nephew, Inc., Endoscopy Div.·20150910

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964215.

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