Cleared Traditional

K844787 - BIOMETRIC TOTAL HIP SYSTEM

K844787 is an FDA 510(k) clearance for BIOMETRIC TOTAL HIP SYSTEM, manufactured by Biomedics. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K844787 · Biomedics · Orthopedic device
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Apr 1985
Decision
130d
Days
Class 2
Risk

K844787 is an FDA 510(k) clearance for the BIOMETRIC TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biomedics (Los Angeles, US). The FDA issued a Cleared decision on April 19, 1985 after a review of 130 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 Biomedics devices

FDA 510(k) Submission Details - K844787

510(k) Number K844787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1984
Decision Date April 19, 1985
Days to Decision 130 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 122d · This submission: 130d
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 506
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K844787.
HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY
K852546 · Howmedica Corp. · Aug 1985
THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP
K852153 · Howmedica Corp. · Aug 1985
LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS
K852705 · Waldemar Link GmbH & Co. KG · Aug 1985
MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM
K844817 · Osteonics Corp. · Mar 1985
CFE ACETABULAR CUP
K844941 · Biomet, Inc. · Mar 1985
BROOKER ACETABULAR CUP
K845005 · Biomet, Inc. · Feb 1985