Cleared Traditional

K940207 - TITANIUM ALLOY BONE SCREWS

K940207 is an FDA 510(k) clearance for TITANIUM ALLOY BONE SCREWS, manufactured by Aesculap, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K940207 · Aesculap, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
179d
Days
Class 2
Risk

K940207 is an FDA 510(k) clearance for the TITANIUM ALLOY BONE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on July 12, 1994 after a review of 179 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K940207

510(k) Number K940207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1994
Decision Date July 12, 1994
Days to Decision 179 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
57d slower than avg
Panel avg: 122d · This submission: 179d
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 982
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K940207.
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
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K933719 · Linvatec Corp. · May 1994
CANNULATED CANCELLOUS SCREW
K931680 · Onyx Medical Corp. · May 1994
ACE 6.5 MM BONE SCREW
K931652 · Ace Medical Co. · Apr 1994