Cleared Traditional

K871037 - CANCELLOUS FIXATION SCREW & WASHER FOR ...

K871037 is an FDA 510(k) clearance for CANCELLOUS FIXATION SCREW & WASHER FOR ..., manufactured by Concept, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K871037 · Concept, Inc. · Orthopedic device
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Mar 1987
Decision
8d
Days
Class 2
Risk

K871037 is an FDA 510(k) clearance for the CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 25, 1987 after a review of 8 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 Concept, Inc. devices

FDA 510(k) Submission Details - K871037

510(k) Number K871037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1987
Decision Date March 25, 1987
Days to Decision 8 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
114d faster than avg
Panel avg: 122d · This submission: 8d
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 K871037.
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
URESIL T-SYSTEM BONE SCREWS
K870141 · Uresil Corp. · Feb 1987
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
K864633 · Howmedica Corp. · Dec 1986
CANCELLOUS BONE SCREW
K864626 · Dow Corning Wright · Dec 1986