Cleared Traditional

K982719 - THE BONE TIE

K982719 is an FDA 510(k) clearance for THE BONE TIE, manufactured by Surgicraft , Ltd.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K982719 · Surgicraft , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
52d
Days
Class 2
Risk

K982719 is an FDA 510(k) clearance for the THE BONE TIE. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Surgicraft , Ltd. (Redditch, Worcs., GB). The FDA issued a Cleared decision on September 25, 1998 after a review of 52 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 Surgicraft , Ltd. devices

FDA 510(k) Submission Details - K982719

510(k) Number K982719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1998
Decision Date September 25, 1998
Days to Decision 52 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
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 159
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K982719.
METACARPAL FIXATION SYSTEM
K991064 · Medcanica, Inc. · Jun 1999
LACTOSORB BONE PIN
K990291 · Biomet, Inc. · Mar 1999
NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220
K983121 · Syntec Scientific Corp. · Oct 1998
RETROGRADE PEDIATRIC NAIL
K980854 · Encore Orthopedics, Inc. · Aug 1998
MITEK BTB ABSORBABLE (PLA) CROSS PIN
K974341 · Mitek Products · Apr 1998
MITEK BTB ABSORBABLE (PLA) CROSS PIN
K974291 · Mitek Products · Mar 1998