Cleared Traditional

K875053 - ACROMED CANCELLOUS BONE SCREW

K875053 is the FDA 510(k) clearance for ACROMED CANCELLOUS BONE SCREW by Buckman Co., Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K875053 · Buckman Co., Inc. · Orthopedic device
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Jan 1988
Decision
42d
Days
Class 2
Risk

K875053 is an FDA 510(k) clearance for the ACROMED CANCELLOUS BONE 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 January 20, 1988 after a review of 42 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 K875053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date January 20, 1988
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
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 K875053.
ACUFEX INTERFERENCE SCREW AND SCREWDRIVER
K883910 · Acufex Microsurgical, Inc. · Oct 1988
ACE CANCELLOUS BONE SCREW
K882831 · Buckman Co., Inc. · Aug 1988
INTERFERENCE SCREW
K874676 · Concept, Inc. · Mar 1988
ORTHOMET BONE SCREWS
K875050 · Orthomet, Inc. · Jan 1988
ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW
K874670 · Buckman Co., Inc. · Dec 1987
ACE CORTICAL LAG SCREW
K874672 · Buckman Co., Inc. · Dec 1987