Cleared Special

K123297 - COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM

K123297 is an FDA 510(k) clearance for COMPRESS SEGMENTAL HUMERAL REPLACEMENT ..., manufactured by Biomet Manufactuting Corp.. The device is a Class 2 Orthopedic device with product code MBF cleared through the Special 510(k) pathway after a 29-day FDA review.

K123297 · Biomet Manufactuting Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
29d
Days
Class 2
Risk

K123297 is an FDA 510(k) clearance for the COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (product code MBF), Class II - Special Controls.

Submitted by Biomet Manufactuting Corp. (Warsaw, US). The FDA issued a Cleared decision on November 20, 2012 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3670 - 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.

FDA 510(k) Submission Details - K123297

510(k) Number K123297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2012
Decision Date November 20, 2012
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.

MBF Device Classification - Class 2, Special Controls

Product Code MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3670
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 - MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

All 36
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