Cleared Traditional

K933719 - BIOSCREW ABSORBABLE INTERFERENCE SCREW

K933719 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 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

Submission Details

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.

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 559
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K933719.
PIONEER LABORATORIES CABLE PIN
K941174 · Pioneer Surgical Technology · 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
CANNULATED NAVICULAR SCREW
K931681 · Onyx Medical Corp. · Apr 1994
CORTICAL BONE SCREW
K931790 · Onyx Medical Corp. · Apr 1994