Cleared Traditional

K102143 - SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM

K102143 is an FDA 510(k) clearance for SUSPENSION ACROMIOCLAVICULAR (AC) REPAI..., manufactured by Suspension Orthopaedic Solutions, LLC. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K102143 · Suspension Orthopaedic Solutions, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
131d
Days
Class 2
Risk

K102143 is an FDA 510(k) clearance for the SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Suspension Orthopaedic Solutions, LLC (Shelton, US). The FDA issued a Cleared decision on December 8, 2010 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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.

FDA 510(k) Submission Details - K102143

510(k) Number K102143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2010
Decision Date December 08, 2010
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 229
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K102143.
SUPER STAPLE(TM) CLASSIC
K123363 · Metric Medical Devices, Inc. · Jan 2013
VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
K112837 · Vilex, Inc. · Oct 2012
MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES
K102387 · Mediscope Manufacturing, Inc. · Oct 2011
OSSTAPLE CHILL
K102107 · Biomedical Ent., Inc. · Sep 2010
OSTEORAPTOR SUTURE ANCHOR
K082215 · Smith & Nephew Inc., Endoscopy Division · Nov 2008
COMPOSITE HITCH SUTURE ANCHOR
K081172 · Biomet Manufacturing Corp · Jul 2008
K102143 · SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM
Download PDF FDA Summary Suspension Orthopaedi…