Cleared Special

K082679 - LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X

K082679 is an FDA 510(k) clearance for LAKI HAND FIXATION SYSTEM, manufactured by Sintea Biotech, Inc.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Special 510(k) pathway after a 204-day FDA review.

K082679 · Sintea Biotech, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
204d
Days
Class 2
Risk

K082679 is an FDA 510(k) clearance for the LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Sintea Biotech, Inc. (Miami Beach, US). The FDA issued a Cleared decision on April 7, 2009 after a review of 204 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082679

510(k) Number K082679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date April 07, 2009
Days to Decision 204 days
Submission Type Special
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
82d slower than avg
Panel avg: 122d · This submission: 204d
Pathway characteristics
Modification to existing cleared device.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
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 - JEC Component, Traction, Invasive

All 65
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K082679.
Medline ReNewal Reprocessed Stryker External Fixation Devices
K163028 · Surgical Instrument Service and Savings, Inc. · Dec 2016
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HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
K102885 · Stryker Corp. · Jan 2011
F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
K072432 · Hand Biomechanics Lab, Inc. · Jan 2008
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
K071476 · Synthes (Usa) · Aug 2007
KLSA MARTIN HAND DISTRACTOR
K042066 · KLS-Martin L.P. · Aug 2004
K082679 · LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
Download PDF FDA Summary Sintea Biotech, Inc.