Cleared Traditional

K960652 - BIOSCREW ABSORBABLE INTERFERENCE SCREW

K960652 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 273-day FDA review.

K960652 · Linvatec Corp. · Orthopedic device
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Nov 1996
Decision
273d
Days
Class 2
Risk

K960652 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 November 14, 1996 after a review of 273 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 - K960652

510(k) Number K960652 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 15, 1996
Decision Date November 14, 1996
Days to Decision 273 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
151d slower than avg
Panel avg: 122d · This submission: 273d
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 K960652.
LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
K963739 · Howmedica Leibinger, Inc. · Jan 1997
NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW
K963937 · Northwest Precision Technologies · Jan 1997
HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)
K955733 · Depuy, Inc. · Nov 1996
DEPUY MOTECH PEAK FIXATION SYSTEM
K963350 · Depuy, Inc. · Nov 1996
EZ-FIX CANNULATED SCREW SYSTEM
K962706 · Biodynamic Technologies, Inc. · Nov 1996
SYNTHES STERILE 4.5 MM CANNULATED SCREWS
K963172 · Synthes (Usa) · Nov 1996