Cleared Traditional

K083635 - SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW

K083635 is an FDA 510(k) clearance for SMITH & NEPHEW BIOSURE PK INTERFERENCE ..., manufactured by Smith & Nephew Endoscopy, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K083635 · Smith & Nephew Endoscopy, Inc. · Orthopedic device
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Jan 2009
Decision
53d
Days
Class 2
Risk

K083635 is an FDA 510(k) clearance for the SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Smith & Nephew Endoscopy, Inc. (Andover, US). The FDA issued a Cleared decision on January 30, 2009 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith & Nephew Endoscopy, Inc. devices

FDA 510(k) Submission Details - K083635

510(k) Number K083635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2008
Decision Date January 30, 2009
Days to Decision 53 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K083635.
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