Cleared Traditional

K874672 - ACE CORTICAL LAG SCREW

K874672 is the FDA 510(k) clearance for ACE CORTICAL LAG SCREW by Buckman Co., Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K874672 · Buckman Co., Inc. · Orthopedic device
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Dec 1987
Decision
28d
Days
Class 2
Risk

K874672 is an FDA 510(k) clearance for the ACE CORTICAL LAG SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on December 11, 1987 after a review of 28 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Buckman Co., Inc. devices

Submission Details

510(k) Number K874672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1987
Decision Date December 11, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
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 637
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K874672.
ACROMED CANCELLOUS BONE SCREW
K875053 · Buckman Co., Inc. · Jan 1988
ORTHOMET BONE SCREWS
K875050 · Orthomet, Inc. · Jan 1988
ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW
K874670 · Buckman Co., Inc. · Dec 1987
TITANIUM BONE SCREWS
K874130 · Orthopedic Systems, Inc. · Dec 1987
OMNIFIT BONE SCREW
K873251 · Osteonics Corp. · Sep 1987
CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM
K872156 · Concept, Inc. · Jul 1987