Cleared Traditional

K873660 - ROPER-TUKE ELBOW

K873660 is an FDA 510(k) clearance for ROPER-TUKE ELBOW, manufactured by Orthopedic Systems, Inc.. The device is a Class 2 Orthopedic device with product code JDB cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K873660 · Orthopedic Systems, Inc. · Orthopedic device
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Jan 1988
Decision
118d
Days
Class 2
Risk

K873660 is an FDA 510(k) clearance for the ROPER-TUKE ELBOW. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on January 6, 1988 after a review of 118 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 Orthopedic Systems, Inc. devices

FDA 510(k) Submission Details - K873660

510(k) Number K873660 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 10, 1987
Decision Date January 06, 1988
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
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 K873660.
SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
K960087 · Wrightmedicaltechnologyinc · Sep 1996
SORBIE TOTAL ELBOW SYSTEM
K955099 · Wrightmedicaltechnologyinc · Feb 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
ARIZONA RADIO CAPITELLAR TOTAL ELBOW
K812322 · Zimmer, Inc. · Jan 1982