Cleared Traditional

K851214 - T-SCREW

K851214 is an FDA 510(k) clearance for T-SCREW, manufactured by Northeast Iowa Podiatry. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K851214 · Northeast Iowa Podiatry · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
27d
Days
Class 2
Risk

K851214 is an FDA 510(k) clearance for the T-SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Northeast Iowa Podiatry (Waterloo, US). The FDA issued a Cleared decision on April 22, 1985 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K851214

510(k) Number K851214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1985
Decision Date April 22, 1985
Days to Decision 27 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
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 1064
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K851214.
LINK CANCELLOUS SCREWS
K854826 · Link America, Inc. · Dec 1985
LINK CORTICAL SCREWS
K854827 · Link America, Inc. · Dec 1985
FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER
K852026 · Warsaw Orthopedic, Inc. · May 1985
INTERMEDICS BONE SCREW
K850770 · Intermedics Orthopedics · Apr 1985
BONE SCREW
K831873 · W.L. Gore & Associates, Inc. · Aug 1983
SEIDEL INTRAMEDULLARY PLUG
K792205 · Howmedica Corp. · Dec 1979
K851214 · T-SCREW
Download PDF Northeast Iowa Podiat…