Cleared Traditional

K140879 - BIOSURE HEALICOIL PK INTERFERENCE SCREW

K140879 is an FDA 510(k) clearance for BIOSURE HEALICOIL PK INTERFERENCE SCREW, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K140879 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
105d
Days
Class 2
Risk

K140879 is an FDA 510(k) clearance for the BIOSURE HEALICOIL 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, Inc. (Andover, US). The FDA issued a Cleared decision on July 21, 2014 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K140879

510(k) Number K140879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2014
Decision Date July 21, 2014
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 566
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K140879.
ARTHREX FIBERTAK SUTURE ANCHOR
K140476 · Arthrex, Inc. · Aug 2014
G-FORCE GEN 2 SUTURE ANCHOR SYSTEM
K141011 · Wrightmedicaltechnologyinc · Jul 2014
PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE
K141711 · Pontis Orthopaeeics, LLC · Jul 2014
RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
K140324 · Depuy Mitek, A Johnson and Johnson Company · Jul 2014
MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
K133579 · Pontis Orthopaedics, LLC · Jun 2014
ACUMED SUTURE ANCHOR SYSTEM
K140925 · Acumed, LLC · May 2014