Cleared Traditional

K770035 - SCREW

K770035 is an FDA 510(k) clearance for SCREW, manufactured by Orthopedic Equipment Co., Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K770035 · Orthopedic Equipment Co., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1977
Decision
4d
Days
Class 2
Risk

K770035 is an FDA 510(k) clearance for the SCREW, WADSWORTH OLECRANON. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Orthopedic Equipment Co., Inc.. The FDA issued a Cleared decision on January 14, 1977 after a review of 4 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 Orthopedic Equipment Co., Inc. devices

FDA 510(k) Submission Details - K770035

510(k) Number K770035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1977
Decision Date January 14, 1977
Days to Decision 4 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
118d faster than avg
Panel avg: 122d · This submission: 4d
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.