Cleared Traditional

K830750 - CEMENTED 101 32 FEMORAL COMPONENT

K830750 is an FDA 510(k) clearance for CEMENTED 101 32 FEMORAL COMPONENT, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K830750 · Intermedics Orthopedics · Orthopedic device
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May 1983
Decision
112d
Days
Class 2
Risk

K830750 is an FDA 510(k) clearance for the CEMENTED 101 32 FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Mchenry, US). The FDA issued a Cleared decision on May 2, 1983 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K830750

510(k) Number K830750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1983
Decision Date May 02, 1983
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K830750.
CFE TOTAL HIP FEMORAL COMPONENT
K830313 · Biomet, Inc. · May 1983
LUS ACETABULAR COMPONENT
K830209 · Biomet, Inc. · May 1983
HARRIS A.R. C. ACETABULAR CUP
K830857 · Howmedica Corp. · May 1983
POROCOAT DUAL-LOCK TOTAL HIP SYSTEM
K830004 · Depuy, Inc. · Apr 1983
SPECTRON PROXIMAL FEMORAL PROSTHESIS
K823723 · Richard'S Medical Equip., Inc. · Mar 1983
SPECTRON NECK REPLACEMENT PROSTHESIS
K823724 · Richard'S Medical Equip., Inc. · Mar 1983