Cleared Traditional

K071704 - SLEEVE AND BUTTON SOFT TISSUE DEVICES

K071704 is an FDA 510(k) clearance for SLEEVE AND BUTTON SOFT TISSUE DEVICES, manufactured by Biomet Sports Medicine, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K071704 · Biomet Sports Medicine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
88d
Days
Class 2
Risk

K071704 is an FDA 510(k) clearance for the SLEEVE AND BUTTON SOFT TISSUE DEVICES. 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 Biomet Sports Medicine, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 17, 2007 after a review of 88 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 Biomet Sports Medicine, Inc. devices

FDA 510(k) Submission Details - K071704

510(k) Number K071704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2007
Decision Date September 17, 2007
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
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 571
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K071704.
TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM
K080335 · Tornier, Inc. · Apr 2008
THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES
K073481 · Conmed Linvatec · Jan 2008
AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR
K070773 · Axya Medical, Inc. · Oct 2007
CONMED LINVATEC XO BUTTON
K070780 · Conmed Linvatec · Aug 2007
OPUS TWINLOCK KNOTLESS FIXATION DEVICE
K071374 · Arthrocare Corp. · Aug 2007
STRYKER PEEK TWINLOOP TAC
K070882 · Stryker Endoscopy · Jul 2007