Cleared Traditional

K102743 - ORTHO SOLUTIONS - STERILE

K102743 is an FDA 510(k) clearance for ORTHO SOLUTIONS - STERILE, manufactured by Ortho Solutions Limited. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K102743 · Ortho Solutions Limited · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
120d
Days
Class 1
Risk

K102743 is an FDA 510(k) clearance for the ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Ortho Solutions Limited (Prior Lake, US). The FDA issued a Cleared decision on January 20, 2011 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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 Ortho Solutions Limited devices

FDA 510(k) Submission Details - K102743

510(k) Number K102743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2010
Decision Date January 20, 2011
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 42
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K102743.
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
K063688 · The Anspach Effort, Inc. · Jan 2007
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
K043310 · Synthes (Usa) · Jan 2005
AESCULAP HILAN MOTOR SYSTEM
K973736 · Aesculap, Inc. · Dec 1997
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
K971544 · Synthes (Usa) · May 1997
RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:
K970088 · Richard Wolf Medical Instruments Corp. · Apr 1997
SYNTHES STERILE DRILL BITS
K962913 · Synthes (Usa) · Nov 1996