Cleared Traditional

SORBIE TOTAL ELBOW SYSTEM (K955099) - FDA 510(k) Clearance

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

K955099 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
90d
Days
Class 2
Risk

K955099 is an FDA 510(k) clearance for the SORBIE TOTAL ELBOW SYSTEM. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on February 5, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3160 - 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K955099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1995
Decision Date February 05, 1996
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDB Prosthesis, Elbow, Semi-constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3160
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 - JDB Prosthesis, Elbow, Semi-constrained, Cemented

All 14
Devices cleared under the same product code (JDB) and FDA review panel - the closest regulatory comparables to K955099.
CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
K983141 · Johnson & Johnson Professionals, Inc. · Nov 1998
ABC TOTAL ELBOW PROTHESIS
K972691 · Biomet, Inc. · Oct 1997
SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
K960087 · Wrightmedicaltechnologyinc · Sep 1996
SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM
K880188 · Howmedica Corp. · Mar 1988
POROCOAT MARK IV ELBOW
K823473 · Depuy, Inc. · Jan 1983
SUFACE REPLACEMENT ELBOW
K820957 · Howmedica Corp. · Jul 1982