SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR— 510(k) K093897

Name: FDA 510(k) clearance K093897
Creator: U.S. Food and Drug Administration
Published: 2010-03-04

Substantially Equivalent

Smith & Nephew Inc., Endoscopy Div.

FDA 510(k) clearance K093897 for SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR, Substantially Equivalent on 2010-03-04. Applicant: Smith & Nephew Inc., Endoscopy Div.. Device class: 2.

Clearance details

Applicant: Smith & Nephew Inc., Endoscopy Div.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2009-12-18
Decision date: 2010-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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K102544 — SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY2011-01-05
K092551 — SMITH & NEPHEW INSTRUMENT TRAYS2010-09-14
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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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 K093897

K-number listed on FDA's recall record

Z-1756-2020 — Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901Class II·Ongoing·Smith & Nephew, Inc.·20200317
Z-1757-2020 — Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902Class II·Ongoing·Smith & Nephew, Inc.·20200317

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093897.

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