Cleared Traditional

K933719 - BIOSCREW ABSORBABLE INTERFERENCE SCREW

K933719 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 288-day FDA review.

K933719 · Linvatec Corp. · Orthopedic device
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May 1994
Decision
288d
Days
Class 2
Risk

K933719 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 May 17, 1994 after a review of 288 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 - K933719

510(k) Number K933719 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 02, 1993
Decision Date May 17, 1994
Days to Decision 288 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
166d slower than avg
Panel avg: 122d · This submission: 288d
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 K933719.
STAPLE, FIXATION BONE
K931155 · Roseburg SA · Sep 1994
ARTHROTEK SET SCREW
K932721 · Biomet, Inc. · Aug 1994
TITANIUM ALLOY BONE SCREWS
K940207 · Aesculap, Inc. · Jul 1994
CANNULATED CANCELLOUS SCREW
K931680 · Onyx Medical Corp. · May 1994
ACE 6.5 MM BONE SCREW
K931652 · Ace Medical Co. · Apr 1994
CANNULATED NAVICULAR SCREW
K931681 · Onyx Medical Corp. · Apr 1994