Cleared Traditional

K990353 - STAINLESS STEEL FIXATION PINS

K990353 is an FDA 510(k) clearance for STAINLESS STEEL FIXATION PINS, manufactured by Bregma International Trading Company , Ltd.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K990353 · Bregma International Trading Company , Ltd. · Orthopedic device
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Jun 1999
Decision
116d
Days
Class 2
Risk

K990353 is an FDA 510(k) clearance for the STAINLESS STEEL FIXATION PINS. Classified as Pin, Fixation, Threaded (product code JDW), 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 - K990353

510(k) Number K990353 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.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 77
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K990353.
TAC' PIN
K993910 · New Deal, S.A. · Feb 2000
DIGIT WIDGET
K992970 · Hand Biomechanics Lab, Inc. · Nov 1999
DEPUY ROCKWOOD CLAVICLE PIN
K991649 · Depuy, Inc. · Jul 1999
SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01
K983757 · Syntec Scientific Corp. · Dec 1998
THREADED FIXATION PIN
K982931 · Sgarlato Laboratories, Inc. · Oct 1998
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
K982068 · Howmedica Corp. · Aug 1998