Cleared Special

K013557 - LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW

K013557 is an FDA 510(k) clearance for LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW, manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 23-day FDA review.

K013557 · Walter Lorenz Surgical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
23d
Days
Class 2
Risk

K013557 is an FDA 510(k) clearance for the LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 16, 2001 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Walter Lorenz Surgical, Inc. devices

FDA 510(k) Submission Details - K013557

510(k) Number K013557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2001
Decision Date November 16, 2001
Days to Decision 23 days
Submission Type Special
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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K013557.
ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
K022827 · Linvatec Corp. · Nov 2002
AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
K022207 · Axya Medical, Inc. · Oct 2002
PRE-LOADED ULTRAFIX RC
K013553 · Linvatec Corp. · Dec 2001
METAL SCREW ANCHOR
K012503 · Biomet Manufacturing, Inc. · Oct 2001
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
K011912 · Axya Medical, Inc. · Aug 2001
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
K011007 · Arthrex, Inc. · Jun 2001