Cleared Traditional

GUARDIAN LIMB SALVAGE SYSTEM (K013035) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013035 · Wrightmedicaltechnologyinc · Orthopedic device
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Dec 2001
Decision
88d
Days
Class 2
Risk

K013035 is an FDA 510(k) clearance for the GUARDIAN LIMB SALVAGE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on December 7, 2001 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K013035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2001
Decision Date December 07, 2001
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 52
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K013035.
REPIPHYSIS LIMB SALVAGE SYSTEM
K021489 · Wrightmedicaltechnologyinc · Dec 2002
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
K021260 · Biomet, Inc. · Jun 2002
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
K013385 · Zimmer, Inc. · Jan 2002
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
K011810 · Depuy, Inc. · Sep 2001
AVL HINGE KNEE SYSTEM
K010774 · Biomet, Inc. · Apr 2001
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K002552 · Howmedica Osteonics Corp. · Nov 2000