Cleared Special

K121178 - TRANSCORP ACIF SYSTEM

K121178 is an FDA 510(k) clearance for TRANSCORP ACIF SYSTEM, manufactured by Transcorp, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 443-day FDA review.

K121178 · Transcorp, Inc. · Orthopedic device
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Jul 2013
Decision
443d
Days
Class 2
Risk

K121178 is an FDA 510(k) clearance for the TRANSCORP ACIF SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Transcorp, Inc. (Byron Center, US). The FDA issued a Cleared decision on July 5, 2013 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Transcorp, Inc. devices

FDA 510(k) Submission Details - K121178

510(k) Number K121178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2012
Decision Date July 05, 2013
Days to Decision 443 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 122d · This submission: 443d
Pathway characteristics
Modification to existing cleared device.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 256
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K121178.
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