Cleared Special

K081700 - SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION

K081700 is an FDA 510(k) clearance for SYNTHES (USA) STERNAL FIXATION SYSTEM -..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 30-day FDA review.

K081700 · 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
30d
Days
Class 2
Risk

K081700 is an FDA 510(k) clearance for the SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on July 17, 2008 after a review of 30 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. 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 - K081700

510(k) Number K081700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date July 17, 2008
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K081700.
TIGER CANNULATED SCREW SYSTEM
K081510 · Trilliant Surgical, Ltd. · Aug 2008
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5
K073159 · Trauson (Jiangsu) Medical Instrument Co., Ltd. · Jul 2008
MERETE 3.0 AND 3.5 MM LOCKING SCREWS
K081513 · Merete Medical GmbH · Jul 2008
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR
K072291 · Conmed Linvatec · Jul 2008
ENSPLINT TM BONE SCREW
K080778 · Sonoma Orthopedic Products, Inc. · Jul 2008
TLS FIXATION SYSTEM
K080974 · Fournitures Hospitalieres Industrie · Jul 2008
K081700 · SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
Download PDF FDA Summary Synthes (Usa)