Cleared Traditional

K092082 - SYNERGY CANNULATED SCREW SYSTEM

K092082 is an FDA 510(k) clearance for SYNERGY CANNULATED SCREW SYSTEM, manufactured by Synergy Surgical Technologies, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K092082 · Synergy Surgical Technologies, LLC · Orthopedic device
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Oct 2009
Decision
85d
Days
Class 2
Risk

K092082 is an FDA 510(k) clearance for the SYNERGY CANNULATED SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synergy Surgical Technologies, LLC (San Diego, US). The FDA issued a Cleared decision on October 2, 2009 after a review of 85 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 Synergy Surgical Technologies, LLC devices

FDA 510(k) Submission Details - K092082

510(k) Number K092082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2009
Decision Date October 02, 2009
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 777
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K092082.
LEFORTE NEUROSYSTEM BONE SCREW
K091686 · Jeil Medical Corporation · Nov 2009
ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N
K092133 · Arthrocare Corp. · Nov 2009
ASCENSION CANNULATED SCREW SYSTEM
K092440 · Ascension Orthopedics, Inc. · Nov 2009
PARCUS PPEK CF INTERFERENCE SCREW
K091093 · Parcus Medical, LLC · Sep 2009
MERETE COMPRESSION SCREWS
K091798 · Merete Medical GmbH · Sep 2009
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
K090949 · Synthes (Usa) · Jul 2009