Cleared Traditional

K142528 - AnthroBridge-Screw 25,30,35,40,45,50mm

Also marketed or referenced as:
AnthroBridge- Proximal Module 4.0,4.5,5.0mm

K142528 is an FDA 510(k) clearance for AnthroBridge-Screw 25, manufactured by Agent Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K142528 · Agent Medical, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
104d
Days
Class 2
Risk

K142528 is an FDA 510(k) clearance for the AnthroBridge-Screw 25,30,35,40,45,50mm. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Agent Medical, LLC (Richmond, US). The FDA issued a Cleared decision on December 22, 2014 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 - K142528

510(k) Number K142528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2014
Decision Date December 22, 2014
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 Consultant

Engineering Consulting Services, Inc.
Al Lippincott

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 1056
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K142528.
Headless Compression Screw System
K143624 · Skeletal Dynamics, LLC · Jan 2015
CrossTie Intraosseous Fixation System
K141857 · Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem · Jan 2015
3.Omm Biomet Cannulated Screw System
K143188 · Biomet Manufacturing Corp · Dec 2014
AIS Odontoid Fracture Fixation System
K142707 · Aesculap Implant System, Inc. · Dec 2014
ProxiFuse Hammer Toe Device
K142490 · Cartiva, Inc. · Dec 2014
PhaLinx Hammertoe System
K142585 · Wrightmedicaltechnologyinc · Nov 2014
K142528 · AnthroBridge-Screw 25,30,35,40,45,50mm
Download PDF FDA Summary Agent Medical, LLC