Cleared Traditional

K960940 - BIOSCREW ABSORBABLE INTERFERENCE SCREW

K960940 is an FDA 510(k) clearance for BIOSCREW ABSORBABLE INTERFERENCE SCREW, manufactured by Linvatec Corp.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K960940 · Linvatec Corp. · Orthopedic device
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Aug 1996
Decision
160d
Days
Class 2
Risk

K960940 is an FDA 510(k) clearance for the BIOSCREW ABSORBABLE INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on August 15, 1996 after a review of 160 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Linvatec Corp. devices

FDA 510(k) Submission Details - K960940

510(k) Number K960940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1996
Decision Date August 15, 1996
Days to Decision 160 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 122d · This submission: 160d
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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K960940.
SCARF THREAD-HEAD SCREW
K962236 · Landos, Inc. · Sep 1996
COMPRESSION SCREW
K962779 · Orthopaedic Biosystems, Ltd. · Aug 1996
INTERFERENCE SCREW
K960962 · Linvatec Corp. · Aug 1996
SYNTHES ANATOMICAL LOCKING PLATE SYSTEM
K961413 · Synthes (Usa) · Aug 1996
MEDICINELODGE, INC. SET SCREW
K961905 · Medicinelodge, Inc. · Aug 1996
SYNTHES 7.0/7.3 MM CANNULATED SCREWS
K962011 · Synthes (Usa) · Aug 1996