Cleared Traditional

K962779 - COMPRESSION SCREW

K962779 is an FDA 510(k) clearance for COMPRESSION SCREW, manufactured by Orthopaedic Biosystems, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K962779 · Orthopaedic Biosystems, Ltd. · Orthopedic device
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Aug 1996
Decision
37d
Days
Class 2
Risk

K962779 is an FDA 510(k) clearance for the COMPRESSION SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Orthopaedic Biosystems, Ltd. (Scotsdale, US). The FDA issued a Cleared decision on August 23, 1996 after a review of 37 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 Orthopaedic Biosystems, Ltd. devices

FDA 510(k) Submission Details - K962779

510(k) Number K962779 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 17, 1996
Decision Date August 23, 1996
Days to Decision 37 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
85d faster than avg
Panel avg: 122d · This submission: 37d
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 804
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K962779.
TWIST-OFF SCREW
K962233 · Landos, Inc. · Oct 1996
SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER
K962823 · Synthes (Usa) · Oct 1996
SCARF THREAD-HEAD SCREW
K962236 · Landos, Inc. · Sep 1996
INTERFERENCE SCREW
K960962 · Linvatec Corp. · Aug 1996
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K960940 · Linvatec Corp. · Aug 1996
SYNTHES ANATOMICAL LOCKING PLATE SYSTEM
K961413 · Synthes (Usa) · Aug 1996