Cleared Traditional

K141905 - PRO-LINK WEDGE SYSTEM

K141905 is the FDA 510(k) clearance for PRO-LINK WEDGE SYSTEM by Life Spine. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K141905 · Life Spine · Orthopedic device
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Sep 2014
Decision
73d
Days
Class 2
Risk

K141905 is an FDA 510(k) clearance for the PRO-LINK WEDGE SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Life Spine (Hoffman Estates, US). The FDA issued a Cleared decision on September 26, 2014 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Life Spine devices

Submission Details

510(k) Number K141905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2014
Decision Date September 26, 2014
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K141905.
Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers
K143066 · Zimmer, Inc. · Nov 2014
Zimmer Plates and Screws (ZPS), Forte Screws
K142836 · Zimmer, Inc. · Nov 2014
Zimmer Periarticular Plating System
K142579 · Zimmer, Inc. · Oct 2014
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K141796 · Synthes USA Products, LLC · Aug 2014
VALOR HINDFOOT FUSION NAIL SYSTEM
K142121 · Wrightmedicaltechnologyinc · Aug 2014
ARTHREX ANKLE FUSION PLATING SYSTEM
K141735 · Arthrex, Inc. · Aug 2014