Cleared Traditional

K960087 - SORIBIE RESURFACING TOTAL ELBOW SYSTEM ...

K960087 is an FDA 510(k) clearance for SORIBIE RESURFACING TOTAL ELBOW SYSTEM ..., manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code JDB cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K960087 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
253d
Days
Class 2
Risk

K960087 is an FDA 510(k) clearance for the SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME). 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 September 20, 1996 after a review of 253 days - an extended review cycle.

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

FDA 510(k) Submission Details - K960087

510(k) Number K960087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date September 20, 1996
Days to Decision 253 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
131d slower than avg
Panel avg: 122d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDB Device Classification - Class 2, Special Controls

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 22
Devices cleared under the same product code (JDB) and FDA review panel - the closest regulatory comparables to K960087.
TORNIER TOTAL ELBOW PROSTHESIS
K011567 · Tornier · Jun 2001
CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
K983141 · Johnson & Johnson Professionals, Inc. · Nov 1998
ABC TOTAL ELBOW PROTHESIS
K972691 · Biomet, Inc. · Oct 1997
SORBIE TOTAL ELBOW SYSTEM
K955099 · Wrightmedicaltechnologyinc · Feb 1996
SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM
K880188 · Howmedica Corp. · Mar 1988
ROPER-TUKE ELBOW
K873660 · Orthopedic Systems, Inc. · Jan 1988