Cleared Traditional

K083798 - IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF

K083798 is an FDA 510(k) clearance for IMPIX ALIF LUMBAR IBF, manufactured by Medicrea Technologies. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 513-day FDA review.

K083798 · Medicrea Technologies · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2010
Decision
513d
Days
Class 2
Risk

K083798 is an FDA 510(k) clearance for the IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Medicrea Technologies (Douglassville, US). The FDA issued a Cleared decision on May 19, 2010 after a review of 513 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

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 Medicrea Technologies devices

FDA 510(k) Submission Details - K083798

510(k) Number K083798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date May 19, 2010
Days to Decision 513 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
391d slower than avg
Panel avg: 122d · This submission: 513d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 687
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K083798.
JULIET OL
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