Cleared Traditional

K955733 - HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)

K955733 is an FDA 510(k) clearance for HYLOC INTERFERENCE SCREW (CANNULATED)/(..., manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K955733 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
336d
Days
Class 2
Risk

K955733 is an FDA 510(k) clearance for the HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED). Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 18, 1996 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K955733

510(k) Number K955733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date November 18, 1996
Days to Decision 336 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
214d slower than avg
Panel avg: 122d · This submission: 336d
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 974
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K955733.
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
K965073 · Smith & Nephew, Inc. · Feb 1997
LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
K963739 · Howmedica Leibinger, Inc. · Jan 1997
NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW
K963937 · Northwest Precision Technologies · Jan 1997
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K960652 · Linvatec Corp. · Nov 1996
DEPUY MOTECH PEAK FIXATION SYSTEM
K963350 · Depuy, Inc. · Nov 1996
EZ-FIX CANNULATED SCREW SYSTEM
K962706 · Biodynamic Technologies, Inc. · Nov 1996