Cleared Traditional

K121606 - RESORB-X G

K121606 is the FDA 510(k) clearance for RESORB-X G by KLS-Martin L.P.. It is a Class 2 Neurology device (product code GWO) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K121606 · KLS-Martin L.P. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
230d
Days
Class 2
Risk

K121606 is an FDA 510(k) clearance for the RESORB-X G. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on January 17, 2013 after a review of 230 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5320 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all KLS-Martin L.P. devices

Submission Details

510(k) Number K121606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2012
Decision Date January 17, 2013
Days to Decision 230 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 148d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWO Plate, Cranioplasty, Preformed, Alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5320
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 Neurology devices follow this clearance model.

Regulatory Peers - GWO Plate, Cranioplasty, Preformed, Alterable

All 21
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K121606.
PEEK Customized Cranial Implant
K153248 · Stryker · Mar 2016
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
K152076 · Stryker · Aug 2015
UNIVERSAL NEURO 3 SYSTEM
K131775 · Stryker · Oct 2013
PEEK CUSTOMIZED CRAIAL IMPLANT KIT
K121153 · Stryker · Sep 2012
STRYKER QUIKFLAP STERILE PROCEDURE PACK
K120352 · Stryker · Jun 2012
STRYKER UNIVERSAL NEURO 3 SYSTEM
K112557 · Stryker · Jan 2012