Cleared Traditional

K962913 - SYNTHES STERILE DRILL BITS

K962913 is the FDA 510(k) clearance for SYNTHES STERILE DRILL BITS by Synthes (Usa). It is a Class 1 Orthopedic device (product code HWE) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K962913 · Synthes (Usa) · Orthopedic device
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Nov 1996
Decision
111d
Days
Class 1
Risk

K962913 is an FDA 510(k) clearance for the SYNTHES STERILE DRILL BITS. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on November 14, 1996 after a review of 111 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 Synthes (Usa) devices

Submission Details

510(k) Number K962913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1996
Decision Date November 14, 1996
Days to Decision 111 days
Submission Type Traditional
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
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 31
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K962913.
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
STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES
K962800 · Stryker Instruments · Sep 1996
POWERCUT GOLD SURGICAL SYSTEM
K962022 · Baxter Healthcare Corp · Aug 1996
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
K961970 · Stryker Corp. · Jul 1996