Cleared Traditional

K130635 - SEVIIN SURFACE REPLACEMENT SHOULDER

K130635 is an FDA 510(k) clearance for SEVIIN SURFACE REPLACEMENT SHOULDER, manufactured by Ingen Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K130635 · Ingen Orthopedics, LLC · Orthopedic device
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Aug 2013
Decision
168d
Days
Class 2
Risk

K130635 is an FDA 510(k) clearance for the SEVIIN SURFACE REPLACEMENT SHOULDER. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Ingen Orthopedics, LLC (Cranbury, US). The FDA issued a Cleared decision on August 26, 2013 after a review of 168 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - 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.

View all Ingen Orthopedics, LLC devices

FDA 510(k) Submission Details - K130635

510(k) Number K130635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2013
Decision Date August 26, 2013
Days to Decision 168 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 122d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSD Device Classification - Class 2, Special Controls

Product Code HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3690
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 - HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 58
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K130635.
HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
K142942 · Arthrosurface, Inc. · Dec 2014
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
K131298 · Exactech, Inc. · Nov 2013
ARTHREX UNIVERS II CA HEADS
K130675 · Arthrex, Inc. · Oct 2013
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714 · Smith & Nephew, Inc. · Sep 2012
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
K112900 · Lima Corporate S.P.A. · Jun 2012
DEPUY GLOBAL AP CTA HUMERAL HEAD
K082715 · DePuy Orthopaedics, Inc. · Dec 2008