Cleared Special

K102107 - OSSTAPLE CHILL

K102107 is an FDA 510(k) clearance for OSSTAPLE CHILL, manufactured by Biomedical Ent., Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Special 510(k) pathway after a 38-day FDA review.

K102107 · Biomedical Ent., Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
38d
Days
Class 2
Risk

K102107 is an FDA 510(k) clearance for the OSSTAPLE CHILL. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on September 3, 2010 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K102107

510(k) Number K102107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2010
Decision Date September 03, 2010
Days to Decision 38 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 122d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

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 222
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K102107.
VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
K112837 · Vilex, Inc. · Oct 2012
MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES
K102387 · Mediscope Manufacturing, Inc. · Oct 2011
SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM
K102143 · Suspension Orthopaedic Solutions, LLC · Dec 2010
OSTEORAPTOR SUTURE ANCHOR
K082215 · Smith & Nephew Inc., Endoscopy Division · Nov 2008
COMPOSITE HITCH SUTURE ANCHOR
K081172 · Biomet Manufacturing Corp · Jul 2008
ENDOBUTTON CONTINUOUS LOOP (CL)
K081098 · Smith & Nephew Inc., Endoscopy Division · Jul 2008