EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)— 510(k) K111471

Substantially Equivalent

Medshape Solutions, Inc.

FDA 510(k) clearance K111471 for EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE), Substantially Equivalent on 2011-06-10. Applicant: Medshape Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Medshape Solutions, Inc.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2011-05-27
Decision date: 2011-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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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 K111471

K-number listed on FDA's recall record

Z-1276-2013 — ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone.Class II·Terminated·Medshape Solutions, INC.·20130404

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111471.

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