Cleared Traditional

K973758 - BIOSCREW ABSORBABLE INTERFERENCE SREW

K973758 is an FDA 510(k) clearance for BIOSCREW ABSORBABLE INTERFERENCE SREW, 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 148-day FDA review.

K973758 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
148d
Days
Class 2
Risk

K973758 is an FDA 510(k) clearance for the BIOSCREW ABSORBABLE INTERFERENCE SREW. 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 February 27, 1998 after a review of 148 days - within the typical 510(k) review window.

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 - K973758

510(k) Number K973758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1997
Decision Date February 27, 1998
Days to Decision 148 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 122d · This submission: 148d
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 K973758.
AUTO-DRIVE BONE SCREW
K974785 · Osteomed Corp. · Mar 1998
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
K974756 · Biodynamic Technologies, Inc. · Mar 1998
MENISCAL REPAIR DEVICE
K974538 · Linvatec Corp. · Mar 1998
ULTIMATE COMPRESSION SCREW SYSTEM
K972722 · Orthopedic Designs, Inc. · Jan 1998
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW
K973309 · Vilex, Inc. · Jan 1998
DRG LARGE SCREW SYSTEM
K973810 · Dolphin Medical Technologies, Inc. · Jan 1998