Cleared Traditional

K081205 - SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS

K081205 is an FDA 510(k) clearance for SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIO..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K081205 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
63d
Days
Class 2
Risk

K081205 is an FDA 510(k) clearance for the SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on July 1, 2008 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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.

FDA 510(k) Submission Details - K081205

510(k) Number K081205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2008
Decision Date July 01, 2008
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 130
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K081205.
SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS
K090686 · Sic Brevetti S.R.L. · Dec 2009
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
K091190 · Zimmer Spine, Inc. · Jul 2009
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
K081622 · Abbott Spine, Inc. · Aug 2008
BIOMET CABLE SYSTEM
K071271 · Biomet Manufacturing, Inc. · Oct 2007
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
K063017 · Aesculap, Inc. · Dec 2006
ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
K060009 · Abbott Spine, Inc. · Mar 2006
K081205 · SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
Download PDF FDA Summary Synthes (Usa)