Cleared Traditional

K873627 - CTI STRAIGHT STEM

K873627 is an FDA 510(k) clearance for CTI STRAIGHT STEM, manufactured by Orthopedic Systems, Inc.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K873627 · Orthopedic Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1987
Decision
113d
Days
Class 2
Risk

K873627 is an FDA 510(k) clearance for the CTI STRAIGHT STEM. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on December 30, 1987 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 - K873627

510(k) Number K873627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1987
Decision Date December 30, 1987
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDG Device Classification - Class 2, Special Controls

Product Code JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

All 43
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K873627.
OPTI-FIX COLLARED FEMORAL COMPONENTS
K874868 · Richards Medical Co., Inc. · Jan 1988
PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K874575 · Dow Corning Wright · Jan 1988
AML CALCAR FEMORAL PROSTHESIS
K874100 · Depuy, Inc. · Dec 1987
WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO
K874740 · Dow Corning Wright · Dec 1987
THOMPSON HIP PROSTHESIS
K874617 · Orthopedic Systems, Inc. · Dec 1987
HOWMEDICA PCA COLLARED FEMORAL STEM
K873458 · Howmedica Corp. · Sep 1987