Cleared Traditional

K931734 - INTERMEDICS ORTHOPEDICS DRILL BITS

K931734 is an FDA 510(k) clearance for INTERMEDICS ORTHOPEDICS DRILL BITS, manufactured by Intermedics Orthopedics. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K931734 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
321d
Days
Class 1
Risk

K931734 is an FDA 510(k) clearance for the INTERMEDICS ORTHOPEDICS DRILL BITS. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K931734

510(k) Number K931734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1993
Decision Date February 22, 1994
Days to Decision 321 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
199d slower than avg
Panel avg: 122d · This submission: 321d
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 33
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K931734.
STRYKER TOTAL PERFORMANCE SYSTEM
K943589 · Stryker Corp. · Dec 1994
SURGICAL INSTRUMENTS AND ACCESSORIES
K942956 · Stryker Corp. · Sep 1994
TOTAL KNEE KIT
K932918 · Biodynamic Technologies, Inc. · Sep 1994
ARTHREX AR-8200 SHAVER SYSTEM
K932699 · Arthrex, Inc. · Jan 1994
ACUFEX STERILE DRILLS
K931837 · Acufex Microsurgical, Inc. · Jan 1994
CKS OSCILLATING SAW BLADE
K921131 · Techmedica, Inc. · Jun 1992