Cleared Traditional

K780497 - SPHERISTEM TOTAL HIP PROSTHESIS

K780497 is an FDA 510(k) clearance for SPHERISTEM TOTAL HIP PROSTHESIS, manufactured by American Ortomed Corp.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K780497 · American Ortomed Corp. · Orthopedic device
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Jun 1978
Decision
78d
Days
Class 2
Risk

K780497 is an FDA 510(k) clearance for the SPHERISTEM TOTAL HIP PROSTHESIS. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by American Ortomed Corp. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1978 after a review of 78 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K780497

510(k) Number K780497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1978
Decision Date June 14, 1978
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 122d · This submission: 78d
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 51
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K780497.
BDH UNIVERSAL HIP SYSTEM SURGEON
K833468 · Carbomedics, Inc. · Dec 1983
BIOPHASE IMPLANT MATERIAL
K792329 · Richard'S Medical Equip., Inc. · Jan 1980
PROSTHESIS, HIP, CATHCART, SCHILLER MOD.
K780773 · Depuy, Inc. · Jun 1978
TITANIUM MULLER TOTAL HIP
K780357 · Biomet, Inc. · Apr 1978
TOTAL HIP, NEW ENGLAND BAPTIST
K780329 · Depuy, Inc. · Mar 1978
TOTAL HIP, CHARNELY TYPE
K772120 · Depuy, Inc. · Dec 1977
K780497 · SPHERISTEM TOTAL HIP PROSTHESIS
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