Cleared Traditional

K970084 - LINK CERCLAGE WIRE SYSTEM

K970084 is an FDA 510(k) clearance for LINK CERCLAGE WIRE SYSTEM, manufactured by Turnkey Intergration USA, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K970084 · Turnkey Intergration USA, Inc. · Orthopedic device
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Mar 1997
Decision
63d
Days
Class 2
Risk

K970084 is an FDA 510(k) clearance for the LINK CERCLAGE WIRE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Turnkey Intergration USA, Inc. (Sarasota, US). The FDA issued a Cleared decision on March 13, 1997 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 Turnkey Intergration USA, Inc. devices

FDA 510(k) Submission Details - K970084

510(k) Number K970084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1997
Decision Date March 13, 1997
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 91
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K970084.
SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM
K974020 · Spinal Concepts, Inc. · Dec 1997
COMPRESSION CERCLAGE GUNDOLF CCG-GF
K973098 · Plus Orthopedics · Oct 1997
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE
K971741 · Howmedica Corp. · Jul 1997
DALL-MILES TROCHANTER CABLE SUPERGRIP
K962162 · Howmedica Corp. · Aug 1996
SILKON STAINLESS STEEL CABLE SYSTEM
K962132 · Osteonics Corp. · Aug 1996
PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE
K961267 · Pioneer Surgical Technology · Jun 1996