Cleared Traditional

K990351 - BONE SCREWS

K990351 is an FDA 510(k) clearance for BONE SCREWS, manufactured by Bregma International Trading Company , Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K990351 · Bregma International Trading Company , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
116d
Days
Class 2
Risk

K990351 is an FDA 510(k) clearance for the BONE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Bregma International Trading Company , Ltd. (Saskatoon, Saskatchewan, CA). The FDA issued a Cleared decision on June 1, 1999 after a review of 116 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 Bregma International Trading Company , Ltd. devices

FDA 510(k) Submission Details - K990351

510(k) Number K990351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1999
Decision Date June 01, 1999
Days to Decision 116 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 122d · This submission: 116d
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 809
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K990351.
STAPLETAC BONE ANCHOR SYSTEM
K992277 · Influence, Inc. · Jul 1999
SPIN SNAP-OFF SCREW
K991477 · New Deal, S.A. · Jul 1999
BIO-INTERFERENCE SCREW
K990454 · Innovasive Devices, Inc. · Jul 1999
BONE MULCH SCREW SYSTEM
K991298 · Biomet, Inc. · May 1999
BOLD SCREW
K990622 · New Deal, S.A. · Apr 1999
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
K990776 · Aap Implantate AG · Apr 1999