Cleared Traditional

K931665 - 6.5 MM CANCELLOUS BONE SCREW

K931665 is an FDA 510(k) clearance for 6.5 MM CANCELLOUS BONE SCREW, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K931665 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
318d
Days
Class 2
Risk

K931665 is an FDA 510(k) clearance for the 6.5 MM CANCELLOUS BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 318 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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K931665

510(k) Number K931665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1993
Decision Date February 17, 1994
Days to Decision 318 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
196d slower than avg
Panel avg: 122d · This submission: 318d
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 640
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K931665.
CONCEPT CANNULATED INTEREFERENCE SCREW
K933352 · Linvatec Corp. · Feb 1994
M. KUROSAKA INTERFERENCE FIXATION SCREW
K933738 · Depuy, Inc. · Feb 1994
ARTHROTEK INTERFERENCE SCREW
K934469 · Biomet, Inc. · Feb 1994
INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW
K930980 · Instrument Makar, Inc. · Feb 1994
IMPLEX ACETABULAR CUP SCREW SYSTEM
K931187 · Implex Corp. · Feb 1994
BONE SCREWS
K923841 · Instrument Makar, Inc. · Oct 1993