Cleared Traditional

K101812 - CONSTRUX MINI PEEK SPACER SYSTEM

K101812 is an FDA 510(k) clearance for CONSTRUX MINI PEEK SPACER SYSTEM, manufactured by Orthofix, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K101812 · Orthofix, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
90d
Days
Class 2
Risk

K101812 is an FDA 510(k) clearance for the CONSTRUX MINI PEEK SPACER SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Orthofix, Inc. (Mckinney, US). The FDA issued a Cleared decision on September 27, 2010 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K101812

510(k) Number K101812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2010
Decision Date September 27, 2010
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 352
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K101812.
TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
K103033 · Zimmer Trabecular Metal Technology · Jan 2011
VU CPOD INTERVERTEBRAL BODU FUSION DEVICE
K101363 · Musculoskeletal Clinical Regulatory Advisers · Dec 2010
SMALL PLATEAU SPACER SYSTEM
K093093 · Life Spine · Oct 2010
TRANSCORP ACIF SYSTEM
K092794 · Transcorp, Inc. · Sep 2010
ENDOSKELETON TC
K100889 · Titan Spine, LLC · Jul 2010
ALEUTIAN IBF SYSTEM
K101302 · K2m, Inc. · Jul 2010
K101812 · CONSTRUX MINI PEEK SPACER SYSTEM
Download PDF FDA Summary Orthofix, Inc.