Cleared Traditional

K960940 - BIOSCREW ABSORBABLE INTERFERENCE SCREW

K960940 is the FDA 510(k) clearance for BIOSCREW ABSORBABLE INTERFERENCE SCREW by Linvatec Corp.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 556
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K960940.
ALTA FULLY THREADED CROSS-LOCKING SCREWS
K963398 · Howmedica Corp. · Oct 1996
SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER
K962823 · Synthes (Usa) · Oct 1996
INTERFERENCE SCREW
K960962 · Linvatec Corp. · Aug 1996
SYNTHES ANATOMICAL LOCKING PLATE SYSTEM
K961413 · Synthes (Usa) · Aug 1996
SYNTHES 7.0/7.3 MM CANNULATED SCREWS
K962011 · Synthes (Usa) · Aug 1996
DEPUY ADVANTAGE FIXATION SCREW SYSTEM
K961234 · Depuy, Inc. · Jun 1996