Cleared Traditional

K980364 - HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS

K980364 is an FDA 510(k) clearance for HOWMEDICA AND HOWMEDICA LEIBINGER BONE ..., manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980364 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
90d
Days
Class 2
Risk

K980364 is an FDA 510(k) clearance for the HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on April 29, 1998 after a review of 90 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K980364

510(k) Number K980364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1998
Decision Date April 29, 1998
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 923
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K980364.
RCI FIXATION SCREWS
K980841 · Smith & Nephew, Inc. · May 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K981259 · Osteonics Corp. · May 1998
SYNTHES 3.0 MM PC-FIX SYSTEM
K981372 · Synthes (Usa) · May 1998
INNOVASIVE DEVICES MENISCAL SCREW
K980681 · Innovasive Devices, Inc. · Apr 1998
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW
K980440 · Depuy, Inc. · Apr 1998
BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW
K972919 · Bionx Implants, Inc. · Mar 1998