Cleared Traditional

K983141 - CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS

K983141 is the FDA 510(k) clearance for CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS by Johnson & Johnson Professionals, Inc.. It is a Class 2 Orthopedic device (product code JDB) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K983141 · Johnson & Johnson Professionals, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
59d
Days
Class 2
Risk

K983141 is an FDA 510(k) clearance for the CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on November 6, 1998 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K983141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1998
Decision Date November 06, 1998
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 22
Devices cleared under the same product code (JDB) and FDA review panel - the closest regulatory comparables to K983141.
TORNIER ELBOW PROSTHESIS
K050848 · Tornier · Jul 2005
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
K031218 · Tornier · May 2003
TORNIER TOTAL ELBOW PROSTHESIS
K011567 · Tornier · Jun 2001
ABC TOTAL ELBOW PROTHESIS
K972691 · Biomet, Inc. · Oct 1997
SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
K960087 · Wrightmedicaltechnologyinc · Sep 1996
SORBIE TOTAL ELBOW SYSTEM
K955099 · Wrightmedicaltechnologyinc · Feb 1996