Cleared Traditional

K820957 - SUFACE REPLACEMENT ELBOW

K820957 is the FDA 510(k) clearance for SUFACE REPLACEMENT ELBOW by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDB) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K820957 · Howmedica Corp. · Orthopedic device
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Jul 1982
Decision
87d
Days
Class 2
Risk

K820957 is an FDA 510(k) clearance for the SUFACE REPLACEMENT ELBOW. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 87 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 Howmedica Corp. devices

Submission Details

510(k) Number K820957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1982
Decision Date July 02, 1982
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
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 K820957.
SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM
K880188 · Howmedica Corp. · Mar 1988
ROPER-TUKE ELBOW
K873660 · Orthopedic Systems, Inc. · Jan 1988
POROCOAT MARK IV ELBOW
K823473 · Depuy, Inc. · Jan 1983
ARIZONA RADIO CAPITELLAR TOTAL ELBOW
K812322 · Zimmer, Inc. · Jan 1982
PRITCHARD SURFACE REPLACEMENT ELBOW
K810847 · Depuy, Inc. · May 1981
TRIAXIAL
K802348 · Johnson & Johnson Professionals, Inc. · Feb 1981