Cleared Traditional

K921481 - INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCR...

K921481 is the FDA 510(k) clearance for INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCR... by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 512-day FDA review.

K921481 · Acufex Microsurgical, Inc. · Orthopedic device
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Aug 1993
Decision
512d
Days
Class 2
Risk

K921481 is an FDA 510(k) clearance for the INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on August 24, 1993 after a review of 512 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K921481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1992
Decision Date August 24, 1993
Days to Decision 512 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
390d slower than avg
Panel avg: 122d · This submission: 512d
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 562
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K921481.
ARTHROTEK INTERFERENCE SCREW
K934469 · Biomet, Inc. · Feb 1994
6.5 MM CANCELLOUS BONE SCREW
K931665 · Encore Orthopedics, Inc. · Feb 1994
IMPLEX ACETABULAR CUP SCREW SYSTEM
K931187 · Implex Corp. · Feb 1994
ACUTRACT
K930834 · Acu Med, Inc. · Jul 1993
3.5MM UNIVERSAL COMPRESSION SCREW
K923477 · Howmedica Corp. · Mar 1993
ARTHREX CANNULATED INTERFERENCE SCREW
K915424 · Arthrex, Inc. · Feb 1993