Cleared Special

K070963 - REUNION HA FRACTURE STEM

K070963 is the FDA 510(k) clearance for REUNION HA FRACTURE STEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code HSD) cleared through the Special 510(k) pathway after a 29-day FDA review.

K070963 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
29d
Days
Class 2
Risk

K070963 is an FDA 510(k) clearance for the REUNION HA FRACTURE STEM. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on May 4, 2007 after a review of 29 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K070963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2007
Decision Date May 04, 2007
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 48
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K070963.
DEPUY GLOBAL AP CTA HUMERAL HEAD
K082715 · DePuy Orthopaedics, Inc. · Dec 2008
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
K080990 · DePuy Orthopaedics, Inc. · Aug 2008
SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
K072578 · Synthes (Usa) · Nov 2007
AEQUALIS RESURFACING HEAD
K062661 · Tornier · Dec 2006
MODULAR REPLACEMENT ELBOW SYSTEM
K062845 · Howmedica Osteonics Corp. · Dec 2006
AEQUALIS SHOULDER SYSTEM
K063081 · Tornier · Nov 2006