Cleared Traditional

ENSPLINT TM BONE SCREW (K080778) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080778 · Sonoma Orthopedic Products, Inc. · Orthopedic device
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Jul 2008
Decision
113d
Days
Class 2
Risk

K080778 is an FDA 510(k) clearance for the ENSPLINT TM BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Sonoma Orthopedic Products, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on July 10, 2008 after a review of 113 days - within the typical 510(k) review window.

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: 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.

View all Sonoma Orthopedic Products, Inc. devices

Submission Details

510(k) Number K080778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2008
Decision Date July 10, 2008
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 401
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K080778.
DARCO SMALL SCREW
K082320 · Wrightmedicaltechnologyinc · Nov 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516 · Smith & Nephew, Inc. · Sep 2008
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700 · Synthes (Usa) · Jul 2008
SYNTHES 6.5MM MIDFOOT FUSION BOLT
K081071 · Synthes (Usa) · May 2008
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
K080943 · Synthes (Usa) · Apr 2008
DARCO HEADLESS COMPRESSION SCREW
K080850 · Wrightmedicaltechnologyinc · Apr 2008