Cleared Traditional

K080778 - ENSPLINT TM BONE SCREW

K080778 is an FDA 510(k) clearance for ENSPLINT TM BONE SCREW, manufactured by Sonoma Orthopedic Products, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K080778 · Sonoma Orthopedic Products, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K080778

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.

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 735
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K080778.
MERETE 3.0 AND 3.5 MM LOCKING SCREWS
K081513 · Merete Medical GmbH · Jul 2008
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700 · Synthes (Usa) · Jul 2008
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR
K072291 · Conmed Linvatec · Jul 2008
TLS FIXATION SYSTEM
K080974 · Fournitures Hospitalieres Industrie · Jul 2008
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
K081428 · Biocomposites, Ltd. · Jun 2008
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
K080088 · Biomet Manufacturing, Inc. · Jun 2008