Cleared Traditional

K080280 - SUB-TALAR LOK, MODEL 7-11 MM

K080280 is an FDA 510(k) clearance for SUB-TALAR LOK, manufactured by Instratek, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K080280 · Instratek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
39d
Days
Class 2
Risk

K080280 is an FDA 510(k) clearance for the SUB-TALAR LOK, MODEL 7-11 MM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Instratek, Inc. (Spring, US). The FDA issued a Cleared decision on March 14, 2008 after a review of 39 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.

View all Instratek, Inc. devices

FDA 510(k) Submission Details - K080280

510(k) Number K080280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2008
Decision Date March 14, 2008
Days to Decision 39 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 122d · This submission: 39d
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 742
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K080280.
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
K080943 · Synthes (Usa) · Apr 2008
DARCO HEADLESS COMPRESSION SCREW
K080850 · Wrightmedicaltechnologyinc · Apr 2008
AAP CANNULATED SCREW AND DARCO HEADED SCREW
K080101 · Aap Implantate AG · Mar 2008
MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE
K080352 · Depuy Mitek, A Johnson & Johnson Company · Mar 2008
TWINFIX PK FP SUTURE ANCHOR
K073509 · Smith & Nephew, Inc. · Mar 2008
APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM
K073426 · Cayenne Medical, Inc. · Feb 2008