Cleared Traditional

K931187 - IMPLEX ACETABULAR CUP SCREW SYSTEM

K931187 is the FDA 510(k) clearance for IMPLEX ACETABULAR CUP SCREW SYSTEM by Implex Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K931187 · Implex Corp. · Orthopedic device
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Feb 1994
Decision
335d
Days
Class 2
Risk

K931187 is an FDA 510(k) clearance for the IMPLEX ACETABULAR CUP SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on February 7, 1994 after a review of 335 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 Implex Corp. devices

Submission Details

510(k) Number K931187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date February 07, 1994
Days to Decision 335 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 122d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K931187.
M. KUROSAKA INTERFERENCE FIXATION SCREW
K933738 · Depuy, Inc. · Feb 1994
ARTHROTEK INTERFERENCE SCREW
K934469 · Biomet, Inc. · Feb 1994
6.5 MM CANCELLOUS BONE SCREW
K931665 · Encore Orthopedics, Inc. · Feb 1994
INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR
K921481 · Acufex Microsurgical, Inc. · Aug 1993
ACUTRACT
K930834 · Acu Med, Inc. · Jul 1993
3.5MM UNIVERSAL COMPRESSION SCREW
K923477 · Howmedica Corp. · Mar 1993