Cleared Traditional

K070245 - CAPSURE PEDICLE SCREW SYSTEM

K070245 is an FDA 510(k) clearance for CAPSURE PEDICLE SCREW SYSTEM, manufactured by Spine Wave, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K070245 · Spine Wave, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
70d
Days
Class 2
Risk

K070245 is an FDA 510(k) clearance for the CAPSURE PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on April 5, 2007 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Spine Wave, Inc. devices

FDA 510(k) Submission Details - K070245

510(k) Number K070245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2007
Decision Date April 05, 2007
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 269
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K070245.
ROC LUMBAR SYSTEM
K063668 · Alphatec Spine, Inc. · May 2007
RANGE SPINAL SYSTEM
K070229 · K2m, Inc. · May 2007
4S SPINAL SYSTEM
K063708 · Taeyeon Medical Co., Ltd. · Apr 2007
SCIENT'X SPINAL SYSTEM
K062912 · Scient'X · Feb 2007
PILOT SPINAL SYSTEM
K063601 · Life Spine · Jan 2007
MODIFICATION TO EASYSPINE SYSTEM
K063794 · Ldr Spine USA · Jan 2007