Cleared Traditional

K943160 - INTERFERENCE SCREW

K943160 is an FDA 510(k) clearance for INTERFERENCE SCREW, manufactured by Applied Osteo Systems, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K943160 · Applied Osteo Systems, Inc. · Orthopedic device
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Sep 1994
Decision
91d
Days
Class 2
Risk

K943160 is an FDA 510(k) clearance for the INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Applied Osteo Systems, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on September 30, 1994 after a review of 91 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 Applied Osteo Systems, Inc. devices

FDA 510(k) Submission Details - K943160

510(k) Number K943160 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 01, 1994
Decision Date September 30, 1994
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
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 1020
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K943160.
PIONEER LABORATORIES BONE SCREW
K940690 · Pioneer Surgical Technology · Nov 1994
AIMS CANNULATED ACL SCREW
K943539 · Smith & Nephew, Inc. · Oct 1994
MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER
K934366 · Mitek Surgical Products, Inc. · Oct 1994
PIONEER LABORATORIES CABLE PIN
K941174 · Pioneer Surgical Technology · Sep 1994
STAPLE, FIXATION BONE
K931155 · Roseburg SA · Sep 1994
ARTHROTEK SET SCREW
K932721 · Biomet, Inc. · Aug 1994